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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells
Columbia University Irving Medical Center
New York, New York, United States
RECRUITINGUniversity of Pennsylvania - Abramson Caner Center
Philadelphia, Pennsylvania, United States
RECRUITINGDetermine 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
Determine the safety of Senza5 CART5 cells
Quantify quantifying the type and frequency of adverse events
Time frame: 12 months
Determine the maximum tolerated dose (MTD)
Quantify the safety and tolerability of the highest dose
Time frame: 12 months
Determine the manufacturing feasibility of Senza5 CART5
Quantify the number of product release failures and occurrence of dose failures (inability to meet targeted dose)
Time frame: 12 months
Determine efficacy of Senza5 CART5
Measure the objective response rate
Time frame: 12 months
Determine efficacy of Senza5 CART5
Measure the complete response rate
Time frame: 12 months
Determine efficacy of Senza5 CART5
Measure the best overall response
Time frame: 12 months
Determine efficacy of Senza5 CART5
Measure the duration of response
Time frame: 12 months
Determine efficacy of Senza5 CART5
Measure the overall survival
Time frame: 12 months
Determine efficacy of Senza5 CART5
Measure the progression free survival
Time frame: 12 months
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