Ciltacabtagene autoleucel - Janssen Biotech/Nanjing Legend Biotech
Alternative Names: BCMA CAR-T - Janssen Biotech; BCMA CAR-T cell therapy- Janssen Biotech/Nanjing Legend Biotech; CAR-T cell therapy - Nanjing; CARVYKTI; cilta-cel; JNJ 4528; JNJ-68284528; LCAR-B38M; LCAR-B38M CAR-T cell therapy; LCARB38M/JNJ-4528Latest Information Update: 10 Sep 2025
At a glance
- Originator Legend Biotech USA; Nanjing Legend Biotech
- Developer Janssen Biotech; Legend Biotech USA; Nanjing Legend Biotech
- Class Antineoplastics; CAR-T cell therapies; Gene therapies; Immunotherapies
- Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed Multiple myeloma
- Phase II Smoldering multiple myeloma
Most Recent Events
- 02 Sep 2025 Janssen Research & Development plans a phase II trial for Multiple Myeloma (Combination therapy) in Unknown location (IV, Infusion) in September 2025 (NCT07149857)
- 20 Aug 2025 Feedback incorporated
- 11 Aug 2025 The US FDA removes the Risk Evaluation and Mitigation Strategy (REMS) for ciltacabtagene autoleucel