Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma (NCT NCT03318861)
NCT ID: NCT03318861
Last Updated: 2023-10-19
Results Overview
A DLT is a KITE-585-related event with onset in the first 28 days following infusion. DLTs are defined by events and duration of events, including: * Any duration: Grade (GR) 4 cytokine release syndrome (CRS), KITE-585-related GR 5 adverse events (AE) and GR 4 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 3 or better in ≤ 72 hours, hypogammaglobulinemia, tumor lysis syndrome, acute renal toxicity requiring dialysis for ≤ 7 days, intubation for airway protection for ≤ 7 days and AE resolves to ≤ GR 1 within 2 weeks and baseline within 4 weeks * ≥ 72 hours: GR 3 CRS and GR 3 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 2 or better in ≤ 14 days, hypogammaglobulinemia and tumor lysis syndrome * ≥ 30 days: GR 4 hematologic AE with the exceptions of cytopenias attributable to ongoing or recurrent multiple myeloma
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
From KITE-585 infusion until 28 days after KITE-585 infusion
Results posted on
2023-10-19
Participant Flow
Participants were enrolled at study sites in the United States.
21 participants were screened.
Participant milestones
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
Participants with relapsed/refractory multiple myeloma (RRMM), received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day intravenous (IV) infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
Participants with relapsed/refractory multiple myeloma (RRMM), received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day intravenous (IV) infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
3
|
2
|
2
|
|
Overall Study
Enrolled But Never Treated
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Informed Consent Withdraw
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal of Consent From Further Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=4 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=4 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=3 Participants
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Age, Continuous
|
52.3 years
n=5 Participants
|
59.8 years
n=7 Participants
|
59.3 years
n=5 Participants
|
54.3 years
n=4 Participants
|
56.3 years
n=21 Participants
|
56.5 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=10 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
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=10 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=10 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From KITE-585 infusion until 28 days after KITE-585 infusionPopulation: DLT Evaluable Set included participants in the dose escalation period who received the target dose (± 20%) and were followed for at least 28 days after the first KITE-585 infusion; or received a dose of KITE-585 lower than 20% below the target dose for that cohort and experienced a DLT during the 28-day post-first-infusion period.
A DLT is a KITE-585-related event with onset in the first 28 days following infusion. DLTs are defined by events and duration of events, including: * Any duration: Grade (GR) 4 cytokine release syndrome (CRS), KITE-585-related GR 5 adverse events (AE) and GR 4 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 3 or better in ≤ 72 hours, hypogammaglobulinemia, tumor lysis syndrome, acute renal toxicity requiring dialysis for ≤ 7 days, intubation for airway protection for ≤ 7 days and AE resolves to ≤ GR 1 within 2 weeks and baseline within 4 weeks * ≥ 72 hours: GR 3 CRS and GR 3 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 2 or better in ≤ 14 days, hypogammaglobulinemia and tumor lysis syndrome * ≥ 30 days: GR 4 hematologic AE with the exceptions of cytopenias attributable to ongoing or recurrent multiple myeloma
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=4 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=4 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)Population: The Safety Analysis Set included all participants treated with any dose of KITE-585.
ORR: Percentage of participants who achieved a stringent CR (sCR), complete response (CR), partial response (PR), or very good PR (VGPR), as determined by IMWG Consensus Panel 1 Criteria. sCR: CR+normal free light chain (FLC) ratio, no clonal cells in BM by immunohistochemistry or immunofluorescence; CR: negative immunofixation (IFX) on serum and urine, no soft tissue plasmacytomas (STP), \<5% plasma cells in bone marrow (BM); PR: ≥50% decrease of serum M-protein + 24hr urinary M-protein decrease by ≥90% or \<200 mg/24hr. If unmeasurable serum and urine M-protein; and serum-free light assay; requires ≥ 50% decrease in the difference between involved and uninvolved FLC levels / ≥ 50% reduction in plasma cells (PC), provided baseline BM PC percentage was ≥ 30%, respectively. If present at baseline, ≥ 50% reduction in the size of STP is also required; VGPR: serum and urine M-protein detected by IFX but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hr.
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 Participants
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR) as Determined by Study Investigators According to the International Myeloma Working Group (IMWG) Consensus Panel 1 Criteria
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)Population: Participants in the Safety Analysis Set were analyzed. Participants not meeting the criteria for PD by the analysis data cutoff date were censored at their last evaluable disease assessment date before any other anti-cancer therapies including stem cell transplant.
