Anti-BCMA CAR T-cell therapy bb2121 in relapsed or refractory multiple myeloma.
Open accessAbstract
BACKGROUNDPreclinical studies suggest that bb2121, a chimeric antigen receptor (CAR) T-cell therapy that targets B-cell maturation antigen (BCMA), has potential for the treatment of multiple myeloma. METHODSIn this phase 1 study involving patients with relapsed or refractory multiple myeloma, we administered bb2121 as a single infusion at doses of 50×10 6 , 150×10 6 , 450×10 6 , or 800×10 6 CAR-positive (CAR+) T cells in the dose-escalation phase and 150×10 6 to 450×10 6 CAR+ T cells in the expansion phase.Patients had received at least three previous lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or were refractory to both drug classes.The primary end point was safety. RESULTSResults for the first 33 consecutive patients who received a bb2121 infusion are reported.The data-cutoff date was 6.2 months after the last infusion date.Hematologic toxic effects were the most common events of grade 3 or higher, including neutropenia (in 85% of the patients), leukopenia (in 58%), anemia (in 45%), and thrombocytopenia (in 45%).A total of 25 patients (76%) had cytokine release syndrome, which was of grade 1 or 2 in 23 patients (70%) and grade 3 in 2 patients (6%).Neurologic toxic effects occurred in 14 patients (42%) and were of grade 1 or 2 in 13 patients (39%).One patient (3%) had a reversible grade 4 neurologic toxic effect.The objective response rate was 85%, including 15 patients (45%) with complete responses.Six of the 15 patients who had a complete response have had a relapse.The median progression-free survival was 11.8 months (95% confidence interval, 6.2 to 17.8).All 16 patients who had a response (partial response or better) and who could be evaluated for minimal residual disease (MRD) had MRD-negative status (≤10 -4 nucleated cells).CAR T-cell expansion was associated with responses, and CAR T cells persisted up to 1 year after the infusion. CONCLUSIONSWe report the initial toxicity profile of a BCMA-directed cellular immunotherapy for patients with relapsed or refractory multiple myeloma.Antitumor activity was documented.
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Ide-cel safety profile remained consistent with prior reports, with no new safety signals, no additional CRS or iiNT events, and no parkinsonism, Guillain-Barré syndrome, or SPMs of T-cell origin reported.
“Safety of ide-cel remained consistent with the IA, with no parkinsonism, Guillain-Barré syndrome, or SPMs of T-cell origin reported. 13”
From Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. (2024) · cites this paper as [19]
The Results > Safety section reports adverse events, cytokine release syndrome, and neurologic toxic effects in the initial bb2121 study; the Discussion describes its safety profile as favorable. Our copy does not compare a later safety assessment with an interim analysis or report whether parkinsonism, Guillain-Barré syndrome, or T-cell–origin second primary malignancies were absent. (LLM, conf=0.76)
Experimental — accuracy not yet measuredObserved toxic effects were consistent with those in previous reports.
“Observed toxic effects were consistent with those in previous reports.11”
From Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. (2021) · cites this paper as [11]
The Results (Safety; page unavailable) document the observed toxic effects. The Discussion compares them with previous studies, but reports a lower incidence of severe cytokine release syndrome with bb2121 and cautions that cross-study comparisons are complicated. It does not establish that the toxic effects were generally consistent with previous reports. (LLM, conf=0.82)
Experimental — accuracy not yet measuredChimeric antigen receptor T-cell therapy has shown promising efficacy in patients with triple-class-exposed relapsed and refractory multiple myeloma.
“Chimeric antigen receptor (CAR) T-cell therapy has shown promising ef fi cacy in patients with TCE R/RMM. 13-21”
From Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. (2024) · cites this paper as [19]
The BCMA-directed CAR T cell ide-cel showed promising efficacy in a phase 1 study involving patients with relapsed or refractory myeloma.
“The B-cell maturation antigen (BCMA)-directed CAR T cell idecabtagene vicleucel (ide-cel, also called bb2121) showed promising efficacy in a phase 1 study involving patients with relapsed or refractory myeloma.11”
From Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. (2021) · cites this paper as [11]
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“Therapeutic approaches such as chimeric antigen receptor T-cell therapies and bispecific T-cell engagers that use T cell–mediated cytotoxicity to target BCMA on plasma cells have shown deep responses in patients with relapsed or refractory disease.(21-25) Another class of T-cell redirecting therapy in development for…”
BackgroundTreatment options for triple-class refractory multiple myeloma.
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- Authors
- Raje, N., Berdeja, J., Lin, Y., Siegel, D., Jagannath, S., Madduri, D., Liedtke, M., Rosenblatt, J., Maus, M. V., Turka, A., Lam, L.-P., Morgan, R. A., Friedman, K., Massaro, M., Wang, J., Russotti, G., Yang, Z., Campbell, T., Hege, K., Petrocca, F., Quigley, M. T., Munshi, N., & Kochenderfer, J. N.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- From the Massachusetts General Hospital Cancer Center (N.R., M.V.M.), Beth Israel Deaconess Medical Center (J.R.), and Dana–Farber Cancer Institute and Veterans Affairs Boston Healthcare System (N.M.), Boston, and Bluebird Bio, Cambridge (A.T., L.-P.L., R.A.M., K.F., M.M., F.P., M.T.Q.) — all in Massachusetts; Sarah Cannon Research Institute and Tennessee Oncology, Nashville (J.B.); Mayo Clinic, Rochester, MN (Y.L.); Hackensack University Medical Center, Hackensack (D.S.), and Celgene, Summit (J.W.,...
- National Institutes of Health (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-05-02
- Volume
- 380
- Issue
- 18
- Pages
- 1726-1737
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC8202968
- OpenAlex
- W2943335541
- Semantic Scholar
- 6b72ff80e4ac92f2591d9b22a357b6eaedebdcc6
- Cited by
- 1,730
- References
- 40
- Citations by year
- 2026: 120 · 2025: 191 · 2024: 253 · 2023: 243 · 2022: 247 · 2021: 318 · 2020: 263 · 2019: 85 · 2018: 2 · 2013: 1
- FWCI
- 95.51
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Celgene
- Bluebird Bio
- 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
- BCMA, chimeric antigen receptor T cells, CAR T-cell therapy, relapsed/refractory multiple myeloma, cytokine release syndrome, neurotoxicity, minimal residual disease, CAR T cell persistence, progression-free survival, hematologic toxicity, objective response rate, dose escalation, CAR-T cell expansion, complete response
- MeSH terms
- Receptors, Chimeric Antigen, Progression-Free Survival, Adult, Aged, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Multiple Myeloma, T-Lymphocytes, Immunotherapy, Adoptive, CD4-CD8 Ratio, B-Cell Maturation Antigen
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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