This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma
Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells. CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine. Subjects will be closely monitored for DLT and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Bendamustine and Fludarabine (3 days) Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0) Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0) Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)
City of Hope
Duarte, California, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas MD Anderson Cancer Centre
Houston, Texas, United States
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose
Incidence of DLTs and occurrence of study related adverse events
Time frame: Day 0 to 28 for DLT
To evaluate pharmacokinetics of autologous CD30.CAR-T
AUC (copies/ug DNA over time)
Time frame: Start of infusion of CD30.CAR-T (Day 0) until year 5
Objective Response Rate (ORR)
ORR
Time frame: Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year
Duration of Response (DOR)
DOR
Time frame: Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year
Progression Free Survival (PFS)
PFS
Time frame: Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year
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