Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers (NCT NCT03912831)
NCT ID: NCT03912831
Last Updated: 2023-12-26
Results Overview
A DLT is defined as protocol-defined KITE-439 related Grade 3 events with onset within the first 21 days following KITE-439 infusion and which do not resolve to ≤Grade 2 events within 48 hours, ≥Grade 4 events with onset within the first 21 days following KITE-439 infusion, regardless of duration.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
First infusion date of KITE-439 up to 21 days
Results posted on
2023-12-26
Participant Flow
Participants were enrolled at study sites in the United States.
8 participants were screened. The study was terminated earlier than planned, and thus the study did not proceed to Phase 1B.
Participant milestones
| Measure |
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, intravenous (IV) infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^6 E7 T-cell receptor (TCR) T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, subcutaneous (SC) injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 5 × 10\^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 1 × 10\^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
3
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, intravenous (IV) infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^6 E7 T-cell receptor (TCR) T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, subcutaneous (SC) injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 5 × 10\^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 1 × 10\^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
Reason not Specified
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Participant
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
Baseline characteristics by cohort
| Measure |
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
n=3 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 5 × 10\^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 1 ×10\^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
54.0 years
STANDARD_DEVIATION NA • n=7 Participants
|
60.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
77.0 years
STANDARD_DEVIATION NA • n=4 Participants
|
59.7 years
STANDARD_DEVIATION 9.45 • n=21 Participants
|
40.0 years
STANDARD_DEVIATION NA • n=8 Participants
|
58.5 years
STANDARD_DEVIATION 11.28 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: First infusion date of KITE-439 up to 21 daysPopulation: DLT evaluable set included participants treated in Phase 1A who received the target dose (± 20%) and had the opportunity to be followed for at least 21 days after the KITE-439 infusion or received a dose of KITE-439 lower than the target dose and experienced a DLT within 21 days after the KITE-439 infusion.
A DLT is defined as protocol-defined KITE-439 related Grade 3 events with onset within the first 21 days following KITE-439 infusion and which do not resolve to ≤Grade 2 events within 48 hours, ≥Grade 4 events with onset within the first 21 days following KITE-439 infusion, regardless of duration.
Outcome measures
| Measure |
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
n=3 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 5 × 10\^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
n=1 Participants
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 1 × 10\^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
|---|---|---|---|---|---|---|
|
Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as evaluated by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
For participants who experience an objective response, DOR was defined as the time from the date of their first objective response to the date of disease progression per modified RECIST v1.1 or death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
PFS was defined as the time from the KITE-439 infusion date to the date of disease progression per modified RECIST v1.1 or death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
Overall survival was defined as the time from KITE-439 infusion to the date of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.4 yearsPopulation: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
n=3 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 5 × 10\^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 1 × 10\^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
Other adverse events
| Measure |
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10\^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
n=3 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 5 × 10\^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
n=1 participants at risk
Participants received conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m\^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10\^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose was 1 × 10\^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Cardiac disorders
Atrial flutter
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Ear and labyrinth disorders
Ear pain
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
66.7%
2/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Chills
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Face oedema
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Fatigue
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
66.7%
2/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Generalised oedema
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Malaise
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Mucosal dryness
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Oedema peripheral
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Pain
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
General disorders
Pyrexia
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
66.7%
2/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Heart rate increased
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
International normalised ratio increased
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
66.7%
2/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
Weight increased
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Investigations
White blood cell count decreased
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
66.7%
2/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
66.7%
2/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Psychiatric disorders
Confusional state
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Psychiatric disorders
Restlessness
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
100.0%
1/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
33.3%
1/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
66.7%
2/3 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
0.00%
0/1 • All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years).
Safety analysis set included all participants who were treated with any dose of KITE-439.
|
Additional Information
Medical Information
Kite, A Gilead Company
Phone: 844-454-5483 (1-844-454-KITE)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER