Table 6.
Selected preclinical and clinical trials of universal CAR-T, CAR-NK products, and iPSC-derived immunotherapy at the 2021 ASH annual meeting
| Clinical trials (reference) | Abstract 649 ALLO-501A [94] |
Abstract 302 PBCAR0191 [95] |
Abstract 651 ALLO-715 [115] |
Abstract 823 FT596 [103] |
Abstract 1766 FT819 [100] |
|---|---|---|---|---|---|
| Study type | Single-arm, open-label, Phase 1/2 clinical trial (ALPHA2 Study, NCT04416984) | Phase 1/2 clinical trial | Open-label, Phase 1 trial (UNIVERSAL, NCT04093596) | Multicenter, Phase 1 clinical trial (NCT04245722) |
Preclinical ongoing Phase 1 |
| Target | CD19 | CD19 | BCMA | CD19 | CD19 |
| Cell source | Allogenic T cells | Allogenic T cells | Allogenic T cells | iPSC-derived NK cells | iPSC-derived T cells |
| Disease | R/R large B-cell lymphoma | CD19+ R/R B-ALL or NHL | R/R multiple myeloma | R/R B-cell lymphoma | B-cell malignancies |
| Innovation | TALEN® gene editing to disrupt TRAC and CD52 gene | CD19 CAR is knocked-into TRAC locus after editing with a TRAC-specific ARCUS nuclease | TALEN® gene editing to disrupt TRAC and CD52 gene | High-affinity, non-cleavable CD16 Fc receptor and IL-15/IL-15 receptor fusion | 1XX anti-CD19 CAR is inserted under the regulation of TRAC locus |
| Patient (n) | 15 |
16 NHL 5 B-ALL |
42 | 20 | NA |
|
Response rate (ORR/CR) |
ORR: 50% CR: 50% |
NHL: ORR 85%; CR/CRi 62% B-ALL: ORR:80%; CR/CRi 80% |
ORR: 61.5% VGPR + : 38.5% |
ORR of whole cohort: 52.9%; single-dose levels of ≥ 90 million cells: ORR: 72.7%; CR: 63.6% |
NA |
| CRS, any grade | 0 | NA | 52.4% | 10% | NA |
| ICANS, any grade | 0 | 4.8% | 2.4% | 0 | NA |
| GvHD | 0 | 0 | NA | 0 | NA |
NA not applicable