Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Adult and Pediatric Patients With Relapsed/Refractory HL
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|ClinicalTrials.gov Identifier: NCT04268706|
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma, Adult Hodgkin Disease Recurrent Hodgkin Disease Refractory Hodgkin Disease, Pediatric||Drug: CD30.CAR-T||Phase 2|
Subjects who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells in a lab. CD30.CAR-T cells will be infused after the completion of lymphodepleting chemotherapy with fludarabine and cyclophosphamide.
Subjects will be monitored for safety and efficacy throughout the study. Subjects will be followed for survival, withdrawal of consent or study closure, whichever occurs first.
Health Related Quality of Life assessments will be collected for pediatric and adult patients during the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multi‐Center Study Evaluating the Safety and Efficacy of CD30-directed Genetically Modified Autologous T Cells (CD30.CAR-T) in Adult and Pediatric Patients With Relapsed or Refractory CD30 Positive Classical Hodgkin Lymphoma|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||August 2024|
Experimental: CD30 positive r/r classical Hodgkin Lymphoma
Patients with relapsed or refractory classical Hodgkin Lymphoma who have failed 3 prior lines of treatment, which may include a prior autologous and/or allogeneic stem cell transplant.
Patients will be treated with autologous CD30.CAR-T cells.
autologous CD30.CAR-T cells infused on Day 0 after the completion of lymphodepleting chemotherapy.
- To assess the 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) [ Time Frame: As early as 6 weeks after CD30.CAR-T treatment ]ORR
- Number of patients with adverse events as a measure of safety and tolerability of CD30.CART cells [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]Number of patients with treatment related adverse events as assessed by CTCAE v5.0
- Progression Free Survival (PFS) [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]PFS
- Duration of Response (DOR) [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]DOR
- Objective Response Rate as assessed by the Investigator [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]ORR by Investigator
- Overall survival [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]Survival
- Health Related quality of life (HRQoL) questionnaire [ Time Frame: Minimum 24 months post-CD30.CAR-T infusion ]QoL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268706
|Contact: Lotus Yungemail@example.com|
|Principal Investigator:||Helen Heslop, MD||Baylor College of Medicine|