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NCT Number: NCT04245839

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphoma, Non-Hodgkin Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 450, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Drug

Fludarabine

Cyclophosphamide

Drug

Cyclophosphamide

JCAR017

Drug

JCAR017

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 60 months

    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"

Secondary outcomes

  1. Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"

    Time frame: Up to 60 months

    Is defined as the percentage of subjects achieving a CR at any time up to 60 months after JCAR017 treatment

  2. 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

    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

  3. Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"

    Time frame: Up to 60 months

    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

  4. Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"

    Time frame: Up to 60 months

    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

  5. Overall Survival (OS)

    Time frame: Up to 60 months

    is defined as the time from start of JCAR017 to time of death due to any cause up to 60 months after JCAR017 treatment

  6. Adverse Events (AEs)

    Time frame: Up to 60 months

    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.

  7. Pharmacokinetics - Cmax

    Time frame: Up to 60 months

    Maximum concentration

  8. Pharmacokinetics - Tmax

    Time frame: Up to 60 months

    Time to maximum concentration

  9. Pharmacokinetics - AUC

    Time frame: Up to 60 months

    Area under the curve

  10. European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)

    Time frame: Up to 24 months

    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.

  11. Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)

    Time frame: Up to 24 months

    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.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Acronym: TRANSCEND FL

Important dates

Study start
2020
Primary completion
2031
Study completion
2031
First posted
Jan 29, 2020
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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