CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) to Enhance Immunotherapy Against T Cell Non-Hodgkin Lymphoma (NHL): a First-in-human Phase I Clinical Trial
Summary
This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.
Arms & interventions
- DrugSenza5 CART5
The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells
Outcome measures
Primary
Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells
Measure the occurrence of Dose Limiting Toxicity events of each dose level per arm
Time frame: 12 months
Secondary
Determine the safety of Senza5 CART5 cells
Time frame: 12 months
Determine the maximum tolerated dose (MTD)
Time frame: 12 months
Determine the manufacturing feasibility of Senza5 CART5
Time frame: 12 months
Determine efficacy of Senza5 CART5
Time frame: 12 months
Determine efficacy of Senza5 CART5
Time frame: 12 months
Determine efficacy of Senza5 CART5
Time frame: 12 months
Determine efficacy of Senza5 CART5
Time frame: 12 months
Determine efficacy of Senza5 CART5
Time frame: 12 months
Determine efficacy of Senza5 CART5
Time frame: 12 months
Eligibility criteria
Study locations (2)
Columbia University Irving Medical Center
New York, New York, 10032
University of Pennsylvania - Abramson Caner Center
Philadelphia, Pennsylvania, 19104