{"id":"tbi-1301","safety":{"commonSideEffects":[{"rate":"20-40%","effect":"Fatigue"},{"rate":"10-30%","effect":"Nausea"},{"rate":"10-30%","effect":"Diarrhea"},{"rate":"10-20%","effect":"Anemia"},{"rate":"5-15%","effect":"Thrombocytopenia"}]},"_chembl":{"chemblId":"CHEMBL6014177","moleculeType":null,"molecularWeight":"427.47"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"CD47 is a protein that inhibits phagocytosis, and blocking it can stimulate the immune system to attack cancer cells. TBI-1301 works by binding to CD47 and preventing it from interacting with its receptor, SIRPα, on the surface of immune cells.","oneSentence":"TBI-1301 is a monoclonal antibody targeting CD47.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:37:33.769Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Relapsed or refractory multiple myeloma"}]},"trialDetails":[{"nctId":"NCT07174427","phase":"PHASE3","title":"Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma","status":"RECRUITING","sponsor":"Takara Bio Inc.","startDate":"2026-01-05","conditions":"Synovial Sarcomas","enrollment":5},{"nctId":"NCT05989828","phase":"PHASE1","title":"A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer","status":"SUSPENDED","sponsor":"University of Southern California","startDate":"2024-12-17","conditions":"Triple Negative Breast Cancer","enrollment":20},{"nctId":"NCT02869217","phase":"PHASE1","title":"Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2016-09","conditions":"NY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive Patients, Synovial Sarcoma, Melanoma","enrollment":22},{"nctId":"NCT03250325","phase":"PHASE1, PHASE2","title":"Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients with Synovial Sarcoma","status":"COMPLETED","sponsor":"Takara Bio Inc.","startDate":"2017-09-20","conditions":"Synovial Sarcoma","enrollment":8},{"nctId":"NCT02366546","phase":"PHASE1","title":"Investigator Initiated Phase 1 Study of TBI-1301","status":"UNKNOWN","sponsor":"Mie University","startDate":"2015-03","conditions":"Solid Tumors","enrollment":9}],"_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":["NY-ESO-1-specific TCR gene transduced T lymphocytes"],"phase":"phase_3","status":"active","brandName":"TBI-1301","genericName":"TBI-1301","companyName":"Takara Bio Inc.","companyId":"takara-bio-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"TBI-1301 is being studied in clinical trials for various cancer types, including Triple Negative Breast Cancer, Synovial Sarcomas, NY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive Patients, Synovial Sarcoma, and Melanoma. The treatment involves the use of Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}