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Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results
Abstract
ALLO-715 is a first-in-class, allogeneic, anti-BCMA CAR T cell therapy engineered to abrogate graft-versus-host disease and minimize CAR T rejection. We evaluated escalating doses of ALLO-715 after lymphodepletion with an anti-CD52 antibody (ALLO-647)-containing regimen in 43 patients with relapsed/refractory multiple myeloma as part A of the ongoing first-in-human phase 1 UNIVERSAL trial. Primary objectives included determination of the safety and tolerability of ALLO-715 and the safety profile of the ALLO-647-containing lymphodepletion regimen. Key secondary endpoints were response rate and duration of response. Grade ≥3 adverse events were reported in 38 (88.0%) of patients. Cytokine release syndrome was observed in 24 patients (55.8%), with 1 grade ≥3 event (2.3%) and neurotoxicity in 6 patients (14%), with no grade ≥3 events. Infections occurred in 23 patients (53.5%), with 10 (23.3%) of grade ≥3. Overall, 24 patients (55.8%) had a response. Among patients treated with 320 × 10 6 CAR+ T cells and a fludarabine-, cyclophosphamide- and ALLO-647-based lymphodepletion regimen (n = 24), 17 (70.8%) had a response including 11 (45.8%) with very good partial response or better and 6 (25%) with a complete response/stringent complete response. The median duration of response was 8.3 months. These initial results support the feasibility and safety of allogeneic CAR T cell therapy for myeloma.
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“The ORR was 70.8%, with VGPR in 45.8% of patients and the CR or sCR in 25% of patients.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [252]
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“Adverse events included CRS in 55.8% of patients, neurotoxicity in 14% of patients, and infections in 53.5% of patients.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [252]
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“The median DOR was 8.3 months.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [252]
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Metadata
- Authors
- Mailankody, S., Matous, J. V., Chhabra, S., Liedtke, M., Sidana, S., Oluwole, O. O., Malik, S., Nath, R., Anwer, F., Cruz, J. C., Htut, M., Karski, E. E., Lovelace, W., Dillon, M., Butz, E., Ying, W., Balakumaran, A., & Kumar, S. K.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Colorado Blood Cancer Institute (US)
- Medical College of Wisconsin (US)
- Stanford Medicine (US)
- Vanderbilt University Medical Center (US)
- St David's Medical Center (US)
- Banner MD Anderson Cancer Center (US)
- Cleveland Clinic (US)
- City Of Hope National Medical Center (US)
- Allogene Therapeutics (United States) (US)
- Mayo Clinic (US)
- Corresponding author
- Mailankody, Sham
- ORCID
- Venue
- Nature Medicine
- Published
- 2023-01-23
- Volume
- 29
- Issue
- 2
- Pages
- 422-429
- ISSN
- 1078-8956 (ISSN-L)
- 1546-170X
- OpenAlex
- W4317802192
- Cited by
- 257
- References
- 31
- Citations by year
- 2026: 42 · 2025: 57 · 2024: 96 · 2023: 60
- FWCI
- 31.02
- Type
- journal article
- Language
- en
- Update notices
- correction (2023-03-17)
- Open access
- closed
- Licence
- Locations
- Nature Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (P30CA008748)
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- allogeneic CAR T cells, BCMA, multiple myeloma, relapsed/refractory multiple myeloma, anti-CD52 antibody, lymphocyte depletion, graft-versus-host disease prophylaxis, cytokine release syndrome, neurotoxicity, safety and tolerability, response rate, duration of response
- MeSH terms
- Cyclophosphamide, Humans, Multiple Myeloma, T-Lymphocytes, Immunotherapy, Adoptive, Hematopoietic Stem Cell Transplantation
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