Ciltacabtagene Autoleucel, an Anti–B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up
Open accessAbstract
PURPOSE: CARTITUDE-1, a phase Ib/II study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma, yielded early, deep, and durable responses at 12 months. Here, we present updated results 2 years after last patient in (median follow-up [MFU] approximately 28 months), including analyses of high-risk patient subgroups. METHODS: Eligible patients had relapsed/refractory multiple myeloma, had received ≥ 3 prior lines of therapy or were double refractory to a proteasome inhibitor and immunomodulatory drug and had received prior proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy. Patients received a single cilta-cel infusion 5-7 days after lymphodepletion. Responses were assessed by an independent review committee. RESULTS: At a MFU of 27.7 months (N = 97), the overall response rate was 97.9% (95% CI, 92.7 to 99.7); 82.5% (95% CI, 73.4 to 89.4) of patients achieved a stringent complete response. Median duration of response was not estimable. Median progression-free survival (PFS) and overall survival (OS) were not reached; 27-month PFS and OS rates were 54.9% (95% CI, 44.0 to 64.6) and 70.4% (95% CI, 60.1 to 78.6), respectively. Overall response rates were high across all subgroups (95.1%-100%). Duration of response, PFS, and/or OS were shorter in patients with high-risk cytogenetics, International Staging System stage III, high tumor burden, or plasmacytomas. The safety profile was manageable with no new cilta-cel–related cytokine release syndrome and one new case of parkinsonism (day 914 after cilta-cel) since the last report. CONCLUSION: At approximately 28 months MFU, patients treated with cilta-cel maintained deep and durable responses, observed in both standard and high-risk subgroups. The risk/benefit profile of cilta-cel remained favorable with longer follow-up.
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In the phase 1b-2 CARTITUDE-1 trial involving patients who had received at least three lines of therapy, the median progression-free survival was 34.9 months.
“In the phase 1b-2 CARTITUDE-1 trial involving patients who had received at least three lines of therapy, the median progressionfree survival was 34.9 months. 10-12”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [11]
The Results > Efficacy section states that median progression-free survival was not reached at a median follow-up of 27.7 months, contrary to the claimed 34.9 months. The Methods > Study Design and Treatment section confirms that CARTITUDE-1 was a phase Ib/II trial, but its eligibility criteria also allowed some patients with fewer than three prior lines of therapy. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe ORR to Carvykti in CARTITUDE-1 was 97% (95% CI, 91.2-99.4), with 67% of patients achieving sCR.
“The overall response rate (ORR) was an impressive 97% (95% CI, 91.2-99.4), with 67% of patients achieving stringent complete response (sCR).”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [246]
The Results > Efficacy section supports a very high overall response rate, reporting 97.9%, but reports an sCR rate of 82.5%, not 67%. The Abstract > Results passage gives a 95% CI for ORR of 92.7–99.7, not the cited 91.2–99.4. (LLM, conf=0.90)
Experimental — accuracy not yet measuredICANS occurred in 21% of Carvykti patients, with 9% of cases being grade 3 or 4.
“ICANS occurred in 21% of patients, with 9% of cases being grade 3 or 4 [246].”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [246]
The Results section (‘Cytokine release syndrome and neurotoxicity’; page unavailable) documents a patient with grade 3 ICANS after cilta-cel infusion. Neither that passage nor the Methods grading description gives a 21% ICANS incidence or says that 9% of cases were grade 3 or 4, so the claimed percentages are not verified by our copy. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe most common hematological adverse events with Carvykti were neutropenia (95%), anemia (68%), leukopenia (61%), thrombocytopenia (60%), and lymphocytopenia (50%).
“The most common hematological adverse events associated with Carvykti treatment included neutropenia (95%), anemia (68%), leukopenia (61%), thrombocytopenia (60%), and lymphocytopenia (50%).”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [246]
The Results section (Safety—Hematologic adverse events; page unavailable) identifies hematologic events as the most common grade 3/4 treatment-emergent adverse events and reports neutropenia and thrombocytopenia. It gives 95 and 60 as numbers of patients, not percentages, and the available passage does not substantiate the claimed percentages for anemia, leukopenia, or lymphocytopenia. (LLM, conf=0.85)
Experimental — accuracy not yet measuredAt the 12-month follow-up in CARTITUDE-1, all patients who received Carvykti maintained early, sustained, and deep remissions.
