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Clinical Trial Summary

Phase I Dose Finding: To identify the MTD of CAR19-tTregs defined as the dose level that most closely corresponds to a dose limiting toxicity rate (DLT) of <25%. Phase II Extension: To determine preliminary efficacy estimate as measured by overall response rate (ORR, complete response [CR] + partial response [PR]) at MTD of CAR19tTreg by day +28.

Clinical Trial Description

This is a single-center, single-arm, interventional phase I/II trial to evaluate the safety profile and potential efficacy of allogeneic CAR19 regulatory T cells (CAR19-tTreg) in adults with relapsed/refractory (R/R) CD19+ B Acute Lymphocytic Leukemia (B-ALL). The study consists of two components. The dose finding component is a modified version of a Phase I trial and the extended component is a modified Phase II trial. Phase I Dose Finding Component: The Phase I component incorporates the continual reassessment method (CRM) to determine the maximum tolerated dose (MTD) of CAR19-tTreg. Up to 5 doses levels will be tested. The goal of the CRM is to identify the dose level which most closely corresponds to the targeted dose limiting toxicity (DLT) rate of 25%. Patients are enrolled in cohorts beginning at the Initial Dose Level (1.0 x 10 6 CAR19-tTreg/kg). A minimum of 28 days (end of the DLT evaluation period) will separate each cohort prior to enrollment in the next cohort. In cohort 1, a minimum of 28 days separates each patient. In subsequent cohorts, a minimum of 28 days separates the 1 st and 2 nd patient and 14 days separates the 2 nd and 3 rd patient. As enrollment proceeds, each cohort is assigned to an increased, decreased or equivalent dose level based on prior data in the trial until the study sample reaches 21 or 9 patients are sequentially enrolled at the same dose. At this time, the last dose is declared the MTD and becomes the CAR19-tTreg dose for the extended component. Phase II Extended Component: The primary goal of the extended component is to study the potential efficacy of CAR19-tTreg in this patient population. Efficacy is measured using rates of complete and partial remission. A maximum of 10 patients will be enrolled at the MTD (including patients enrolled at the MTD in the phase I component). Patients will not be staggered. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05114837
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact Cancer Center Clinical Trials Office
Phone 612 624 2620
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date January 2022
Completion date March 2039

See also
  Status Clinical Trial Phase
Completed NCT03811457 - Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma N/A
Not yet recruiting NCT03975205 - To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames Early Phase 1