A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refract… (NCT04245839) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
United States276 participantsStarted 2020-07-14
Plain-language summary
This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
This study is divided into three periods:
* Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
* Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
* Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
✓. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
✓. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
✓. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Adequate organ function
✓. Adequate vascular access for leukapheresis procedure