Drugs / Zolacabtagene- Autoleucel

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07573332 Sep 2026 → Aug 2030 expected neuromyelitis optica spectrum disorder with anti-AQP4 antibodies University of Texas Southwestern Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT06220201 Mar 2024 → Jul 2027 expected multiple sclerosis, myasthenia gravis Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Recruiting No outcome recorded
Phase 1 NCT05869955 Sep 2023 → Aug 2028 expected idiopathic inflammatory myopathy, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Recruiting No outcome recorded
Phase 1 NCT04231747 May 2020 → Feb 2024 diffuse large B-cell lymphoma Juno Therapeutics, a Subsidiary of Celgene Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07388277 Mar 2026 → Dec 2028 expected anti-neutrophil cytoplasmic antibody-associated vasculitis Massachusetts General Hospital Active not recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT07603557 Aug 2026 → May 2030 expected autoimmune hemolytic anemia, autoimmune thrombocytopenia Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Not yet recruiting No outcome recorded
Phase 2 NCT07015983 Jul 2025 → May 2028 expected lupus nephritis, systemic lupus erythematosus Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT07335562 Feb 2027 → Nov 2028 expected systemic sclerosis Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-10-25 Bristol-Myers Squibb Results Bristol Myers Squibb Presents Encouraging Data from Phase 1 Breakfree-1 Study of CD19 NEX-T™ CAR T Cell Therapy in Three Chronic Autoimmune Diseases at ACR Convergence 2025 bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced updated data and first disclosure of results in chronic, refractory autoimmune diseases from the Phase 1 Breakfree-1 study (NCT05869955) of its investigational, autologous CD19-targeted NEX-T™ CAR T cell therapy BMS-986353 (CC-97540).
2024-12-09 Bristol-Myers Squibb Results Bristol Myers Squibb Highlights Progress of Cell Therapy Portfolio at ASH 2024 with Long-Term Survival Data and Results from Expanding Pipeline bms.com ↗
Bristol Myers Squibb (NYSE: BMY) announced results from 18 presentations reinforcing its leadership in cell therapy, with data demonstrating efficacy, durability and safety of currently available therapies in blood cancers and highlighting the potential of its pipeline for future indications including autoimmune diseases.

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Zolacabtagene- Autoleucel “BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells” NCT07335562 ↗
Known as BMS-986353 “Receive CC-97540 (BMS-986353) as part of the study” NCT07573332 ↗
2

NCT07603557 ↗

NCT07335562 ↗

Known as CC 97540 “Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC 97540.” NCT04231747 ↗
6

NCT05869955 ↗

NCT06220201 ↗

NCT07015983 ↗

NCT07388277 ↗

NCT07573332 ↗

NCT04231747 ↗

Known as Zola-cel “BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells” NCT07335562 ↗
Modality Cell therapy “CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells” NCT04231747 ↗
Route Intravenous “one dose of CC 97540 administered by intravenous (IV) injection” NCT04231747 ↗
Target CD19 “CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells” NCT04231747 ↗