Table 4 Universal/Off-the shelf CAR-T and CAR-NK studies.
From: CAR-T cell therapy in Multiple Myeloma: current status and future challenges
Study | CAR-T | Study design | Patients | Outcomes |
|---|---|---|---|---|
NCT04093596 Phase 1 UNIVERSAL | ALLO-715 TCR alpha and CD52 genes disrupted with TALEN | Various lymphodepletion regimens including use of ALLO-647 (anti-CD52 monoclonal antibody) ALLO-715 40, 160, 320, 480 × 106 CAR-T | N = 43 ≥ 3 Prior lines of therapy including PI/IMiD/anti-CD38 | Among patients treated with 320 × 106 CAR-T (n = 24), ORR 71%, ≥CR 25% CRS 56% (≥ Grade 3 2%), neurotoxicity 14% (all Grade 1/2) |
NCT04613557 Phase 1 IMMUNICY-1 | CYAD-211 CAR-T co-expresses shRNA targeting CD32 to reduce surface TCR expression | Fludarabine 30 mg/m2, cyclophosphamide 300 mg/m2 days -5 to -3 30, 100, 300 × 106 CAR-T | N = 9 ≥ 2 Prior lines of therapy, median 4 prior lines | 8 patients evaluable for responses, 2 PRs (25%) 1 patient had Grade 1 CRS (11%) |
NCT04960579 Phase 1 P-BCMA-ALLO1 | P-BCMA-ALLO1 piggyBac system used to knock out TCR beta chain 1 and beta-2-microglobulin | Various lymphodepletion regimens P-BCMA-ALLO1 0.0625-15 × 106 cells/kg | N = 24 Triple class-exposed RRMM Median 7 prior lines, 30% previous BCMA-directed therapy | CRS 14% (grade 1), ICANS 4% (1 patient, grade 1), no GvHD |
NCT05182073 Phase 1 | FT576 BCMA CAR-NK | FT576 1 or 3 × 106 cells±Daratumumab Fludarabine and cyclophosphamide lymphoma depletion | N = 9 ≥ 3 Prior lines of therapy including PI/IMiD/anti-CD38 | No DLTs CRS 0%, neurotoxicity 0%, GvHD 0% |
