NCT04245839 · CITED IN SOURCE DOCUMENTS

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2025-11-05

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: 1. 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 2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent 3. 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) 4. 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 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate organ function 7. Adequate vascular access for leukapheresis procedure Exclusion Criteria: 1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL 2. WHO subclassification of duodenal-type FL 3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study) 4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies 5. Prior CAR T-cell or other genetically-modified cell therapy 6. History of or active human immunodeficiency virus (HIV) 7. Active hepatitis B or active hepatitis C 8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment 9. Active autoimmune disease requiring immunosuppressive therapy 10. Presence of acute or chronic graft-versus-host=disease 11. History of significant cardiovascular disease 12. History or presence of clinically relevant central nervous system pathology 13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
* Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents. * JCAR017 will be infused on Day 1 at a target dose of 100 × 10\^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
intervention Names
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: JCAR017
label
Administration of JCAR017
type
EXPERIMENTAL

interventions

arm Group Labels
Administration of JCAR017
description
Fludarabine
name
Fludarabine
type
DRUG
arm Group Labels
Administration of JCAR017
description
Cyclophosphamide
name
Cyclophosphamide
type
DRUG
arm Group Labels
Administration of JCAR017
description
JCAR017
name
JCAR017
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 276
type: ESTIMATED

Registered outcome plans (not posted results)

primary Outcomes

description
Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"
measure
Overall Response Rate (ORR)
time Frame
Up to 60 months

secondary Outcomes

description
Is defined as the percentage of subjects achieving a CR at any time up to 60 months after JCAR017 treatment
measure
Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"
time Frame
Up to 60 months
description
is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 60 months after JCAR017 treatment
measure
Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"
time Frame
Up to 60 months
description
is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment
measure
Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"
time Frame
Up to 60 months
description
is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment
measure
Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"
time Frame
Up to 60 months
description
is defined as the time from start of JCAR017 to time of death due to any cause up to 60 months after JCAR017 treatment
measure
Overall Survival (OS)
time Frame
Up to 60 months
description
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
measure
Adverse Events (AEs)
time Frame
Up to 60 months
description
Maximum concentration
measure
Pharmacokinetics - Cmax
time Frame
Up to 60 months
description
Time to maximum concentration
measure
Pharmacokinetics - Tmax
time Frame
Up to 60 months
description
Area under the curve
measure
Pharmacokinetics - AUC
time Frame
Up to 60 months
description
is questionnaire that will be used as a measure of health-related quality of life. The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
measure
European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
time Frame
Up to 24 months
description
is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. High scores indicate lower symptom burden.
measure
Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)
time Frame
Up to 24 months

Full study description

brief 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.

Source references

references

citation
Ahmed S, Martin Garcia-Sancho A, Reguera-Ortega JL, Cartron G, Rapoport AP, Izutsu K, Ghesquieres H, Goto H, Palomba ML, Abramson JS, Borchmann P, Jaeger U, Kamdar M, Dreyling M, Subklewe M, Dahiya S, Nastoupil LJ, Bar M, Strocchia M, Raggi M, Moro Bueno L, Papuga J, Colicino S, Morschhauser F. Durable efficacy and manageable long-term safety of lisocabtagene maraleucel in 3L+ FL: 3-year update from TRANSCEND FL. Blood. 2026 Jul 1:blood.2026034327. doi: 10.1182/blood.2026034327. Online ahead of print.
pmid
42462111
type
DERIVED
citation
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pmid
41692020
type
DERIVED
citation
Morschhauser F, Dahiya S, Palomba ML, Martin Garcia-Sancho A, Reguera Ortega JL, Kuruvilla J, Jager U, Cartron G, Izutsu K, Dreyling M, Kahl B, Ghesquieres H, Ardeshna K, Goto H, Barbui AM, Abramson JS, Borchmann P, Fleury I, Mielke S, Skarbnik A, de Vos S, Kamdar M, Karmali R, Viardot A, Farazi T, Fasan O, Lymp J, Vedal M, Nishii R, Avilion A, Papuga J, Kumar J, Nastoupil LJ. Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study. Nat Med. 2024 Aug;30(8):2199-2207. doi: 10.1038/s41591-024-02986-9. Epub 2024 Jun 3.
pmid
38830991
type
DERIVED