Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03277729 | A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas | PHASE1 | ACTIVE NOT_RECRUITING | 53 | — | — | Dec 5, 2017 | Mar 1, 2039 | Jan 5, 2026 | 1 | United States |
Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
| Arm | Type | Description |
|---|---|---|
| Treatment (CD20-specific CAR T cell, chemotherapy) | EXPERIMENTAL | Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. |
| Name | Type | Description |
|---|---|---|
| Chimeric Antigen Receptor T-Cell Therapy | BIOLOGICAL | Given CD20 CAR T cell IV |
| Cyclophosphamide | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Leukapheresis | PROCEDURE | Undergo leukapheresis |
| Fludarabine Phosphate | DRUG | Given IV |
Inclusion Criteria: * Patients must have B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma. Eligible lymphoma subtypes include (but not limited to): mantle cell, follicular, lymphoplasmacytic, marginal zone, transformed indolent B cell lymphoma (including transf...