“At the 12-month follow-up, all patients who received Carvykti maintained early, sustained, and deep remissions, highlighting the durable efficacy of the treatment.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [246]
The Discussion reports sustained clinical benefit and says stringent complete responses increased from 67% at 12-month follow-up to 82.5% at 28 months. This supports early, deep, durable responses, but not the claim that all patients maintained remissions at 12 months. The Results (Efficacy) also report a 97.9% overall response rate at 27.7 months, rather than a response in every patient. (LLM, conf=0.90)
Experimental — accuracy not yet measured
Among patients with ≥CR, DOR and PFS at 15 months with elranatamab were comparable to those observed with other BCMA-targeted T-cell-redirecting therapies, suggesting similar outcomes once a deep response is achieved.
“Although follow-up is still ongoing, among patients with ≥CR, DOR and PFS at 15 months with elranatamab were comparable to those observed with other BCMA-targeted T-cell-redirecting therapies, suggesting similar outcomes once a deep response is achieved5,24,25.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [25]
The Results (Efficacy; page unavailable) report durable responses to cilta-cel and a 64.2% PFS rate at 27 months among patients with stringent complete response. The Discussion links deeper responses with higher PFS, supporting the use of this study as a comparator. Our copy does not report 15-month DOR and PFS specifically among patients with ≥CR; the comparison with elranatamab is the citing authors’ inference, not a finding of this paper. (LLM, conf=0.84)
Experimental — accuracy not yet measuredLower rates of cytopenias, cytokine release syndrome, and CAR-T-related neurotoxicity were seen in CARTITUDE-4 than in CARTITUDE-1.
“Lower rates of cytopenias, cytokine release syndrome, and CAR-T-related neurotoxicity were seen in CARTITUDE-4 than in CARTITUDE-1”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [11]
The Results (page unavailable) report hematologic adverse events, CRS, and neurotoxicity in CARTITUDE-1. The Discussion (page unavailable) mentions CARTITUDE-4 only as a trial evaluating earlier use of cilta-cel; it gives no CARTITUDE-4 safety rates or comparison showing lower rates of these events. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe incidence of movement and neurocognitive adverse events was lower in CARTITUDE-4 (0.6%) than in CARTITUDE-1 (6.0%).
“The incidence of movement and neurocognitive adverse events was also lower in CARTITUDE-4 (0.6%) than in CARTITUDE-1 (6.0%)”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [11]
The Results section identifies parkinsonism as previously termed movement and neurocognitive adverse events, and the Discussion reports a 6% incidence in CARTITUDE-1. The paper does not give a CARTITUDE-4 incidence of 0.6%; it instead reports less than 0.5% across other cilta-cel studies without identifying CARTITUDE-4. (LLM, conf=0.88)
Experimental — accuracy not yet measuredCilta-cel may have a better side-effect profile when used earlier in treatment.
“which suggests that cilta-cel may have a better side-effect profile when used earlier in treatment. 10,11”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [11]
The Discussion (page not available) says earlier use of cilta-cel may improve long-term outcomes and notes that prior treatments in this heavily pretreated group are associated with an increased risk of secondary primary malignancies. It does not say that cilta-cel itself would have fewer side effects if used earlier, so the specific safety comparison remains unsupported. (LLM, conf=0.78)
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 [16]
At a median 28-month follow-up, patients treated with Carvykti continued to show deep and long-lasting responses.
“Additionally, at a median 28-month follow-up, patients treated with Carvykti continued to show deep and long-lasting responses, demonstrating the sustained effectiveness of the therapy in RRMM patients.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [246]
In the phase 1b/2 CARTITUDE-1 study, 94 out of 97 patients treated with Carvykti experienced early, deep, and long-lasting responses.
“In the phase 1b/2 CARTITUDE-1 study, 94 out of 97 patients treated with Carvykti experienced early, deep, and long-lasting responses.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [246]
The results add to the consistently strong efficacy that cilta-cel has shown throughout its clinical development, including in similar early lines of therapy in CARTITUDE-2, and confirm the efficacy observed in heavily pretreated patients in CARTITUDE-1.
