Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results

Mailankody, Sham; Matous, Jeffrey V.; Chhabra, Saurabh; Liedtke, Michaela; Sidana, Surbhi; Oluwole, Olalekan O.; Malik, Shahbaz; Nath, Rajneesh; Anwer, Faiz; Cruz, Jose Carlos; Htut, Myo; Karski, Erin E.; Lovelace, Wade; Dillon, Myles; Butz, Eric; Ying, Wendy; Balakumaran, Arun; Kumar, Shaji K.

doi:10.1038/s41591-022-02182-7

Cited by 257CAR-T cell therapy researchMultiple Myeloma Research and TreatmentsImmunotherapy and Immune Responses

Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results

Mailankody, Sham, Matous, Jeffrey V., Chhabra, Saurabh, Liedtke, Michaela, Sidana, Surbhi, Oluwole, Olalekan O., Malik, Shahbaz, Nath, Rajneesh +10 more·2023·Nature Medicine

DOI 10.1038/s41591-022-02182-7

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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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In the phase 1 study of ALLO-715, the ORR was 70.8%, with VGPR in 45.8% and CR or sCR in 25% of patients.
“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]
Adverse events with ALLO-715 included CRS in 55.8%, neurotoxicity in 14%, and infections in 53.5% of patients.
“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]
The median DOR with ALLO-715 was 8.3 months.
“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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Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
(2019) · Case Medical Research · doi:10.31525/ct1-nct04093596

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: Mailankody, Sham
Chhabra, Saurabh
Liedtke, Michaela
Sidana, Surbhi
Oluwole, Olalekan O.
Malik, Shahbaz
Nath, Rajneesh
Anwer, Faiz
Htut, Myo
Ying, Wendy
Kumar, Shaji K.
Venue: Nature Medicine
Publisher: Springer Science and Business Media LLC
Published: 2023-01-23
Volume: 29
Issue: 2
Pages: 422-429
ISSN: 1078-8956 (ISSN-L)
1546-170X
DOI: 10.1038/s41591-022-02182-7
OpenAlex: W4317802192
Cited by: 257
References: 31
Citations by year: 2026: 42 · 2025: 57 · 2024: 96 · 2023: 60 · 2013: 1
FWCI: 31.02
Type: journal article
Language: en
Update notices: correction (2023-03-17)
Open access: closed
Licence: www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
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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Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results

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