Azer-cel Phase 1b Trial Results
Participants:
- Total Patients:10
- Cohort A:6 patients (treated with azer-cel and chemotherapy)
- Cohort B:4 patients (treated with azer-cel, chemotherapy, and IL-2)
Key Results:
- Complete Responses (CR):3 patients
- Cohort A:1 CR
- Cohort B:2 CRs
- Current Status:
- All 4 patients in Cohort B are still ongoing in the trial
- 1 patient in Cohort B is awaiting evaluation
- Previous Treatments:All patients had failed 4-5 prior treatments, including autologous CAR T therapies
- Safety:Treatment with azer-cel has been safe and tolerable
Future Plans:
- Cohort B regimenis planned to be included in the potential FDA Phase 2/3 package
Additional Information:
- Trial Locations:15 cancer centers in the U.S., with plans to open up to 5 sites in Australia
Evaluable Patients:
- Total Evaluable Patients:9 (qualified for at least their first 28-day scan)
- Cohort A:6 patients
- Responses:1 CR, 1 PR (Partial Response)
- Overall Response Rate (ORR):33%
- CR Rate:17%
- Durability:< 60 days
- Current Status:All patients no longer on trial
- Cohort B:3 patients (1 awaiting 28-day scan)
- Responses:2 CRs, 1 Stable Disease (SD)
- Overall Response Rate (ORR):67%
- CR Rate:67%
- Durability:>120 days and >90 days
- Current Status:All patients continue on trial
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