Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BCMA/CD70-targetd CAR-T · 1 trial · 4 indications
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) including the type, frequency and severity of adverse events.
The proportion of subjects who achieved the minimal, moderate, and major clinical response of the Total Improvement Score (TIS) within 6 months after reinfusion.
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
The proportion of subjects who achieved Ped ACR 30/50/70/90/100 within 6 months.
The changes from baseline in the modified Rodnan skin score (mRSS) within 6 months.
The changes from baseline in modified disease activity index (MDAI) within 6 months.
The changes from baseline in EUSTAR activity index within 6 months.
The changes from baseline in Composite Response Index (CRISS) within 6 months.
The proportion of subjects who achieved minimal disease activity, inactive disease and remission within 6 months.
The proportion of subjects who achieved the STAR response rate within 6 months.
The changes from baseline in ESSDAI within 6 months.
The changes from baseline in clinESSDAI within 6 months.
The changes from baseline in ESSPRI within 6 months.
| Arm | Type | Description |
|---|---|---|
| BCMA/CD70-targeted CAR-T | EXPERIMENTAL | The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).In Part A, three dose groups (0.3×10\^5/kg, 1×10\^5/kg, 3×10\^5/kg) are set up, starting from the low dose group to explore the safe and effective dose.Upon the completion of Part A, 1 optimal dose is selected to enter into the Part B stage. The group will then be enrolled in 1\~2 cases to continue to validate the safety and efficacy.The enrollment of 4-11 patients is expected in the each indication of the trial. |
| Name | Type | Description |
|---|---|---|
| BCMA/CD70-targetd CAR-T | BIOLOGICAL | Subjects underwent lymphocytetion cheotherapy and then received a single intravenous cell infusion |
Inclusion Criteria: * Age ≥5 years old. * To meet the diagnostic criteria of refractory B-cell-related pediatric rheumatic diseases, including but not limited to juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, and primary Sjogren's syndrome. 1. Diagnose...
BCMA/CD70 CAR-T cells is an investigational cell therapy being studied for autoimmune diseases, specifically Juvenile Dermatomyositis (JDM) and Systemic Lupus Erythematosus (SLE). It is in Phase 1 clinical development for these conditions, with trials also exploring its use in polyarticular juvenile idiopathic arthritis and systemic sclerosis.
BCMA/CD70 CAR-T cells targets two proteins, BCMA and CD70, which are expressed on certain immune cells. By engineering a patient's T cells to recognize these targets, the therapy aims to eliminate disease-driving cells in autoimmune conditions like lupus and juvenile dermatomyositis.
BCMA/CD70 CAR-T cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker DTIL. The company is conducting Phase 1 clinical trials for this investigational therapy in autoimmune indications.
BCMA/CD70 CAR-T cells is in Phase 1 clinical development. It is an investigational therapy, not yet approved by regulatory authorities. Two Phase 1 trials are currently recruiting participants to evaluate its safety and preliminary efficacy in autoimmune diseases.
BCMA/CD70 CAR-T cells is being studied in two Phase 1 trials: NCT07184450 for refractory pediatric rheumatic diseases including juvenile dermatomyositis, and NCT07318259 for refractory systemic lupus erythematosus. Both trials are recruiting in China and are uncontrolled, non-randomized studies.
Yes, BCMA/CD70 CAR-T cells is also known as BCMA/CD70-targetd CAR-T. These names refer to the same investigational cell therapy being developed by Precision BioSciences for autoimmune conditions.