Prospective clinical studies with CAR T cells in patients with an early relapse
| Clinical trial . | Study design . | Definition of FHR . | Patients . | Clinical outcomes . |
|---|---|---|---|---|
| KarMMA-2, cohort 2a55 | Ide-cel | ER: progressive disease within 18 months from first-line treatment including induction, ASCT, and lenalidomide maintenance | n = 37 | ORR, 84% CR rate 46% PFS, median 11.4 mo 2-y OS, 85% DOR, median • Overall population, 16 mo • Patients in CR, 24 mo |
| KarMMA-2, cohort 2c57 | Ide-cel | Inadequate response (less than VGPR) after up-front ASCT | n = 31 | ORR, 87% CR rate, 74% MRD rates (10−5), 42% |
| CARTITUDE 2, cohort b56 | Cilta-cel | ER: progressive disease after initial therapy including PIs and IMiDs within 12 months since ASCT or start of first-line treatment | n = 19 | ORR, 100% CR or better rates, 90% MRD rates (10−5), 74% 18-mo PFS, 83% 18-mo OS, 83% |
| Clinical trial . | Study design . | Definition of FHR . | Patients . | Clinical outcomes . |
|---|---|---|---|---|
| KarMMA-2, cohort 2a55 | Ide-cel | ER: progressive disease within 18 months from first-line treatment including induction, ASCT, and lenalidomide maintenance | n = 37 | ORR, 84% CR rate 46% PFS, median 11.4 mo 2-y OS, 85% DOR, median • Overall population, 16 mo • Patients in CR, 24 mo |
| KarMMA-2, cohort 2c57 | Ide-cel | Inadequate response (less than VGPR) after up-front ASCT | n = 31 | ORR, 87% CR rate, 74% MRD rates (10−5), 42% |
| CARTITUDE 2, cohort b56 | Cilta-cel | ER: progressive disease after initial therapy including PIs and IMiDs within 12 months since ASCT or start of first-line treatment | n = 19 | ORR, 100% CR or better rates, 90% MRD rates (10−5), 74% 18-mo PFS, 83% 18-mo OS, 83% |
CR, complete response; DOR, duration of response; ER, early relapse; ORR, overall response rate.