ciltacabtagene autoleucel
Cell therapy targets TNFRSF17
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Carvykti | — | 2022-05-25 | europa.eu ↗ |
Trials 18 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07093554 | Dec 2025 → Jul 2027 expected | plasma cell myeloma | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 1 | NCT06623630 | Dec 2024 → Jun 2027 expected | plasma cell myeloma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT05666700 | Dec 2023 → Jan 2026 overdue | plasma cell myeloma | Peter MacCallum Cancer Centre, Australia | Recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03548207 | Jun 2018 → Aug 2022 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT03090659 | Oct 2015 → Dec 2023 | refractory plasma cell neoplasm | Nanjing Legend Biotech Co. | Unknown | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07149857 | Oct 2025 → Apr 2028 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06574126 | Sep 2024 → Sep 2032 expected | smoldering plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT06550895 | Sep 2024 → Aug 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05767359 | Apr 2023 → Dec 2025 overdue | smoldering plasma cell myeloma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05347485 | May 2022 → Nov 2023 | plasma cell myeloma | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04133636 | Nov 2019 → Feb 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03758417 | Jan 2019 → Jul 2025 | plasma cell myeloma | Nanjing Legend Biotech Co. | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05257083 | Oct 2023 → Jun 2033 expected | plasma cell myeloma | Stichting European Myeloma Network | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04923893 | Aug 2021 → Feb 2029 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04181827 | Jun 2020 → May 2024 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05201781 | Mar 2022 → Jul 2037 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT04452994 | — | plasma cell myeloma | Janssen Research & Development, LLC | No longer available | No outcome recorded |
| — | NCT05346835 | — | plasma cell myeloma | Janssen Scientific Affairs, LLC | Available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06940297 Background | Jun 2025 → Aug 2031 expected | plasma cell myeloma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06577025 Background | Aug 2024 → Sep 2030 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ciltacabtagene autoleucel | “The autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy LCAR-B38M has been approved for the treatment of relapsed and refractory...” PMID 38659046 ↗ Apr 20249“JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule...” NCT06574126 ↗ “JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is...” NCT05257083 ↗ “Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, is effective in heavily pretreated patients with relapsed or refractory...” PMID 37272512 ↗ Jun 2023 “CARTITUDE-1 evaluated ciltacabtagene autoleucel (cilta-cel) in patients with heavily pretreated relapsed/refractory multiple myeloma (RRMM).” PMID 40459151 ↗ Jun 2025 “Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.” NCT05346835 ↗ |
| Known as | Carvykti | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802263 ↗ |
| Known as | cilta-cel | “JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule...” NCT06574126 ↗13“PURPOSE: CARTIFAN-1 aimed to evaluate the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen-targeting chimeric antigen receptor T-cell...” PMID 36269898 ↗ Oct 2022 “Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, is effective in heavily pretreated patients with relapsed or refractory...” PMID 37272512 ↗ Jun 2023 “CARTITUDE-1 evaluated ciltacabtagene autoleucel (cilta-cel) in patients with heavily pretreated relapsed/refractory multiple myeloma (RRMM).” PMID 40459151 ↗ Jun 2025 “Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.” NCT05346835 ↗ |
| Known as | Ciltacabtagene autoleucel (cilta-cel) | “Ciltacabtagene autoleucel (cilta-cel)” NCT04133636 ↗ |
| Known as | Ciltacabtagene autoleucel, JNJ-68284528 | “Ciltacabtagene autoleucel, JNJ-68284528” NCT06550895 ↗ |
| Known as | JNJ-68284528 | “JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule...” NCT06574126 ↗4“Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent” NCT05666700 ↗ |
| Known as | JNJ-68284528(LCAR-B38M CAR-T cells) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802263 ↗ |
| Known as | LCAR-B38M | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03090659 ↗ |
| Modality | Cell therapy | “LCAR-B38M is a chimeric antigen receptor T cell product with two binding domains targeting B cell maturation antigen.” PMID 35794616 ↗ Jul 2022 |
| Route | Intravenous | “LCAR-B38M, at a median dose of 0.513 × 106 cells/kg, was intravenously administered either in three split infusions or in a single infusion.” PMID 35794616 ↗ Jul 2022 |
| Target | TNFRSF17 | “Tumor necrosis factor receptor superfamily member 17 binding agent” CHEMBL4802263 ↗ |