Actively Recruiting
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Led by Juno Therapeutics, a Subsidiary of Celgene · Updated on 2026-03-04
320
Participants Needed
86
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.
CONDITIONS
Official Title
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CLL needing treatment with measurable disease or diagnosis of SLL confirmed by biopsy with measurable disease
- Failure of or ineligibility for Bruton tyrosine kinase inhibitor (BTKi) treatment (except ibrutinib + JCAR017 cohort)
- For monotherapy cohorts except DEME: at least 2 prior therapies failed for high-risk or at least 3 for standard-risk CLL or SLL
- DEME cohort: at least 2 prior therapies including BTKi and BCL2i
- Ibrutinib + JCAR017 cohort: must be progressing on ibrutinib, or have received it for 6 months with less than complete response and high-risk features, or have specific mutations, or have no contraindications to restarting ibrutinib
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow function for lymphodepleting chemotherapy
- Adequate organ function including kidney, liver, lung, and heart as defined by study criteria
- Central or peripheral vascular access for leukapheresis available or planned
- If prior CD19-targeted therapy given, must have CD19-positive disease confirmed after that therapy
- Ibrutinib + JCAR017 cohort must have progressed on BTKi and received prior venetoclax
- Venetoclax + JCAR017 cohort must have failed at least 1 prior therapy including BTKi or be BTKi ineligible, be venetoclax naive for dose expansion or have met specific conditions if previously treated with venetoclax
- Venetoclax + JCAR017 cohort must have adequate blood counts unless low counts are due to bone marrow infiltration
- Diagnosis of CLL or SLL with indication for treatment and measurable disease including lymph nodes ≥1.5 cm or organ enlargement and confirmed CLL cells in blood by flow cytometry
You will not qualify if you...
- Active central nervous system involvement by cancer, unless effectively treated at least 3 months prior with no symptoms
- Other primary cancers not in remission for at least 2 years, with some exceptions
- Richter's transformation
- Prior gene therapy treatment
- Active hepatitis B, hepatitis C, or HIV infection
- Uncontrolled infections
- Acute or extensive chronic graft versus host disease
- Significant heart conditions within past 6 months including severe heart failure or recent cardiac events
- Serious brain or nervous system disorders
- Pregnant or breastfeeding women
- Recent use of specific medications or treatments prior to leukapheresis as detailed in the protocol
- Uncontrolled medical, psychological, social, or geographical issues preventing study compliance
- Progressive vascular tumors or unstable blood clots
- Use of certain medications near leukapheresis
- For venetoclax + JCAR017 cohort, use of strong CYP3A inducers or inhibitors that cannot be stopped
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
3
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
4
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
5
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
6
City Of Hope
Duarte, California, United States, 91010
Actively Recruiting
7
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
8
University Of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
9
Local Institution - 0059
Los Angeles, California, United States, 90095
Active, Not Recruiting
10
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
11
Local Institution - 0010
San Francisco, California, United States, 94143
Active, Not Recruiting
12
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
13
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
14
Local Institution - 0110
Newark, Delaware, United States, 19713
Withdrawn
15
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
16
Local Institution - 0085
Washington D.C., District of Columbia, United States, 20007
Completed
17
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
18
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
19
Local Institution - 0104
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
20
Local Institution - 0019
Atlanta, Georgia, United States, 30342
Active, Not Recruiting
21
The Blood and Marrow Transplant Group of Georgia (BMTGA)
Atlanta, Georgia, United States, 30342
Actively Recruiting
22
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
23
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
24
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
25
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
26
Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT)
Indianapolis, Indiana, United States, 46237
Actively Recruiting
27
Local Institution - 0107
Wichita, Kansas, United States, 67124
Not Yet Recruiting
28
Norton Healthcare - Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
29
Local Institution - 0027
New Orleans, Louisiana, United States, 70112
Completed
30
Local Institution - 0005
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
31
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
32
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
33
Local Institution - 0015
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
34
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-5362
Actively Recruiting
35
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
36
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
37
Local Institution - 0062
Detroit, Michigan, United States, 48201
Active, Not Recruiting
38
Local Institution - 0109
Detroit, Michigan, United States, 48202
Not Yet Recruiting
39
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
40
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
41
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
42
University Of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
43
Memorial Sloan-Kettering Cancer Center (MSKCC) - Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
44
Astera Cancer Care
Edison, New Jersey, United States, 08820
Actively Recruiting
45
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601-2191
Actively Recruiting
46
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
47
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
48
Local Institution - 0077
New Brunswick, New Jersey, United States, 08903
Completed
49
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
50
Local Institution - 0035
New York, New York, United States, 10021
Active, Not Recruiting
51
Columbia University Medical Center
New York, New York, United States, 10032
Withdrawn
52
Local Institution - 0026
New York, New York, United States, 10032
Completed
53
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
54
Stony Brook University
Stony Brook, New York, United States, 11794-8160
Actively Recruiting
55
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
56
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
57
University Hospitals Seidman Cancer Center (Case Western)
Cleveland, Ohio, United States, 44106-5061
Actively Recruiting
58
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
59
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
60
University of Oklahoma Health Sciences Center (Stephenson Cancer Center)
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
61
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
62
Local Institution - 0098
Eugene, Oregon, United States, 97401
Completed
63
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
64
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
65
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
66
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
67
Local Institution - 0029
Pittsburgh, Pennsylvania, United States, 15232
Active, Not Recruiting
68
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
69
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
70
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
71
Local Institution - 0083
Dallas, Texas, United States, 75390
Completed
72
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
73
Local Institution - 0079
Dallas, Texas, United States, 75426
Completed
74
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
75
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
76
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
77
Local Institution - 0028
Salt Lake City, Utah, United States, 84112
Active, Not Recruiting
78
Local Institution - 0113
Charlottesville, Virginia, United States, 22903
Withdrawn
79
Local Institution - 0087
Richmond, Virginia, United States, 23298
Completed
80
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Withdrawn
81
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
82
Seattle Cancer Center Alliance
Seattle, Washington, United States, 98109
Actively Recruiting
83
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
84
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
85
Local Institution - 0112
Toronto, Ontario, Canada, M5G 2C1
Withdrawn
86
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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