A Phase 2, Open-label, Single Arm, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 (Lisocabtagene Maraleucel) in Adult Subjects With High-risk, Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)

STATUS

Recruiting
End date

Jan 17, 2025
participants needed

188
sponsor

Celgene

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Updated on 11 October 2022

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fludarabine

cyclophosphamide

hodgkin's disease

follicular lymphoma

b-cell lymphoma

marginal zone lymphoma

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, Non-Hodgkin
Treatment	cyclophosphamide, Fludarabine, JCAR017
Clinical Study Identifier	NCT04245839
Sponsor	Celgene
Last Modified on	11 October 2022

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Eligibility		Yes	No	Not Sure
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
Exclusion Criteria
	Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
	WHO subclassification of duodenal-type FL
	Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
	History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
	Prior CAR T-cell or other genetically-modified cell therapy
	History of or active human immunodeficiency virus (HIV)
	Active hepatitis B or active hepatitis C
	Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
	Active autoimmune disease requiring immunosuppressive therapy
	Presence of acute or chronic graft-versus-host=disease
	History of significant cardiovascular disease
	History or presence of clinically relevant central nervous system pathology
	Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

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A Phase 2, Open-label, Single Arm, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 (Lisocabtagene Maraleucel) in Adult Subjects With High-risk, Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)