- ALLO-715, an Allogeneic BCMA CAR T Therapy Dosed with an ALLO-647 Based Lymphodepletion Regimen, Reported No Neurotoxicity or GvHD Across Three Cell Doses (40M, 120M, and 320M CAR+ cells) and Lower Dose (39mg) ALLO-647
- Dose Dependent Activity Was Observed with 320M Cell Dose of ALLO-715 (DL3) Associated with a 60% Overall Response Rate (ORR)
- All DL3 Patients with a VGPR or Greater Achieved MRD Negative Status
- Results from Additional Patients, Including Patients Treated at Higher Doses of ALLO-715 and ALLO-647 Will Be Presented on December 5, 2020
- Study Continues Enrollment to Optimize Dosing and Lymphodepletion
- Preclinical Data Will Also be Presented on ALLO-605, a BCMA TurboCAR T™ Cell Therapy and ALLO-316 Targeting CD70 in Acute Myeloid Leukemia
The initial data from its Phase 1 UNIVERSAL trial of ALLO-715, in relapsed/refractory multiple myeloma in 15 evaluable patients, higher dose of ALLO-715 (DL3) achieved greater activity with 60% (3/5) patients responding (95% CI 14.7, 94.7). Of the three patients who received DL3 FCA, two responded (1 stringent complete response (sCR) and 1 very good partial response (VGPR)) and both were minimum residual disease (MRD) negative by local MRD testing.
| LD Regimen and Cell Dose | FCA | CA | Overall DL3 (95% CI) (N=5) | |||
| DL1 40 x 106 CAR+cells (N=3) | DL2 160 x 106 CAR+cells (N=4) | DL3 320 x 106 CAR+cells (N=3) | DL2 160 x 106 CAR+cells (N=3) | DL3 320 x 106 CAR+cells (N=2) | ||
| ORR, n (%) | 0 (0%) | 2 (50%) | 2 (66%) | 0 (0%) | 1(50%) | 3/5 (60%) (14.7, 94.7) |
At the time of the data cutoff, 17 of the patients were evaluable for safety. No neurotoxicity or graft-vs-host disease (GvHD) was observed. Cytokine release syndrome (CRS) was reported in four patients (24%) with three Grade 1 and one Grade 2. All CRS was resolved without tocilizumab or corticosteroids. The most common Grade ≥ 3 adverse events were anemia (41.2%), neutropenia (41.2%), lymphopenia (29.4%), and thrombocytopenia (29.4%).
Four (23.5%) instances of Grade ≥ 3 infections were observed. Three of these were Grade 3 and resolved with treatment. The fourth was a Grade 5 event of suspected fungal pneumonia that occurred on day eight post-ALLO-715 infusion. The suspected fungal pneumonia was diagnosed on the day after cell infusion in this patient with advanced and rapidly progressing disease who had failed multiple lines of therapy. This event occurred in the CA cohort, and it was assessed by the investigator as related to progressive disease and the CA conditioning.
Details for the oral Presentation:
Session: 653. Myeloma/Amyloidosis: Therapy, Excluding Transplantation; CAR T Therapies for Myeloma: Novel Approaches and Longer-Term Follow Up Data
Abstract #129
Title: Universal: An Allogeneic First-in-Human Study of the Anti-BCMA ALLO-715 and the Anti-CD52 ALLO-647 in Relapsed/Refractory Multiple Myeloma
Presenter: Sham Mailankody, M.D., Memorial Sloan Kettering Cancer Center
Session Date & Time: Saturday, December 5, 2020; 9:30 a.m. – 11 a.m. PT
Preclinical findings from investigations of ALLO-316, an AlloCAR T targeting CD70 in acute myeloid leukemia and ALLO-605, a BCMA-directed TurboCAR TTM cell therapy in multiple myeloma, will also be presented in poster sessions.
Allogene Poster Presentations
Session: 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Poster II
Abstract #1972
Title: Investigation of ALLO-316: A Fratricide-Resistant Allogeneic CAR T Targeting CD70 As a Potential Therapy for the Treatment of AML
Presenter: Nguyen Tan, Allogene Therapeutics
Session Date & Time: Sunday, December 6, 2020; 7 a.m. – 3:30 p.m. PT
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster III
Abstract #3258
Title: Preclinical Evaluation of ALLO-605, an Allogeneic BCMA TurboCAR TTMCell Therapy for the Treatment of Multiple Myeloma
Presenter: Cesar Sommer, Ph.D., Allogene Therapeutics
Session Date & Time: Monday, December 7, 2020; 7 a.m. – 3 p.m. PT