Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

NCT03483103 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 017006
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 59

Brief Summary

This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.

Conditions

Lymphoma, Nonhodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Keywords

JCAR017; lisocabtagene maraleucel; NHL; chimeric antigen receptor; CAR; CAR T cell; autologous T cell therapy; immunotherapy; cell therapy; liso-cel

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake \> mediastinum but ≤ liver; 4- uptake moderately \> liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

  From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)

Secondary Outcomes (36)

• Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)

  From first dose to 90 days following first dose (up to approximately 90 days)

• Change From Baseline of Hematology Laboratory Results: Hemoglobin

  Baseline and Day 29

• Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets

  Baseline and Day 29

• Change From Baseline of Chemistry Laboratory Results: Albumin

  Baseline and Day 29

• Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase

  Baseline and Day 29

Study Arms (1)

Treatment

EXPERIMENTAL

Lisocabtagene maraleucel at a dose of 100×10\^6 CAR+ T cells (50×10\^6 CD8+ CAR+ T cells and 50×10\^6 CD4+ CAR+ T cells), will be given IV in a single-dose schedule on Day 1 (between 2 and 7 days following the completion of lymphodepleting chemotherapy).

Biological: lisocabtagene maraleucel

Interventions

lisocabtagene maraleucel BIOLOGICAL

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

Also known as: JCAR017, liso-cel

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma \[tFL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma \[DHL/THL\]), and follicular lymphoma Grade 3B per WHO 2016 classification
• Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
• Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
• Positron emission tomography (PET)-positive disease
• Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
• ECOG performance status of 0, or 1, or 2
• Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
• Subjects must agree to use appropriate contraception
• Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy

You may not qualify if:

• Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
• History of another primary malignancy that has not been in remission for at least 2 years.
• Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
• Active hepatitis B or hepatitis C infection at the time of screening
• History of or active human immunodeficiency virus (HIV) infection at the time of screening
• Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
• History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
• History or presence of clinically relevant CNS pathology
• Pregnant or nursing women
• Subject does not meet protocol-specified washout periods for prior treatments
• Prior hematopoietic stem cell transplant
• 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

Sponsors & Collaborators

• Juno Therapeutics, a Subsidiary of Celgene: lead

Study Sites (59)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Local Institution - 0043

Gilbert, Arizona, 85234, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

UNC School of Medicine

Los Angeles, California, 90095, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Sutter Hematology and Oncology

Sacramento, California, 95816, United States

Location

Sutter Medical Center

Sacramento, California, 95816, United States

Location

Stanford Cancer Genetics Clinic

Stanford, California, 94304, United States

Location

Local Institution - 0092

Stanford, California, 94305, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Local Institution - 0019

Atlanta, Georgia, 30342, United States

Location

The Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

Location

UNC School of Medicine

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0003

Chicago, Illinois, 60611, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Local Institution - 0016

Chicago, Illinois, 60637-1470, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Local Institution - 0046

Lexington, Kentucky, 40536, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Local Institution - 0064

Louisville, Kentucky, 40241, United States

Location

Norton Cancer Institute - Brownsboro

Louisville, Kentucky, 40241, United States

Location

UNC School of Medicine

Louisville, Kentucky, 40241, United States

Location

Johns Hopkins Oncology Center Bunting Blaustein Building

Baltimore, Maryland, 21231, United States

Location

Local Institution - 0009

Baltimore, Maryland, 21231, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Local Institution - 0052

East Brunswick, New Jersey, 08816, United States

Location

Regional Cancer Care Associates

East Brunswick, New Jersey, 08816, United States

Location

UNC School of Medicine

East Brunswick, New Jersey, 08816, United States

Location

New York Oncology Hematology - Albany Cancer Center

Albany, New York, 12208, United States

Location

New York Oncology Hematology P.C.

Albany, New York, 12208, United States

Location

Local Institution - 0090

Rochester, New York, 14642, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0021

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0039

Cincinnati, Ohio, 45236, United States

Location

Oncology Hematology Care, Inc.

Cincinnati, Ohio, 45236, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45236, United States

Location

Local Institution - 0051

Portland, Oregon, 97213, United States

Location

Providence Cancer Center/Earle A. Chiles Res. Inst.

Portland, Oregon, 97213, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Local Institution - 0029

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Greenville Health System - Cancer Institute - Faris Road

Greenville, South Carolina, 29605, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

Local Institution - 0037

Greenville, South Carolina, 29615, United States

Location

Local Institution - 0083

Dallas, Texas, 75390-7208, United States

Location

UNC School of Medicine

Dallas, Texas, 75390, United States

Location

Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant

Salt Lake City, Utah, 84143, United States

Location

Intermountain Healthcare - LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Local Institution - 0074

Salt Lake City, Utah, 84143, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

UNC School of Medicine

Tacoma, Washington, 98405, United States

Location

Local Institution - 0055

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin, Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

UNC School of Medicine

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (5)

• Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston ND, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta NK, Chow VA, Yuan B, Yang Z, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel for R/R LBCL in patients not intended for HSCT: final results of the phase 2 PILOT study. Blood Adv. 2025 Aug 12;9(15):3694-3705. doi: 10.1182/bloodadvances.2024015262.

  PMID: 40305658 DERIVED

• Ghosh N, Sehgal A, Liu FF, Kostic A, Crotta A, De Benedetti M, Faccone J, Peng L, Gordon LI. Comparative efficacy of lisocabtagene maraleucel in the PILOT study versus second-line chemotherapy regimens in the real world. Haematologica. 2025 Mar 1;110(3):693-705. doi: 10.3324/haematol.2024.285828.

  PMID: 39479862 DERIVED

• Gordon LI, Liu FF, Braverman J, Hoda D, Ghosh N, Hamadani M, Hildebrandt GC, Peng L, Guo S, Shi L, Sehgal A. Lisocabtagene maraleucel for second-line relapsed or refractory large B-cell lymphoma: patient-reported outcomes from the PILOT study. Haematologica. 2024 Mar 1;109(3):857-866. doi: 10.3324/haematol.2023.283162.

  PMID: 37646670 DERIVED

• Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston N, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta N, Dubowy R, D'Andrea A, Wang L, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1066-1077. doi: 10.1016/S1470-2045(22)00339-4. Epub 2022 Jul 12.

  PMID: 35839786 DERIVED

• 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.

  PMID: 34515338 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

855-907-3286

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: July 27, 2018
• Primary Completion: September 24, 2021
• Study Completion: December 1, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 29, 2022

Record last verified: 2023-11

Locations

US (59)