JCAR017 for Non-Hodgkin's Lymphoma
(TRANSCEND FL Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the treatment involves chemotherapy and cell therapy, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment JCAR017 (Lisocabtagene maraleucel) for Non-Hodgkin's Lymphoma?
Research shows that Lisocabtagene maraleucel, a type of CAR T-cell therapy, has been effective in treating large B-cell lymphoma, a type of Non-Hodgkin's Lymphoma. In a study, 73% of patients responded to the treatment, with 53% achieving complete remission, and 58% of patients survived for at least a year.12345
Is lisocabtagene maraleucel (JCAR017) safe for humans?
Lisocabtagene maraleucel (JCAR017) has been shown to have a manageable safety profile in clinical trials for large B-cell lymphoma, but it can cause serious side effects like cytokine release syndrome (a severe immune reaction) and neurological issues. Patients need to be closely monitored for at least seven days after receiving the treatment.12467
How is the treatment JCAR017 unique for Non-Hodgkin's Lymphoma?
JCAR017, also known as Lisocabtagene maraleucel or Liso-cel, is a unique treatment for Non-Hodgkin's Lymphoma because it is a CAR T-cell therapy that targets CD19 and is manufactured by separately processing CD4 and CD8 T cells, which are then administered in equal doses. This approach aims to balance efficacy and safety, offering a promising option for patients with relapsed or refractory large B-cell lymphomas.12367
What is the purpose of this trial?
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.
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for adults with relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma who've had at least one prior therapy including anti-CD20 and an alkylating agent. They should have good organ function, no central nervous system-only cancer, no history of CAR T-cell therapy, and be in fairly good health (ECOG 0 or 1).Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pretreatment
Screening assessments, leukapheresis, and Pretreatment evaluation
Treatment
Administration of lymphodepleting chemotherapy followed by JCAR017 infusion
Posttreatment
Follow-up assessments for disease status and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Fludarabine
- JCAR017
JCAR017 is already approved in United States, European Union for the following indications:
- Relapsed or refractory large B-cell lymphoma
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma (FL), or disease not otherwise specified
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania