A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
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- STATUS
- Recruiting
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- participants needed
- 188
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- sponsor
- Celgene
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 2 years.
Details
| Condition | Lymphoma |
|---|---|
| Age | 18-100 years |
| Treatment | Cyclophosphamide, Fludarabine, JCAR017 |
| Clinical Study Identifier | NCT04245839 |
| Sponsor | Celgene |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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