This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.
The Pilot part of the study will evaluate the safety, tolerability, and preliminary antitumor efficacy of CD30.CAR-T. The Pivotal part of the study will evaluate antitumor efficacy and further evaluate safety and tolerability. All study eligibility requirements, assessments, procedures, and follow-up are the same for patients in both Pilot and Pivotal parts of the study. Subjects who meet eligibility criteria will have their blood drawn by leukapheresis for manufacture the CD30.CAR-T cells. Subjects are allowed bridging chemotherapy, as per Investigator choice, while waiting for production of CD30.CAR-T. Lymphodepletion (LD) with fludarabine and bendamustine will be administered for 3 consecutive days starting on Day -5 to Day -3, prior to CD30.CAR-T infusion, which will be administered on Day 0 as a single IV infusion. Depending on disease status, eligible subjects may receive up to a total of two CD30.CAR-T infusions at the same dose, each with preceding LD chemotherapy. Subjects will be closely monitored for safety and efficacy throughout the Treatment Period until the end of study (EOS) visit at Month 24. Subjects will be followed for survival, withdrawal of consent or study closure, whichever occurs first. Health Related Quality of Life assessments will also be collected throughout the study. After the EOS visit, subjects will enter the long-term follow-up phase (LTFU) which will include survival follow-up, additional safety, efficacy and biomarker assessments, as clinically indicated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Autologous CD30.CAR-T cells infused on Day 0 after the completion of lymphodepleting chemotherapy.
Lymphodepletion chemotherapy (30 mg/m2/day) for 3 consecutive days
Lymphodepletion chemotherapy (70 mg/m2/day) for 3 consecutive days
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Pilot: Safety of autologous CD30.CAR-T
Adverse events
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pivotal: Anti-tumor effect of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014)
ORR
Time frame: As early as 6 weeks after CD30.CAR-T treatment
Pilot: Antitumor efficacy of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson et al., 2014)
ORR
Time frame: As early as 6 weeks after CD30.CAR-T treatment
Pilot: Duration of Response
DOR
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pilot: Progression Free Survival
PFS
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pilot: Overall Survival
OS
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pilot: Health Related quality of life (HRQoL) questionnaire
QoL
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pivotal: Number of patients with adverse events as a measure of safety and tolerability of CD30.CART cells
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MD Anderson Cancer Center
Houston, Texas, United States
Adverse events
Time frame: As early as 6 weeks after CD30.CAR-T treatment
Pivotal: Objective response rate (ORR as assessed by IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014)
ORR
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pivotal: Progression Free Survival (PFS)
PFS
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pivotal: Duration of Response (DOR)
DOR
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pivotal: Overall Survival
OS
Time frame: Minimum 24 months post-CD30.CAR-T infusion
Pivotal: Health Related quality of life (HRQoL) questionnaire
HRQoL
Time frame: Minimum 24 months post-CD30.CAR-T infusion