Clinical trial · Interventional
Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma
Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up
NCT04155749CI-TRIAL-00103017active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed and Refractory Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anitocabtagene-autoleucel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM 1
- description
- Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma
- interventionNames
- Drug: anitocabtagene-autoleucel
Primary outcomes (2)
- measure
- Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)
- timeFrame
- 24 months
- measure
- Establish the RP2D of the investigational agent
- timeFrame
- 24 months
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease * Documented measurable disease * Adequate organ function * Life expectancy \> 12 weeks, Eastern Cooperative Group Performance Status 0-1 Exclusion Criteria: * Plasma Cell Leukemia or History of Plasma Cell Leukemia * Patients with a history of severe hypersensitivity to DMSO should be excluded * Contraindication to fludarabine or cyclophosphamide * Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities * Active central nervous system disease involvement by malignancy or active CNS pathology
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Matthew J Frigault, Binod Dhakal, Andrzej J Jakubowiak et al. · N Engl J Med · Sep 24, 2026 · PMID 42777241 pubmed
- DERIVEDBuonato JM, Edwards JP, Zaritskaya L, Witter AR, Gupta A, LaFleur DW, Tice DA, Richman LK, Hilbert DM. Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain. Mol Cancer Ther. 2022 Jul 5;21(7):1171-1183. doi: 10.1158/1535-7163.MCT-21-0552. PMID 35737298
- DERIVEDFrigault MJ, Bishop MR, Rosenblatt J, O'Donnell EK, Raje N, Cook D, Yee AJ, Logan E, Avigan DE, Jakubowiak A, Shaw K, Daley H, Nikiforow S, Griffin F, Cornwell C, Shen A, Heery C, Maus MV. Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma. Blood Adv. 2023 Mar 14;7(5):768-777. doi: 10.1182/bloodadvances.2022007210. PMID 35468618