Trial Outcomes & Findings for Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian (NCT NCT04670068)
NCT ID: NCT04670068
Last Updated: 2025-12-22
Results Overview
Dose-limiting toxicity (DLT) assessments will include toxicities that are at least possibly related to the CAR.B7-H3 T cell product and that occur from the day of the initial infusion through four weeks after the final administration. DLTs are defined as toxicities of Grade ≥3. All toxicities will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, which rates severity from Grade 1 (mild) to Grade 5 (death).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Up to 10 weeks (Up 4 weeks after the last CAR-T cell infusion)
Results posted on
2025-12-22
Participant Flow
Participants enrolled between 01/27/2021 - 12/19/2024 one center in North Carolina.
Participant milestones
| Measure |
Arm 1 - Dose Level 1
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2- Dose Level 2
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 - Dose Level 1
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2- Dose Level 2
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian
Baseline characteristics by cohort
| Measure |
Arm 1 - Dose Level 1
n=3 Participants
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2 - Dose Level 2
n=1 Participants
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
4 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=18 Participants
|
1 participants
n=102 Participants
|
4 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 10 weeks (Up 4 weeks after the last CAR-T cell infusion)Dose-limiting toxicity (DLT) assessments will include toxicities that are at least possibly related to the CAR.B7-H3 T cell product and that occur from the day of the initial infusion through four weeks after the final administration. DLTs are defined as toxicities of Grade ≥3. All toxicities will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, which rates severity from Grade 1 (mild) to Grade 5 (death).
Outcome measures
| Measure |
Arm 1 - Dose Level 1
n=3 Participants
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2- Dose Level 2
n=1 Participants
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) Based on National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 10 weeks (Up 4 weeks after the last CAR-T cell infusion)Dose-limiting toxicities (DLTs) will include any toxicity that is at least possibly related to the CAR.B7-H3 T cell product and occurs from the first infusion through 4 weeks after the final dose. DLTs are defined as Grade ≥3 cytokine release syndrome (CRS) that does not improve to Grade ≤2 within 7 days. CRS will be graded per protocol criteria on a Grade 1 (mild) to Grade 5 (death) scale.
Outcome measures
| Measure |
Arm 1 - Dose Level 1
n=3 Participants
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2- Dose Level 2
n=1 Participants
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) Based on Cytokine Release Syndrome (CRS)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 10 weeks (Up 4 weeks after the last CAR-T cell infusion)Dose-limiting toxicity (DLT) assessments will include any toxicity that is at least possibly related to the CAR.B7-H3 T cell product, occurring from the day of the first infusion through four weeks after the final cell product administration. DLTs are defined as Grade ≥3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or any other Grade ≥3 non-hematologic toxicity, including allergic reactions to T cell infusions. ICANS will be graded using protocol-defined criteria on a scale from Grade 1 (mild) to Grade 4 (critical). Cytokine Release Syndrome (CRS), if observed, will be graded on a scale from Grade 1 (mild) to Grade 5 (death), per the criteria outlined in the protocol.
Outcome measures
| Measure |
Arm 1 - Dose Level 1
n=3 Participants
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2- Dose Level 2
n=1 Participants
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) Based on Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after initial CAR-T cell infusionDisease control rate will be defined as the percentage of subjects with complete response (CR), partial response (PR), and/or stable disease at 6 months per RECIST 1.1 criteria. Radiographic response will be measured by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of lymphodepletion to the date of progression or death up to 5 yearsProgression free survival (PFS) will be measured from the time of lymphodepletion prior to infusion with CAR.B7-H3 to progression (as defined per RECIST 1.1) or death. Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of lymphodepletion to the date of death up to 5 yearsOverall survival (OS) will be measured from the date of lymphodepletion prior to CAR.B7-H3 T cell product administration to the date of death.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 - Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2- Dose Level 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - Dose Level 1
n=3 participants at risk
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2- Dose Level 2
n=1 participants at risk
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
Other adverse events
| Measure |
Arm 1 - Dose Level 1
n=3 participants at risk
Participants received Dose Level 1 (7.5x10\^7 cells/infusion).
|
Arm 2- Dose Level 2
n=1 participants at risk
Participants received Dose Level 2 (2x10\^8 cells/infusion).
|
|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
General disorders
Fever
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
General disorders
Generalized edema
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
General disorders
Pain
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Investigations
lactate dehydrogenase increased
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
3/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Renal and urinary disorders
Urinary tract pain
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
0.00%
0/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
100.0%
1/1 • Up to 91 days
Adverse events were monitored from procurement through the 4-week follow-up period after cellular treatment ended. All hospital admissions were considered Serious Adverse Event (SAE) per protocol.
|
Additional Information
Kelly Hoye, MS, CCRP Study coordinator - Clinical Immunotherapy Program
UNC Lineberger Comprehensive Cancer Center
Phone: 919-445-9676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place