A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

NCT ID: NCT03744676

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2023-09-22

Brief Summary

This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.

Detailed Description

This is an open-label, multicenter, Phase 2 study to assess the safety and antitumor activity in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered with lisocabtagene maraleucel (JCAR017) in the outpatient setting.

Upon the successful product generation of lisocabtagene maraleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by lisocabtagene maraleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, health-related quality of life (HRQoL), and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, per health regulatory authority guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration.

Conditions

Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Neoplasms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lisocabtagene maraleucel

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of lisocabtagene maraleucel. During lisocabtagene maraleucel production, subjects may receive low-dose chemotherapy for disease control. Upon successful generation of lisocabtagene maraleucel product, subjects will receive treatment which will include lymphodepleting chemotherapy followed by one dose of lisocabtagene maraleucel administered by intravenous (IV) injection.

Group Type: EXPERIMENTAL

lisocabtagene maraleucel

Intervention Type: BIOLOGICAL

lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection

Interventions

lisocabtagene maraleucel

lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection

Intervention Type: BIOLOGICAL

Other Intervention Names

JCAR017; liso-cel

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years at the time of consent
• Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT.
• Positron-emission tomography-positive disease by Lugano Classification
• Eastern Cooperative Oncology Group performance status of 0 to 1
• Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function
• Adequate vascular access for leukapheresis procedure
• Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
• Subjects must agree to use appropriate contraception.

Exclusion Criteria

• Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
• History of prior allogeneic hematopoietic stem cell transplant
• Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
• History of another primary malignancy that has not been in remission for at least 2 years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on a Papanicolau smear.
• Active hepatitis B or hepatitis C infection at the time of screening
• History of or active human immunodeficiency virus infection at the time of screening
• Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel administration
• Presence of acute or chronic graft-versus-host disease
• History of clinically significant cardiac conditions within the past 6 months
• History or presence of clinically relevant CNS pathology such as epilepsy/seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
• Pregnant or nursing women
• Subject does not meet protocol-specified washout periods for certain prior treatments
• Prior CAR T-cell or other genetically modified T-cell therapy
• Progressive vascular tumor invasion, thrombosis, or embolism
• Venous thrombosis or embolism not managed on stable regimen of anticoagulation
• Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Juno Therapeutics, a Subsidiary of Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0057

Los Angeles, California, United States

Local Institution - 0060

Denver, Colorado, United States

Local Institution - 0089

Miami, Florida, United States

Local Institution - 0081

Orlando, Florida, United States

Local Institution - 0065

Indianapolis, Indiana, United States

Local Institution - 0069

Wichita, Kansas, United States

Local Institution - 0064

Louisville, Kentucky, United States

Local Institution - 0101

Southfield, Michigan, United States

Local Institution - 0052

East Brunswick, New Jersey, United States

Local Institution - 0066

Morristown, New Jersey, United States

Local Institution - 0041

Albany, New York, United States

Local Institution - 0039

Cincinnati, Ohio, United States

Local Institution - 0098

Eugene, Oregon, United States

Local Institution - 0051

Portland, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Local Institution - 0037

Greenville, South Carolina, United States

Local Institution - 0063

Nashville, Tennessee, United States

Local Institution - 0097

Dallas, Texas, United States

Local Institution - 0061

San Antonio, Texas, United States

Baylor Scott and White Health

Temple, Texas, United States

Local Institution - 0096

Tyler, Texas, United States

Local Institution - 0074

Salt Lake City, Utah, United States

Local Institution - 0036

Norfolk, Virginia, United States

Countries

United States

References

Linhares Y, Freytes CO, Cherry M, Bachier C, Maris M, Hoda D, Varela JC, Bellomo C, Cross S, Essell J, Fanning S, Terebelo H, Yimer H, Courtright J, Sharman JP, Kostic A, Vedal M, Ogasawara K, Avilion A, Espinola R, Yuan B, Mattar B. OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL. Blood Adv. 2024 Dec 10;8(23):6114-6126. doi: 10.1182/bloodadvances.2024013254.

Reference Type: DERIVED

PMID: 39347584 (View on PubMed)

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Reference Type: DERIVED

PMID: 34515338 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

Other Identifiers

017007

Identifier Type: -

Identifier Source: org_study_id