On November 2, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will have two poster presentations focused on the importance of lymphodepletion in allogeneic cell therapy at the 65th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) taking place December 9-12, 2023 in San Diego, CA (Press release, Allogene, NOV 2, 2023, View Source [SID1234636726]).
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"All CAR T cells require lymphodepletion to support the expansion and persistence needed to eradicate malignant cells. Because of the risk of allorejection by the patient’s immune system, creating the necessary window of persistence for an off-the-shelf, allogeneic CAR T product may require an enhanced approach to lymphodepletion. These results reinforce our belief that Allogene’s strategy of adding ALLO-647, an anti-CD52 monoclonal antibody candidate, to the standard fludarabine/cyclophosphamide (flu/cy) lymphodepletion regimen in our ALPHA/ALPHA2 studies can safely achieve this," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "Our unique and proprietary lymphodepletion regimen that includes ALLO-647 has been shown to potentially induce deep and durable remissions in relapsed and treatment-refractory cancers."
The first poster is a comprehensive safety review of all 85 patients treated in the Phase 1 ALPHA/ALPHA2 studies in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL) to characterize the overall safety profile when ALLO-647 is added to standard lymphodepletion.
In June 2023 at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, the Company presented updated data from the Phase 1 ALPHA/ALPHA2 trials of investigational ALLO-501/501A in 33 CAR T naïve patients with r/r LBCL treated with the Alloy manufacturing process material across different CAR T dosing and lymphodepletion regimens. Data from the 12 patients, a subset of these 33 CAR T naïve patients, who received the regimen being utilized in ongoing Phase 2 trials was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data demonstrated that administration of the anti-CD19 allogeneic CAR T product candidate following a 3-day lymphodepletion regimen that includes fludarabine 30 mg/m2 and cyclophosphamide 300-500 mg/m2 (FC) and 39, 60, or 90 mg of ALLO-647 in divided doses can potentially yield durable responses and an acceptable safety profile in line with approved autologous CAR T therapies.
Title: ALLO-647 for Lymphodepletion in the Allogeneic CAR T Setting: Safety Experience with ALLO-501/501A in Patients (Pts) with Relapsed/Refractory (r/r) Large B-Cell and Follicular Lymphomas
Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Abstract: 2095
Presenter: Dr. Frederick Locke, M.D., Chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy; program co-leader, Immuno-Oncology, Moffitt Cancer Center
Tampa, Florida
Session Date & Time: Saturday, December 9, 2023, 5:30 PM – 7:30 PM PT
Location: San Diego Convention Center, Halls G-H
The second poster showcases translational results from ALPHA2 generated through a collaboration with researchers from The University of Texas MD Anderson Cancer Center. This study compared expansion kinetics among 11 allogeneic CAR T recipients treated with investigational ALLO-501A in the ALPHA2 trial. The study revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection. Results of this study could help define strategies to improve allogeneic CAR T expansion, persistence, and efficacy.
Title: Cellular Mechanisms Affecting Allogeneic CAR T Cell Expansion and Rejection in Large B-cell Lymphoma
Session: 703. Cellular Immunotherapies: Basic and Translational: Poster III
Abstract: #4832
Presenter: Andrew P. Jallouk, M.D., Ph.D,Vanderbilt / MD Anderson
Session Date & Time: Monday, December 11, 2023 6:00pm – 8:00pm PT
Location: San Diego Convention Center, Halls G-H
About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.