Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID03331198

An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Led by Juno Therapeutics, a Subsidiary of Celgene · Updated on 2026-03-04

320

Participants Needed

86

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of JCAR017 (lisocabtagene maraleucel), a treatment for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This Phase 1/2, open-label, multicenter study includes a Phase 1 portion to find the recommended dose of JCAR017 alone, followed by a Phase 2 portion to further assess its safety and efficacy. Separate Phase 1 groups will evaluate JCAR017 combined with ibrutinib or venetoclax. The study also examines the safety, effectiveness, and how the body processes JCAR017 in all participants. Participants will receive JCAR017 through an intravenous infusion after undergoing leukapheresis, a process to collect certain blood cells needed to make the treatment. Some participants may receive bridging anticancer therapies like venetoclax or chemotherapy during the preparation phase. Those in the ibrutinib group will continue or start ibrutinib treatment around the time of JCAR017 therapy. The venetoclax group will receive this medication before and after JCAR017 infusion. The study includes monotherapy groups as well as combination therapy groups to evaluate different treatment approaches. During the study, participants will be closely monitored for adverse events and laboratory changes for up to 48 months after treatment. Researchers will assess overall response rates and other measures such as minimal residual disease levels and quality of life. Monitoring includes physical exams, blood tests, imaging, and questionnaires. This long-term follow-up helps evaluate both safety and treatment effects over time, ensuring comprehensive data collection on participants' health throughout the study.

CONDITIONS

Brief 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Diagnosis of chronic lymphocytic leukemia (CLL) with treatment indication and measurable disease, or small lymphocytic lymphoma (SLL) confirmed by biopsy
  • Subjects (except certain combination therapy groups) must have failed or be ineligible for Bruton tyrosine kinase inhibitor (BTKi) treatment
  • Subjects in monotherapy cohorts must have failed at least 2 prior therapies if high-risk, or 3 prior therapies if standard-risk
  • Subjects in the DEME cohort must have received at least 2 prior therapies including BTKi and BCL2i
  • Subjects in the ibrutinib combination cohort must be on ibrutinib with specific progression or mutation criteria
  • 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 specific lab and function tests
  • Must have or be eligible for central or peripheral vascular access for leukapheresis
  • If prior CD19-targeted therapy was given, must have confirmed CD19-positive disease
  • Subjects in ibrutinib combination cohort must have progressed on BTKi and received prior venetoclax
  • Subjects in venetoclax combination cohort must meet specific prior therapy and blood count requirements
  • Diagnosis of CLL or SLL with measurable disease and demonstration of CLL cells in blood by flow cytometry
Not Eligible

You will not qualify if you...

  • Active central nervous system involvement by cancer
  • History of other primary malignancies 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 (GVHD)
  • Recent serious cardiovascular events or severe heart disease
  • Clinically relevant central nervous system disorders such as epilepsy, stroke with symptoms, dementia, or psychosis
  • Pregnant or breastfeeding women
  • Use of certain medications or treatments within specified timeframes before leukapheresis
  • Uncontrolled medical, psychological, social, or geographic conditions preventing study compliance
  • Progressive vascular tumor invasion, thrombosis, or embolism
  • Unstable deep vein thrombosis or embolism
  • Specific drug interactions in venetoclax combination cohort

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Until JCAR017 infusion and up to 90 days or longer post-infusion depending on cohort

Participants undergo leukapheresis to collect cells for JCAR017 production. During this time, some may receive bridging anticancer therapy such as chemotherapy, ibrutinib, or venetoclax depending on their assigned cohort. Treatment includes lymphodepleting chemotherapy followed by a single intravenous dose of JCAR017. Participants in certain cohorts may continue ibrutinib or venetoclax after JCAR017 infusion for up to 90 days or longer if beneficial.

Multiple visits including leukapheresis, chemotherapy, JCAR017 infusion, and follow-up during bridging therapy

Follow-up

Duration - Up to 48 months post treatment (up to approximately 24 months for some cohorts)

After treatment, participants are monitored for safety, adverse events, laboratory abnormalities, and treatment response for up to 48 months (or approximately 24 months for certain cohorts).

Regular visits over months to years for monitoring

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

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

F

First line of the email MUST contain NCT # and Site #.

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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Published Research Related To This Trial

Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study.

Tanya Siddiqi, David G Maloney, Saad S Kenderian...

https://pubmed.ncbi.nlm.nih.gov/37295445

Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications.

Jeffrey Teoh, Lauren F Brown

https://pubmed.ncbi.nlm.nih.gov/35610089

Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL.

Tanya Siddiqi, Jacob D Soumerai, Kathleen A Dorritie...

https://pubmed.ncbi.nlm.nih.gov/34699592