“The results also add to the consistently strong efficacy that cilta-cel has shown throughout its clinical development, including in similar, early lines of therapy populations in CARTITUDE-2, 13,14 and confirm the efficacy observed in heavily pretreated patients who received cilta-cel in CARTITUDE-1. 10,11”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [11]
The median duration of progression-free survival in CARTITUDE-4 extended beyond the median duration of detectability in CAR T cells, similar to observations in CARTITUDE-1.
“The median duration of progression-free survival in CARTITUDE-4 extended beyond the median duration of detectability in CAR T cells, a result that was similar to observations in CARTITUDE-1.”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [11]
CRS occurred in 95% of Carvykti patients, with 4% of cases classified as grade 3 or 4.
“CRS occurred in 95% of patients, with 4% of cases classified as grade 3 or 4.”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [246]
The Results safety subsection says no new cytokine release syndrome (CRS) events occurred since the earlier report, but gives neither a 95% incidence nor a 4% grade 3/4 rate. Searches for those percentages and CRS severity found no passage in our copy that verifies the figures. (LLM, conf=0.72)
Experimental — accuracy not yet measured
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- Authors
- Martin, T., Usmani, S. Z., Berdeja, J. G., Agha, M., Cohen, A. D., Hari, P., Avigan, D., Deol, A., Htut, M., Lesokhin, A., Munshi, N. C., O'Donnell, E., Stewart, A. K., Schecter, J. M., Goldberg, J. D., Jackson, C. C., Yeh, T.-M., Banerjee, A., Allred, A., Zudaire, E., Deraedt, W., Olyslager, Y., Zhou, C., Pacaud, L., Madduri, D., Jakubowiak, A., Lin, Y., & Jagannath, S.
- Affiliations
- UCSF Helen Diller Family Comprehensive Cancer Center (US)
- Memorial Sloan Kettering Cancer Center (US)
- Sarah Cannon Research Institute, Nashville, TN
- UPMC Hillman Cancer Center (US)
- Abramson Cancer Center (US)
- Medical College of Wisconsin (US)
- Beth Israel Deaconess Medical Center (US)
- Wayne State University (US)
- City Of Hope National Medical Center (US)
- Harvard University (US)
- Massachusetts General Hospital, Harvard Medical School, Boston, MA
- University Health Network (CA)
- Janssen Research & Development (United States) (US)
- Janssen R&D, Spring House, PA
- Janssen (Belgium) (BE)
- Legend Biotech (United States) (US)
- University of Chicago (US)
- Mayo Clinic (US)
- Mount Sinai Medical Center, New York, NY
- Corresponding author
- Jagannath, Sundar
- ORCID
- Martin, Thomas
- Usmani, Saad Z.
- Berdeja, Jesus G.
- Agha, Mounzer
- Cohen, Adam D.
- Hari, Parameswaran
- Avigan, David
- Deol, Abhinav
- Htut, Myo
- Lesokhin, Alexander
- Munshi, Nikhil C.
- Stewart, A. Keith
- Schecter, Jordan M.
- Jackson, Carolyn C.
- Banerjee, Arnob
- Deraedt, William
- Pacaud, Lida
- Madduri, Deepu
- Jakubowiak, Andrzej
- Lin, Yi
- Jagannath, Sundar
- Venue
- Journal of Clinical Oncology
- Published
- 2023-02-20
- Volume
- 41
- Issue
- 6
- Pages
- 1265-1274
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC9937098
- OpenAlex
- W4281714381
- Cited by
- 663
- References
- 29
- Citations by year
- 2026: 123 · 2025: 166 · 2024: 212 · 2023: 137 · 2022: 23 · 2013: 1
- FWCI
- 56.29
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Journal of Clinical Oncology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- 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 › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
- Keywords
- ciltacabtagene autoleucel, CAR T-cell therapy, BCMA, relapsed/refractory multiple myeloma, progression-free survival, overall survival, high-risk cytogenetics, plasmacytoma, cytokine release syndrome, parkinsonism, durable response, high-risk patient subgroups, lymphocyte depletion, anti-CD38 therapy
- MeSH terms
- Receptors, Chimeric Antigen, Follow-Up Studies, Humans, Multiple Myeloma, Immunotherapy, Adoptive, B-Cell Maturation Antigen, Proteasome Inhibitors, Cell- and Tissue-Based Therapy
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