Immune cell therapy takes on tough blood cancers

NCT ID NCT03331198

Disease control Sponsor: Juno Therapeutics, a Subsidiary of Celgene Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study tests a treatment called JCAR017, a type of CAR T-cell therapy, for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to other treatments. The therapy uses a patient's own immune cells, which are modified in a lab to better attack cancer cells. The trial will test JCAR017 alone or combined with other drugs (ibrutinib or venetoclax) in about 320 adults to see if it is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: JCAR017 (lisocabtagene maraleucel), a CAR T-cell therapy, sometimes combined with ibrutinib or venetoclax
What this could lead to: If successful, this could offer a new treatment option for people with hard-to-treat CLL or SLL, potentially leading to long-term disease control.
What could go wrong: This is an early-phase trial (Phase 1/2), so the treatment may not work for everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome or neurological problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2017

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of: 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: * Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging. * 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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, lymphocytic, chronic, B-cell Lymphoma, small lymphocytic

Contacts and locations

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Baylor University Medical Center

Dallas, Texas, 75246, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
City of Hope

Duarte, California, 91010, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States
Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States
Local Institution - 0001

Basking Ridge, New Jersey, 07920, United States
Local Institution - 0002

Houston, Texas, 77030, United States
Local Institution - 0003

Chicago, Illinois, 60611, United States
Local Institution - 0005

Boston, Massachusetts, 02114, United States
Local Institution - 0006

Birmingham, Alabama, 35294, United States
Local Institution - 0007

Duarte, California, 91010, United States
Local Institution - 0008

Omaha, Nebraska, 68198, United States
Local Institution - 0010

San Francisco, California, 94143, United States
Local Institution - 0015

Boston, Massachusetts, 02215, United States
Local Institution - 0016

Chicago, Illinois, 60637, United States
Local Institution - 0018

Seattle, Washington, 98109, United States
Local Institution - 0019

Atlanta, Georgia, 30342, United States
Local Institution - 0025

La Jolla, California, 92093, United States
Local Institution - 0026

New York, New York, 10032, United States
Local Institution - 0027

New Orleans, Louisiana, 70112, United States
Local Institution - 0028

Salt Lake City, Utah, 84112, United States
Local Institution - 0029

Pittsburgh, Pennsylvania, 15232, United States
Local Institution - 0030

Durham, North Carolina, 27705, United States
Local Institution - 0031

Columbus, Ohio, 43210, United States
Local Institution - 0032

Philadelphia, Pennsylvania, 19107, United States
Local Institution - 0035

New York, New York, 10021, United States
Local Institution - 0038

Hackensack, New Jersey, 07601-2191, United States
Local Institution - 0043

Gilbert, Arizona, 85234, United States
Local Institution - 0054

Rochester, Minnesota, 55905, United States
Local Institution - 0055

Milwaukee, Wisconsin, 53226, United States
Local Institution - 0059

Los Angeles, California, 90095, United States
Local Institution - 0062

Detroit, Michigan, 48201, United States
Local Institution - 0064

Louisville, Kentucky, 40202, United States
Local Institution - 0077

New Brunswick, New Jersey, 08903, United States
Local Institution - 0078

Cleveland, Ohio, 44106, United States
Local Institution - 0079

Dallas, Texas, 75426, United States
Local Institution - 0080

Jacksonville, Florida, 32224, United States
Local Institution - 0082

Oklahoma City, Oklahoma, 73104, United States
Local Institution - 0083

Dallas, Texas, 75390, United States
Local Institution - 0084

Ann Arbor, Michigan, 48109, United States
Local Institution - 0085

Washington D.C., District of Columbia, 20007, United States
Local Institution - 0087

Richmond, Virginia, 23298, United States
Local Institution - 0088

Philadelphia, Pennsylvania, 19104, United States
Local Institution - 0089

Stony Brook, New York, 11794-8160, United States
Local Institution - 0098

Eugene, Oregon, 97401, United States
Local Institution - 0104

Atlanta, Georgia, 30322, United States
Local Institution - 0105

Indianapolis, Indiana, 46237, United States
Local Institution - 0106

Morristown, New Jersey, 07960, United States
Local Institution - 0107

Wichita, Kansas, 67124, United States
Local Institution - 0109

Detroit, Michigan, 48202, United States
Local Institution - 0111

Denver, Colorado, 80218, United States
Local Institution - 0112

Toronto, Ontario, M5G 2C1, Canada
Local Institution - 0114

Edison, New Jersey, 08820, United States
Local Institution - 0117

Chattanooga, Tennessee, 37403, United States
Local Institution - 0118

Winston-Salem, North Carolina, 27157, United States
Local Institution - 0119

Nashville, Tennessee, 37203, United States
Local Institution - 0120

Charlotte, North Carolina, 28204, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic

Jacksonville, Florida, 32224, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Northwestern University

Chicago, Illinois, 60611, United States
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
The Blood and Marrow Transplant Group of Georgia (BMTGA)

Atlanta, Georgia, 30342, United States
The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
University Hospitals Seidman Cancer Center (Case Western)

Cleveland, Ohio, 44106-5061, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of California, Los Angeles

Los Angeles, California, 90095, United States
University of California, San Francisco

San Francisco, California, 94143, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-5362, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Oklahoma Health Sciences Center (Stephenson Cancer Center)

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
Weill Cornell Medical College

New York, New York, 10065, United States

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