Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
NCT ID: NCT03331198
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
320 participants
INTERVENTIONAL
2017-11-27
2027-11-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1 JCAR017 monotherapy
Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)
JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Phase 1 JCAR017 + ibrutinib
Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib
JCAR017 (lisocabtagene maraleucel) + ibrutinib
Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Phase 2 JCAR017 monotherapy
Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm
JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Phase 1 JCAR017 + venetoclax
Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.
JCAR017 (lisocabtagene maraleucel) + venetoclax
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)
Subjects will receive JCAR017 monotherapy
JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Interventions
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JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
JCAR017 (lisocabtagene maraleucel) + ibrutinib
Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
JCAR017 (lisocabtagene maraleucel) + venetoclax
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.
Eligibility Criteria
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Inclusion Criteria
1. CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or
2. SLL (lymphadenopathy and/or splenomegaly and \< 5×10\^9 CD19+ CD5+ clonal B lymphocytes/L \[\< 5000/µL\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)
* Subjects (other than those in the ibrutinib + JCAR017 combination therapy and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.
* Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:
1. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
2. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
3. DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i.
* Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:
1. be receiving ibrutinib and progressing at the time of study enrollment
2. be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a
3. have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
4. have previously received ibrutinib and have no contraindications to restarting ibrutinib
* Eastern Cooperative Oncology Group performance status of ≤ 1
* Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy
* Adequate organ function, defined as:
1. Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance \> 30 mL/min
2. Alanine aminotransferase ≤ 5 × ULN and total bilirubin \< 2.0 mg/dL (or \< 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
3. Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air
4. Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility
* Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
* If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
* Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax
* Subjects in venetoclax + JCAR017 combination cohort must:
1. have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
2. be venetoclax naive (required for dose expansion) or
3. if prior venetoclax (only for dose escalation)
4. have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation
* subjects in the venetoclax + JCAR017 combination must have hemoglobin \>=9 g/dL, absolute neutrophil count \>=500mm3 and platelets\>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
* must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry
Exclusion Criteria
* History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
* Subjects with Richter's transformation
* Prior treatment with any gene therapy product
* Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Presence of acute or extensive chronic graft versus host disease (GVHD)
* 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 (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
* History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
* Pregnant or nursing (lactating) women
* Use of any of the following medications or treatments within the noted time prior to leukapheresis:
1. Alemtuzumab within 6 months prior to leukapheresis
2. Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
3. Cladribine within 3 months prior to leukapheresis
4. Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
5. Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
6. Fludarabine within 4 weeks prior to leukapheresis
7. GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α \[TNFα\], anti-interleukin-6 \[IL-6\], or anti-interleukin-6 receptor \[IL 6R\]) within 4 weeks prior to leukapheresis
8. Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
9. Therapeutic doses of corticosteroids (defined as \> 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
11. Venetoclax within 4 days prior to leukapheresis
12. Idelalisib or duvelisib within 2 days prior to leukapheresis
13. Lenalidomide or covalent and non-covalent BTKi within 1 day prior to leukapheresis
14. Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
* Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
* Progressive vascular tumor invasion, thrombosis, or embolism
* Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
* Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
* Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
* For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued
18 Years
ALL
No
Sponsors
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Juno Therapeutics, a Subsidiary of Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama Birmingham
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
City Of Hope
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University Of California San Diego Moores Cancer Center
La Jolla, California, United States
Local Institution - 0059
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Local Institution - 0010
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Local Institution - 0110
Newark, Delaware, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Local Institution - 0085
Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Local Institution - 0104
Atlanta, Georgia, United States
Local Institution - 0019
Atlanta, Georgia, United States
The Blood and Marrow Transplant Group of Georgia (BMTGA)
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University Of Chicago Medical Center
Chicago, Illinois, United States
Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT)
Indianapolis, Indiana, United States
Local Institution - 0107
Wichita, Kansas, United States
Norton Healthcare - Norton Cancer Institute
Louisville, Kentucky, United States
Local Institution - 0027
New Orleans, Louisiana, United States
Local Institution - 0005
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Local Institution - 0015
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Local Institution - 0062
Detroit, Michigan, United States
Local Institution - 0109
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - Basking Ridge
Basking Ridge, New Jersey, United States
Astera Cancer Care
Edison, New Jersey, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, United States
Local Institution - 0077
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Local Institution - 0035
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Local Institution - 0026
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Seidman Cancer Center (Case Western)
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center (Stephenson Cancer Center)
Oklahoma City, Oklahoma, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Local Institution - 0098
Eugene, Oregon, United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Local Institution - 0029
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Local Institution - 0083
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Local Institution - 0079
Dallas, Texas, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Local Institution - 0028
Salt Lake City, Utah, United States
Local Institution - 0113
Charlottesville, Virginia, United States
Local Institution - 0087
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Local Institution - 0018
Seattle, Washington, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution - 0112
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Amitkumar Mehta, Site 0006
Role: primary
Matthew Ulrickson, Site 0043
Role: primary
Tanya Siddiqi, Site 0007
Role: primary
Thomas Kipps, Site 0025
Role: primary
Luke Mountjoy, Site 0111
Role: primary
Mohamed Kharfan-Dabaja, Site 0080
Role: primary
Site 0104
Role: primary
Shuo Ma, Site 0003
Role: primary
Peter Riedell, Site 0016
Role: primary
Anand Tandra, Site 0105
Role: primary
Site 0107
Role: primary
Don Stevens, Site 0064
Role: primary
U of M Cancer Answerline
Role: primary
Monalisa Ghosh, Site 0084
Role: primary
Site 0109
Role: primary
Clinical Trials Referral Office
Role: primary
Saad Kenderian, Site 0054
Role: primary
Julie Vose, Site 0008
Role: primary
Jae Park, Site 0001
Role: primary
Edward Licitra, Site 0114
Role: primary
Tatyana Feldman, Site 0038
Role: primary
Mohamad Cherry, Site 0106
Role: primary
Michael Schuster, Site 0089
Role: primary
Danielle Brander, Site 0030
Role: primary
Molly Gallogly, Site 0078
Role: primary
Jennifer Woyach, Site 0031
Role: primary
Adam Asch, Site 0082
Role: primary
Stephen Schuster, Site 0088
Role: primary
Usama Gergis, Site 0032
Role: primary
Linda Fukas
Role: primary
Role: backup
Houston E Holmes III, MD, FACP
Role: primary
William Wierda, Site 0002
Role: primary
Nirav Shah, Site 0055
Role: primary
Abi Vijenthira, Site 0112
Role: primary
References
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Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895.
Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, Riedell PA, Shah NN, Nath R, Fakhri B, Stephens DM, Ma S, Feldman T, Solomon SR, Schuster SJ, Perna SK, Tuazon SA, Ou SS, Papp E, Peiser L, Chen Y, Wierda WG. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023 Aug 19;402(10402):641-654. doi: 10.1016/S0140-6736(23)01052-8. Epub 2023 Jun 6.
Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21.
Related Links
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BMS Clinical Trial Patient Recruiting
BMS Clinical Trial Information
Other Identifiers
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TRANSCEND-CLL-004
Identifier Type: OTHER
Identifier Source: secondary_id
017004
Identifier Type: -
Identifier Source: org_study_id
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