{"id":"bms-986353","safety":{"commonSideEffects":[{"rate":null,"effect":"Cytokine release syndrome"},{"rate":null,"effect":"Immune effector cell-associated neurotoxicity syndrome (ICANS)"},{"rate":null,"effect":"Cytopenias"},{"rate":null,"effect":"Infections"}]},"_chembl":{"chemblId":"CHEMBL4303322","moleculeType":"Small molecule","molecularWeight":"518.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BMS-986353 is an autologous CAR-T cell therapy developed by Juno Therapeutics. It involves engineering a patient's own T cells to express a chimeric antigen receptor (CAR) that targets a defined tumor-associated antigen, enabling the modified T cells to recognize, proliferate, and destroy cancer cells. This approach harnesses the patient's immune system for targeted cancer cell elimination.","oneSentence":"BMS-986353 is a CAR-T cell therapy that redirects patient T cells to recognize and eliminate cancer cells expressing a specific tumor antigen.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:33.830Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hematologic malignancies (specific indication in Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT07015983","phase":"PHASE2","title":"A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)","status":"RECRUITING","sponsor":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","startDate":"2025-07-14","conditions":"Lupus Erythematosus, Systemic, Lupus Nephritis","enrollment":89},{"nctId":"NCT07335562","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacaptagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis","status":"NOT_YET_RECRUITING","sponsor":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","startDate":"2026-04-30","conditions":"Systemic Sclerosis","enrollment":92},{"nctId":"NCT06220201","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)","status":"RECRUITING","sponsor":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","startDate":"2024-03-28","conditions":"Multiple Sclerosis, Myasthenia Gravis","enrollment":120},{"nctId":"NCT07388277","phase":"PHASE1, PHASE2","title":"CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis","status":"NOT_YET_RECRUITING","sponsor":"Marcela V. Maus, M.D.,Ph.D.","startDate":"2026-07-09","conditions":"Antineutrophil Cytoplasmic Antibody-associated Vasculitis","enrollment":12},{"nctId":"NCT05869955","phase":"PHASE1","title":"A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)","status":"RECRUITING","sponsor":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","startDate":"2023-09-13","conditions":"Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis","enrollment":270}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CC-97540"],"phase":"phase_3","status":"active","brandName":"BMS-986353","genericName":"BMS-986353","companyName":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","companyId":"juno-therapeutics-inc-a-bristol-myers-squibb-company","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BMS-986353 is a CAR-T cell therapy that redirects patient T cells to recognize and eliminate cancer cells expressing a specific tumor antigen. Used for Hematologic malignancies (specific indication in Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}