PFS: Interval from first study drug dose date to the earlier of first documentation of definitive progressive disease (PD) per IMWG Consensus Panel 1 Criteria or death from any cause. PD: an increase of 25% from the lowest response value in 1 of the following: Serum and urine M-protein (absolute increase ≥ 0.5 g/dL and ≥ 200 mg/24 hours, respectively); In participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels (absolute increase \> 10 mg/dL); In participants without measurable serum and urine M-protein and without measurable disease by FLC levels, bone marrow PC percentage (absolute percentage ≥ 10%). Definite development of new bone lesions or STP or definite increase in the size of existing bone lesions or STPs; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder. Analysis was done using Kaplan-Meier (KM) estimate.
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 Participants
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) as Determined by Study Investigators According to the IMWG Consensus Panel 1
|
1.1 months
Interval 0.5 to 3.2
|
1.0 months
Interval 0.9 to 1.0
|
0.8 months
Interval 0.5 to 1.0
|
1.0 months
Interval 0.9 to 1.0
|
NA months
Interval 2.0 to
Median and upper limit of confidence interval (CI) were not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From KITE-585 infusion to date of data cutoff (maximum: 17.6 months)Population: Participants in the Safety Analysis Set were analyzed.
Overall survival is defined as the time from the first dose date of study drug to the date of death from any cause. Analysis was done using KM estimate. Participants who have not died by the analysis data cutoff date were censored at their last date known to be alive or cutoff date, whichever is earlier.
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 Participants
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 11.1 to
Median and upper limit of CI were not estimable due to insufficient number of events.
|
5.1 months
Interval 3.0 to
Upper limit of CI was not estimable due to insufficient number of events.
|
6.9 months
Interval 3.2 to
Upper limit of CI was not estimable due to insufficient number of events.
|
NA months
Interval 5.5 to
Median and upper limit of CI were not estimable due to insufficient number of events.
|
12.2 months
Lower and upper limit of CI were not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)Population: Participants in the Safety Analysis Set were analyzed.
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 Participants
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)Population: Participants in the Safety Analysis Set were analyzed.
Clinically significant laboratory abnormalities were defined as per investigator's discretion.
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 Participants
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first response to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)Population: Participants in the Safety Analysis Set who achieved a stringent CR (sCR), complete response (CR), partial response (PR), or very good PR (VGPR), as determined by IMWG Consensus Panel 1 Criteria were to be analyzed. As per changes in planned analysis, this outcome measure could not be analyzed at the data cutoff date due to an insufficient number of responders. Kite/Gilead did not collect the DOR data after the data cutoff date.
DOR is defined for participants who experience an objective response and is defined as the time from the date of their first objective response (which is subsequently confirmed) to PD per IMWG Consensus Panel 1 Criteria or death from any cause, whichever is earlier. Objective response is defined in Outcome measure 2.
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=1 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR) as Determined by Study Investigators According to the IMWG Consensus Panel 1
|
NA months
Due to an insufficient number of responders, this endpoint was not analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)Population: Participants in the Safety Analysis Set were to be analyzed. Estimates of the proportion of participants who have not required additional treatment for progressive multiple myeloma at selected time points were to be provided. As per changes in planned analysis, this outcome measure could not be analyzed at the data cutoff date due to a lack of events. Kite/Gilead did not collect data to analyze TTNT after the data cutoff date.
TTNT is defined as the length of time between the date of KITE-585 infusion to the date of initiation of the next therapy or death due to any cause, whichever is earlier.
Outcome measures
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 Participants
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 Participants
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Time to Next Treatment (TTNT)
|
NA months
Due to lack of events, this outcome measure was not analyzed.
|
NA months
Due to lack of events, this outcome measure was not analyzed.
|
NA months
Due to lack of events, this outcome measure was not analyzed.
|
NA months
Due to lack of events, this outcome measure was not analyzed.
|
NA months
Due to lack of events, this outcome measure was not analyzed.
|
Adverse Events
Dose Escalation: 3 x 10^7 KITE-585
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Escalation: 1 x 10^8 KITE-585
Serious events: 0 serious events
Other events: 3 other events
Deaths: 4 deaths
Dose Escalation: 3 x 10^8 KITE-585
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Escalation: 1 x 10^9 KITE-585
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 participants at risk
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
Other adverse events
| Measure |
Dose Escalation: 3 x 10^7 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^8 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 3 x 10^8 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Escalation: 1 x 10^9 KITE-585
n=3 participants at risk
Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
|
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
n=2 participants at risk
RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
100.0%
2/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
100.0%
3/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Oedema
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
100.0%
3/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Investigations
Thyroxine decreased
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Nervous system disorders
Cognitive disorder
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
100.0%
2/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
66.7%
2/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
0.00%
0/3 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
50.0%
1/2 • Adverse Events: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first. (maximum: 2.9 months) All-Cause Mortality: Enrollment up to 57.6 months
Adverse Events: The Safety Analysis Set included all participants treated with any dose of KITE-585. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled in the study.
|
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