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Phase I trial on the efficacy and safety of P-BCMA-ALLO1 CAR T-cell therapy in RRMM
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An open-label, phase I trial (NCT04960579) assessed the safety and efficacy of P-BCMA-ALLO1, a non-viral, allogeneic BCMA-directed CAR T-cell therapy, in 72 heavily-pretreated patients with RRMM.1 Patients received either P-BCMA-ALLO1 0.25–6 × 106 cells/kg in Arm S (n = 25) or 2 × 106 cells/kg in each Arms A (n = 19), B (n = 10), and C (n = 23). Lymphodepletion consisted of fludarabine 30 mg/m2 plus cyclophosphamide 300 mg/m2, 500 mg/m2, 1000 mg/m2, or 750 mg/m2 in Arms S, A, B, and C, respectively.1 In total, 69% of patients had high-risk cytogenetics and 43% of patients had prior anti-BCMA/talquetamab therapy. Interim results from this trial were presented at the 21st IMS Annual Meeting by Dholaria.1 |
| Key learnings |
| The ORR in Arms S, A, B, and C were 21%, 42%, 70%, and 91%, respectively; the higher response rates were observed in patients who received higher lymphodepletion. |
| In Arm C, BCMA-naïve patients (n = 9), patients with ≥1 prior BCMA therapy (n = 14), and patients with ≥1 prior BCMA and talquetamab therapy (n = 7), achieved an ORR of 100%, 86%, and 86%, respectively. |
| Treatment was well tolerated, with no DLTs, Grade ≥3 CRS/ICANS, GvHD, HLH/MAS, Parkinsonism, or cranial neuropathies observed. Grade ≤2 CRS and neurotoxicity were reported in 27% and 7% of patients, respectively. |
| Grade ≥3 infection occurred in 13% of patients. Cytopenias were experienced by most patients; however, 82% of patients achieved rapid recovery to Grade ≤2 cytopenia by Day 30. |
| Results from this trial suggested that P-BCMA-ALLO1 is well tolerated with promising clinical activity in heavily pretreated patients with RRMM. The study is ongoing, with the phase Ib part utilizing the Arm C dose and lymphodepletion. |
Abbreviations: BCMA, B-cell maturation agent; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; DLT, dose-limiting toxicity; GvHD, graft-versus-host disease; HLH, hemophagocytic lymphohistiocytosis; ICANS, immune effector cell-associated neurotoxicity syndrome; IMS, International Myeloma Society; MAS, macrophage activation syndrome; RRMM, relapsed/refractory multiple myeloma.
- Dholaria BR. A phase 1 study of P-BCMA-ALLO1, a non-viral, allogeneic BCMA directed CAR-T in relapsed/refractory multiple myeloma (RRMM). Oral abstract #OA–04. Presented at: 21st International Myeloma Society Annual Meeting; Sep 25–28, 2024; Rio de Janeiro, BR.
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