Rapid anti-myeloma activity by T cells expressing an anti-BCMA CAR with a human heavy-chain-only antigen-binding domain
Open accessAbstract
Multiple myeloma (MM) is a rarely curable malignancy of plasma cells. MM expresses B cell maturation antigen (BCMA). We developed a fully human anti-BCMA chimeric antigen receptor (CAR) with a heavy-chain-only antigen-recognition domain, a 4-1BB domain, and a CD3ζ domain. The CAR was designated FHVH33-CD8BBZ. We conducted the first-in-humans clinical trial of T cells expressing FHVH33-CD8BBZ (FHVH-T). Twenty-five patients with relapsed MM were treated. The stringent complete response rate (sCR) was 52%. Median progression-free survival (PFS) was 78 weeks. Of 24 evaluable patients, 6 (25%) had a maximum cytokine-release syndrome (CRS) grade of 3; no patients had CRS of greater than grade 3. Most anti-MM activity occurred within 2–4 weeks of FHVH-T infusion as shown by decreases in the rapidly changing MM markers serum free light chains, urine light chains, and bone marrow plasma cells. Blood CAR + cell levels peaked during the time that MM elimination was occurring, between 7 and 15 days after FHVH-T infusion. C-C chemokine receptor type 7 (CCR7) expression on infusion CD4 + FHVH-T correlated with peak blood FHVH-T levels. Single-cell RNA sequencing revealed a shift toward more differentiated FHVH-T after infusion. Anti-CAR antibody responses were detected in 4 of 12 patients assessed. FHVH-T has powerful, rapid, and durable anti-MM activity.
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The overall PFS with FHVH33-CD8BBZ was 78 weeks.
“Results indicated that 92% (23/25) patients achieved an objective response, 68% (17/25) of patients attained sCR or VGPR, and the overall PFS was 78 weeks, indicating a durable response to treatment.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [249]
In 25 patients with relapsed MM, 92% (23/25) achieved an objective response to FHVH33-CD8BBZ, and 68% (17/25) attained sCR or VGPR.
“Results indicated that 92% (23/25) patients achieved an objective response, 68% (17/25) of patients attained sCR or VGPR, and the overall PFS was 78 weeks, indicating a durable response to treatment.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [249]
25% of patients experienced a maximum CRS grade of 3 with FHVH33-CD8BBZ, and no patients had CRS greater than grade 3.
“25% of patients experienced a maximum CRS grade of 3, and no patients had CRS greater than grade 3 [248, 249].”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [249]
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Flagged first, then by citations
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Sorted by citations
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Self-citation
- Authors
- Mikkilineni, L., Natrakul, D. A., Lam, N., Manasanch, E. E., Mann, J., Weissler, K. A., Wong, N., Brudno, J. N., Goff, S. L., Yang, J. C., Ganaden, M., Patel, R., Zheng, Z., Gartner, J. J., Martin, K. R., Wang, H.-W., Yuan, C. M., Lowe, T., Maric, I., Shao, L., Jin, P., Stroncek, D. F., Highfill, S. L., Rosenberg, S. A., & Kochenderfer, J. N.
- Affiliations
- National Institutes of Health (US)
- The University of Texas MD Anderson Cancer Center (US)
- Frederick National Laboratory for Cancer Research (US)
- Corresponding author
- Kochenderfer, James N.
- ORCID
- Venue
- Molecular Therapy
- Publisher
- Elsevier BV
- Published
- 2024-02
- Volume
- 32
- Issue
- 2
- Pages
- 503-526
- ISSN
- 1525-0016 (ISSN-L)
- PMC
- PMC10861980
- OpenAlex
- W4390350110
- Cited by
- 16
- References
- 102
- Citations by year
- 2026: 6 · 2025: 4 · 2024: 6
- FWCI
- 1.95
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Molecular Therapy (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Digital Commons-TMC (Texas Medical Center) (submittedVersion)
- Funders
- National Institutes of Health
- U.S. Department of Health and Human Services
- National Cancer Institute (ZIABC011439-11)
- Bristol-Myers Squibb
- Center for Cancer Research (HHSN261201500003I)
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Keywords
- BCMA, chimeric antigen receptor T cells, multiple myeloma, T cell differentiation, CAR T-cell therapy
- MeSH terms
- Receptors, Chimeric Antigen, Bone Marrow, Humans, Multiple Myeloma, T-Lymphocytes, Immunotherapy, Adoptive
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