Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

November 26, 2027

Study Completion Date

November 26, 2027

Conditions
Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Small Lymphocytic
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (85)

10021

ACTIVE_NOT_RECRUITING

Local Institution - 0035, New York

10032

WITHDRAWN

Columbia University Medical Center, New York

COMPLETED

Local Institution - 0026, New York

10065

RECRUITING

Weill Cornell Medical College, New York

15232

ACTIVE_NOT_RECRUITING

Local Institution - 0029, Pittsburgh

RECRUITING

UPMC Hillman Cancer Center, Pittsburgh

19104

RECRUITING

University of Pennsylvania - Perelman Center for Advanced Medicine, Philadelphia

RECRUITING

University of Pennsylvania Perelman Center for Advanced Medicine, Philadelphia

19107

RECRUITING

Thomas Jefferson University - Clinical Research Institute, Philadelphia

RECRUITING

Thomas Jefferson University, Philadelphia

19713

WITHDRAWN

Local Institution - 0110, Newark

20007

RECRUITING

Georgetown University Medical Center, Washington D.C.

COMPLETED

Local Institution - 0085, Washington D.C.

22903

WITHDRAWN

Local Institution - 0113, Charlottesville

23298

COMPLETED

Local Institution - 0087, Richmond

WITHDRAWN

Virginia Commonwealth University, Richmond

27705

RECRUITING

Duke University Medical Center, Durham

27710

RECRUITING

Duke University Medical Center, Durham

30322

NOT_YET_RECRUITING

Local Institution - 0104, Atlanta

30342

ACTIVE_NOT_RECRUITING

Local Institution - 0019, Atlanta

RECRUITING

The Blood and Marrow Transplant Group of Georgia (BMTGA), Atlanta

32224

RECRUITING

Mayo Clinic - Jacksonville, Jacksonville

RECRUITING

Mayo Clinic, Jacksonville

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

RECRUITING

University of Alabama Birmingham, Birmingham

40202

RECRUITING

Norton Healthcare - Norton Cancer Institute, Louisville

43210

RECRUITING

The Ohio State University Comprehensive Cancer Center, Columbus

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

46237

RECRUITING

Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT), Indianapolis

48109

RECRUITING

University Of Michigan Comprehensive Cancer Center, Ann Arbor

48201

RECRUITING

Barbara Ann Karmanos Cancer Institute, Detroit

ACTIVE_NOT_RECRUITING

Local Institution - 0062, Detroit

48202

NOT_YET_RECRUITING

Local Institution - 0109, Detroit

53226

RECRUITING

Froedtert Hospital BMT Medical College of Wisconsin, Milwaukee

RECRUITING

Medical College of Wisconsin, Milwaukee

55905

RECRUITING

Mayo Clinic, Rochester

RECRUITING

Mayo Clinic, Rochester

60611

RECRUITING

Northwestern Memorial Hospital, Chicago

RECRUITING

Northwestern University, Chicago

60637

RECRUITING

University of Chicago Medical Center, Chicago

RECRUITING

University Of Chicago Medical Center, Chicago

67124

NOT_YET_RECRUITING

Local Institution - 0107, Wichita

68198

RECRUITING

University of Nebraska Medical Center, Omaha

RECRUITING

University Of Nebraska Medical Center, Omaha

70112

COMPLETED

Local Institution - 0027, New Orleans

73104

RECRUITING

University of Oklahoma Health Sciences Center (Stephenson Cancer Center), Oklahoma City

RECRUITING

University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City

75246

RECRUITING

Baylor University Medical Center, Dallas

75390

COMPLETED

Local Institution - 0083, Dallas

RECRUITING

University of Texas Southwestern Medical Center, Dallas

75426

COMPLETED

Local Institution - 0079, Dallas

77030

RECRUITING

The University of Texas - MD Anderson Cancer Center, Houston

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

80218

RECRUITING

Colorado Blood Cancer Institute, Denver

84112

RECRUITING

Huntsman Cancer Institute, Salt Lake City

ACTIVE_NOT_RECRUITING

Local Institution - 0028, Salt Lake City

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

90095

ACTIVE_NOT_RECRUITING

Local Institution - 0059, Los Angeles

RECRUITING

University of California, Los Angeles, Los Angeles

91010

RECRUITING

City of Hope, Duarte

RECRUITING

City Of Hope, Duarte

92093

RECRUITING

UC San Diego Moores Cancer Center, La Jolla

RECRUITING

University Of California San Diego Moores Cancer Center, La Jolla

94143

ACTIVE_NOT_RECRUITING

Local Institution - 0010, San Francisco

RECRUITING

University of California, San Francisco, San Francisco

97401

COMPLETED

Local Institution - 0098, Eugene

98109

RECRUITING

Fred Hutchinson Cancer Research Center, Seattle

ACTIVE_NOT_RECRUITING

Local Institution - 0018, Seattle

02114

ACTIVE_NOT_RECRUITING

Local Institution - 0005, Boston

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

ACTIVE_NOT_RECRUITING

Local Institution - 0015, Boston

48109-5362

RECRUITING

University of Michigan Comprehensive Cancer Center, Ann Arbor

07920

NOT_YET_RECRUITING

Local Institution - 0001, Basking Ridge

08820

RECRUITING

Astera Cancer Care, Edison

07601-2191

RECRUITING

John Theurer Cancer Center, Hackensack

07601

RECRUITING

Hackensack University Medical Center, Hackensack

07960

RECRUITING

Atlantic Health System / Morristown Medical Center, Morristown

08903

COMPLETED

Local Institution - 0077, New Brunswick

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

11794-8160

RECRUITING

Stony Brook University, Stony Brook

44106-5061

RECRUITING

University Hospitals Seidman Cancer Center (Case Western), Cleveland

M5G 2C1

WITHDRAWN

Local Institution - 0112, Toronto

RECRUITING

Princess Margaret Cancer Centre, Toronto

All Listed Sponsors
lead

Juno Therapeutics, a Subsidiary of Celgene

INDUSTRY