Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies
M.D. Anderson Cancer Center
Summary
This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.
Description
Primary Objective: To establish the safety of TGFBR2 KO CAR27/IL-15 NK cells in patients with R/R lymphomas and B-ALL through the following primary endpoints * To determine the recommended phase 2 dose (RP2D) of this treatment. * To define the dose-limiting toxicity (DLT) of this treatment. Secondary Objectives: 1. To observe and record anti-tumor activity through the following secondary endpoints: * Day+ 30 complete response (CR) rate. * Day +30 overall response rate (ORR). * Day 180 progression-free survival rate 2. To quantify the persistence of infused donor TGFBR2 KO CAR27/I…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18-75 years of age. 2. Diagnosis of relapsed B-NHL, HL, T-NHL, or B-ALL in refractory relapse, defined as: * B-NHL: Failure of \>/= 1 salvage line and failure of or ineligibility for CAR-T. * HL and T-NHL: Failure of \>/= 1 salvage line or prior SCT. * ALL: Active disease (\>5% of blasts or positive MRD at a level of \>0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy. Patients with B-ALL must have either failed of or be ineligible for CAR-T cell therapy. Patients who have mutations for which there are FDA approved targeted therapi…
Interventions
- DrugFludarabine
Given by IV
- DrugTGFBR2 KO CAR27/IL-15 NK cells
Given by IV
- DrugCyclophosphamide
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas