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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03085173 | A Trial of "Armored" CAR T Cells Targeting CD19 For Patients With Relapsed CD19+ Hematologic Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 39 | — | — | Mar 15, 2017 | Mar 1, 2027 | Apr 7, 2026 | 1 | United States |
Cohorts of 3-6 patients each will be treated with escalating doses of modified T cell. At least 3 patients will be treated at each dose level with an accrual of no more than 2 patients per month within each dose level. At least two weeks will elapse from the first patient's T cell infusions before the second patient is treated (on dose level 1) to allow for toxicity and safely assessment. All patients treated at the preceding dose level will be observed a minimum of 4 weeks before dose escalation occurs.
| Arm | Type | Description |
|---|---|---|
| EGFRt/19-28z/4-1BBL CAR T cells | EXPERIMENTAL | Following enrollment, patients will undergo leukapheresis of peripheral blood for further T cell enrichment, activation and genetic modification using a retroviral vector encoding a CD19targeted CAR, the co-stimulatory ligand 4-1BBL and the EGFRt safety system (EGFRt/19-28z/4-1BBL). These T cells will be expanded and after the appropriate number of cells is generated, the modified T cells may be infused fresh or frozen for later use according to standard operation procedures. Modified T cell infusions will be administered 2-7 days following completion of the treating investigator's choice of conditioning chemotherapy. Serial sampling of blood and bone marrow will be performed following treatment to assess toxicity, therapeutic effects, and survival of the genetically modified T cells. |
| Name | Type | Description |
|---|---|---|
| EGFRt/19-28z/4-1BBL CAR T cells | BIOLOGICAL | Cohorts of 3-6 patients will be infused with escalating doses of EGFRt/19-28z/4-1BBL CAR T cells to establish the maximum tolerated dose (MTD). There are 4 planned dose levels: 1 x 10\^5, 3 x 10\^5, 1 x 10\^6, and 3 x 10\^6 CAR T cells/kg. |
Inclusion Criteria: * Patients must have CD19+ B cell malignancy with relapsed or refractory disease, defined as below: Patients with CLL: * Refractory to or relapsed after at least 2 prior chemo or chemoimmunotherapy (e.g. FCR, BR) requiring further treatment * Refactory to or relapsed after at ...