Basic Information

Gene symbol TNFRSF17 Synonyms BCM, BCMA, CD269, TNFRSF13A Type of gene protein-coding
Description TNF receptor superfamily member 17

GTO ID GTC0419
Trial ID NCT03430011
Disease Multiple Myeloma
Altered gene BCMA
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment JCARH125|Orvacabtagene Autoleucel
Generation2nd
PhasePhase1|Phase2
Recruitment statusActive, Not Recruiting
TitleStudy Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Year2018
CountryUnited States
Company sponsorJuno Therapeutics, a Subsidiary of Celgene
Other ID(s)H125001
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted genehuman anti-BCMA scFv; 4-1BB costimulatory domain; CD3z signaling domain

Clinical Result

Cohort1: JCARH125_dose level 1_Phase 1
Administration route intravenous infusion
Dosage 50E6 cells
Pts 14
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 42.9%(CR). Number of Participants With Dose-Limiting Toxicity:0/15; Number of Participants With Treatment-Emergent Adverse Events:14/14
Adverse reactions 5/15(All-cause Mortality); 1/14(Cardiac disorders)
References DOI: 10.1182/blood-2020-136748
Cohort2: JCARH125_dose level 2_Phase 1
Administration route intravenous infusion
Dosage 150E6 cells
Pts 30
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 33.3%(CR). Number of Participants With Dose-Limiting Toxicity:1/30; Number of Participants With Treatment-Emergent Adverse Events:30/30
Adverse reactions 22/30(All-cause Mortality); 14/30(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Immune system disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified; Nervous system disorders; Respiratory, thoracic and mediastinal disorders)
References DOI: 10.1182/blood-2020-136748
Cohort3: JCARH125_dose level 3_Phase 1
Administration route intravenous infusion
Dosage 300E6 cells
Pts 26
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 46.2%(CR). Number of Participants With Dose-Limiting Toxicity:1/27; Number of Participants With Treatment-Emergent Adverse Events:26/26
Adverse reactions 14/27(All-cause Mortality); 7/26(Blood and lymphatic system disorders; Immune system disorders; Infections and infestations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Nervous system disorders; Psychiatric disorders)
References DOI: 10.1182/blood-2020-136748
Cohort4: JCARH125_dose level 4_Phase 1
Administration route intravenous infusion
Dosage 450E6 cells
Pts 20
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 45.0%(CR). Number of Participants With Dose-Limiting Toxicity:3/22; Number of Participants With Treatment-Emergent Adverse Events:21/21
Adverse reactions 9/22(All-cause Mortality); 7/21(Blood and lymphatic system disorders; Cardiac disorders; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Nervous system disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders)
References DOI: 10.1182/blood-2020-136748
Cohort5: JCARH125_dose level 5_Phase 1
Administration route intravenous infusion
Dosage 600E6 cells
Pts 20
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 65.0%(CR). Number of Participants With Dose-Limiting Toxicity:1/22; Number of Participants With Treatment-Emergent Adverse Events:20/20
Adverse reactions 7/22(All-cause Mortality); 7/20(Blood and lymphatic system disorders; Infections and infestations; Nervous system disorders)
References DOI: 10.1182/blood-2020-136748
Cohort6: JCARH125_Anakinra_Phase 1
Administration route intravenous infusion
Dosage 600E6 cells
Pts 14
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 35.7%(CR). Number of Participants With Treatment-Emergent Adverse Events:14/14
Adverse reactions 4/14(All-cause Mortality); 5/14(Immune system disorders; Infections and infestations; Musculoskeletal and connective tissue disorders; Nervous system disorders; Psychiatric disorders)
References DOI: 10.1182/blood-2020-136748
Cohort7: JCARH125_Phase 2
Administration route intravenous infusion
Dosage 600E6 cells
Pts 24
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 54.2%(CR); 91.7%(ORR)
Adverse reactions 6/25(All-cause Mortality); 11/24(General disorders; Immune system disorders; Infections and infestations; Neoplasms benign, malignant and unspecified; Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders)
References DOI: 10.1182/blood-2020-136748
Cohort8: JCARH125_anti-myeloma therapy_Phase 2
Administration route intravenous infusion
Dosage 600E6 cells
Pts 10
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 40.0%(CR); 100.0%(ORR)
Adverse reactions 2/10(All-cause Mortality); 1/10(Nervous system disorders)
References DOI: 10.1182/blood-2020-136748

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