Summary of ongoing studies evaluating CAR T cell therapy in earlier lines of therapy or in combinations with standard of care treatment
| Trial . | Study population . | Study design . | CAR name . | ScFv origin . | Phase . | n . | Antigen . | Cell source . | End point . | Dose . | Status . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| FUMANBA-2 (NCT05181501) | NDMM high-risk | VRD/PAD/PCD × 3-ASCT (if eligible) >> CT103A | CT103A | Human | 1 | 20 | BCMA | Autologous | MRD negativity 2-year PFS | 1 × 106/kg | Not yet enrolling |
| NCT04287660 | NDMM | BiRD + BCMA CAR T cell | NA | NA | 3 | 20 | BCMA | Autologous | ORR at 4 weeks | 2-3 × 107/kg | Recruiting |
| CARTITUDE-5 NCT04923893 | NDMM not intended for ASCT | A: VRD × 8 + Rd B: VRD (6 + 2) + cilta-cel | Cilta-cel | Llama | 3 randomized | 650 | BCMA | Autologous | PFS | 0.75 × 106/kg | Recruiting |
| NCT04935580 | NDMM-TE high-risk | 2 cycles induction + CAR T + Len maintenance | GC012F | Human | 1/2 | 20 | BCMA- CD19 | Autologous | Safety ORR, PFS, MRD | 3 × 105/kg | Recruiting |
| CARTITUDE-6 NCT05257083 | NDMM TE | A: DVRD × 4 + ASCT +2 × DVRD + Len B: DVRD × 6 + cilta-cel + Len (2 y) | Cilta-cel | Llama | 3 randomized | 750 | BCMA | Autologous | PFS | 0.75 × 106/kg | Not yet enrolling |
| KarMMa-4 NCT04196491 | NDMM high-risk (R-ISS 3) | Standard induction × 3 cycles + Ide-cel | Ide-cel | Murine | 1 | 13 | BCMA | Autologous | Safety | 450 × 106 | Active Not recruiting |
| CARTITUDE-2 NCT04133636 | Multicohort | Cohort A: 1-3 prior lines Len-ref Cohort B: early relapse after frontline treatment Cohort C: relapse after BCMA Cohort F: NDMM after frontline Cohort E: NDMM-Tx not planned (high-risk) | Cilta-cel | Llama | 2 | 157 | BCMA | Autologous | MRD negativity at 1 year | 0.75 × 106/kg | Recruiting |
| KarMMa-2 NCT03601078 | Multicohort | 2a + b: R-ISS 3 + early relapse 2c: suboptimal response to ASCT | Ide-cel | Murine | 2 | 181 | BCMA | Autologous | ORR | 150-450 × 106 | Recruiting |
| KarMMa-7 NCT04855136 | 1-3 PL + Len R ≥3 PL RRMM | (A): Ide-cel + iberdomide maintenance (B): Ide-cel + gamma secretase inhibitor | Ide-cel | Murine | 2 | 181 | BCMA | Autologous | ORR | 150-450 × 106 | Recruiting |
| KarMMa-3 NCT03651128 | 2-4 prior lines Len-ref & anti-CD38 exposed | A: DVd/DPd/EloPd/Ixa-Rd/Kd B: Ide-cel | Ide-cel | Murine | 3 Randomized | 381 | BCMA | Autologous | PFS | 450 × 106 | Recruiting |
| CARTITUDE-4 NCT04181827 | 1-3 prior lines Len refractory | A: PVd or DPd B: cilta-cel | Cilta-cel | Llama | 3 randomized | 419 | BCMA | Autologous | PFS | 0.75 × 106/kg | Active Not recruiting |
| BMTCTN1902 NCT05032820 | NDMM post-ASCT | Ide-cel + Len maintenance | Ide-cel | Murine | 2 | 40 | BCMA | Autologous | ORR | 450 × 106 | Recruiting |
| Trial . | Study population . | Study design . | CAR name . | ScFv origin . | Phase . | n . | Antigen . | Cell source . | End point . | Dose . | Status . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| FUMANBA-2 (NCT05181501) | NDMM high-risk | VRD/PAD/PCD × 3-ASCT (if eligible) >> CT103A | CT103A | Human | 1 | 20 | BCMA | Autologous | MRD negativity 2-year PFS | 1 × 106/kg | Not yet enrolling |
