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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT04245839

Recruitment Status Recruiting

First Posted January 29, 2020

Last update posted October 23, 2020

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 2 years.

  • Condition or Disease:Lymphoma, Non-Hodgkin
  • Intervention/Treatment: Drug: Fludarabine
    Drug: Cyclophosphamide
    Drug: JCAR017
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 188 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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)
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: October 2022
  • Estimated Study Completion Date: June 2024
Arms and interventions
Arm Intervention/treatment
Experimental: Administration of JCAR017
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 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.
Drug: Fludarabine
Fludarabine

Drug: Cyclophosphamide
Cyclophosphamide

Drug: JCAR017
JCAR017
Outcome Measures
  • Primary Outcome Measures: 1. Complete Response Rate (CRR) [ Time Frame: Up to 24 months ]
    is defined as the percentage of subjects achieving a complete response (CR) at any time up to 24 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification".
  • Secondary Outcome Measures: 1. Overall response rate (ORR) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
    is defined as the percentage of subjects achieving a response (CR or PR) at any time up to 24 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 24 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 24 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 24 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 24 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 24 months ]
    is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 24 months after JCAR017 treatment
  • 5. Overall Survival (OS) [ Time Frame: Up to 24 months ]
    is defined as the time from start of JCAR017 to time of death due to any cause up to 24 months after JCAR017 treatment
  • 6. Adverse Events (AEs) [ Time Frame: Up to 24 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 24 months ]
    Maximum concentration
  • 8. Pharmacokinetics - Tmax [ Time Frame: Up to 24 months ]
    Time to maximum concentration
  • 9. Pharmacokinetics - AUC [ Time Frame: Up to 24 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 or two prior lines of systemic therapy are eligible if they
present with high risk features. Patients that received three 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)

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 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 T-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

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 37 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Thalia Farazi, M.D./Ph.D Celgene Medical Director

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04245839 History of Changes
  • Other Study ID Numbers: JCAR017-FOL-001, U1111-1244-9768, 2019-004081-18
  • First Posted: January 29, 2020 Key Record Dates
  • Last Update Posted: October 23, 2020
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: B-cell Non-Hodgkin Lymphoma (NHL)
    Relapsed or Refractory
    JCAR017
  • Additional relevant MeSH terms: Lymphoma, Non-Hodgkin
    Lymphoma, B-Cell
    Lymphoma