| NCT04287660 | NDMM | BiRD + BCMA CAR T cell | NA | NA | 3 | 20 | BCMA | Autologous | ORR at 4 weeks | 2-3 × 107/kg | Recruiting |
| CARTITUDE-5 NCT04923893 | NDMM not intended for ASCT | A: VRD × 8 + Rd B: VRD (6 + 2) + cilta-cel | Cilta-cel | Llama | 3 randomized | 650 | BCMA | Autologous | PFS | 0.75 × 106/kg | Recruiting |
| NCT04935580 | NDMM-TE high-risk | 2 cycles induction + CAR T + Len maintenance | GC012F | Human | 1/2 | 20 | BCMA- CD19 | Autologous | Safety ORR, PFS, MRD | 3 × 105/kg | Recruiting |
| CARTITUDE-6 NCT05257083 | NDMM TE | A: DVRD × 4 + ASCT +2 × DVRD + Len B: DVRD × 6 + cilta-cel + Len (2 y) | Cilta-cel | Llama | 3 randomized | 750 | BCMA | Autologous | PFS | 0.75 × 106/kg | Not yet enrolling |
| KarMMa-4 NCT04196491 | NDMM high-risk (R-ISS 3) | Standard induction × 3 cycles + Ide-cel | Ide-cel | Murine | 1 | 13 | BCMA | Autologous | Safety | 450 × 106 | Active Not recruiting |
| CARTITUDE-2 NCT04133636 | Multicohort | Cohort A: 1-3 prior lines Len-ref Cohort B: early relapse after frontline treatment Cohort C: relapse after BCMA Cohort F: NDMM after frontline Cohort E: NDMM-Tx not planned (high-risk) | Cilta-cel | Llama | 2 | 157 | BCMA | Autologous | MRD negativity at 1 year | 0.75 × 106/kg | Recruiting |
| KarMMa-2 NCT03601078 | Multicohort | 2a + b: R-ISS 3 + early relapse 2c: suboptimal response to ASCT | Ide-cel | Murine | 2 | 181 | BCMA | Autologous | ORR | 150-450 × 106 | Recruiting |
| KarMMa-7 NCT04855136 | 1-3 PL + Len R ≥3 PL RRMM | (A): Ide-cel + iberdomide maintenance (B): Ide-cel + gamma secretase inhibitor | Ide-cel | Murine | 2 | 181 | BCMA | Autologous | ORR | 150-450 × 106 | Recruiting |
| KarMMa-3 NCT03651128 | 2-4 prior lines Len-ref & anti-CD38 exposed | A: DVd/DPd/EloPd/Ixa-Rd/Kd B: Ide-cel | Ide-cel | Murine | 3 Randomized | 381 | BCMA | Autologous | PFS | 450 × 106 | Recruiting |
| CARTITUDE-4 NCT04181827 | 1-3 prior lines Len refractory | A: PVd or DPd B: cilta-cel | Cilta-cel | Llama | 3 randomized | 419 | BCMA | Autologous | PFS | 0.75 × 106/kg | Active Not recruiting |
| BMTCTN1902 NCT05032820 | NDMM post-ASCT | Ide-cel + Len maintenance | Ide-cel | Murine | 2 | 40 | BCMA | Autologous | ORR | 450 × 106 | Recruiting |
ASCT, autologous stem cell transplantation; BiRD, bortezomib, claritromicine, lenalidomide, dexamethasone; DPd, daratumumab, pomalidomide, dexamethasone; DVd, daratumumab, bortezomib, dexamethasone; EloPd, elotuzumab, pomalidomide, dexamethasone; IxaRd, izaxomib, lenalidomide, dexamethasone; Kd, carfilzomib, dexamethasone; Len, lenalidomide; Len-ref, lenalidomide refractory; NA, not available; NDMM, newly diagnosed multiple myeloma; NDMM-TE, newly diagnosed transplant eligible; PAD, bortezomib, adryamicine, dexamethasone; PCD, bortezomib, cyclophosphamide, dexamethasone; PVd, pomalidomide, bortezomib, dexamethasone; Rd, lenalidomide-dexamethasone; Tx, transplant.