Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

PHASE1CompletedINTERVENTIONAL
Enrollment

387

Participants

Timeline

Start Date

January 6, 2016

Primary Completion Date

May 16, 2024

Study Completion Date

May 16, 2024

Conditions
Non-Hodgkin LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaMantle-cell LymphomaPrimary Mediastinal B-cell Lymphoma
Interventions
BIOLOGICAL

JCAR017 (lisocabtagene maraleucel) single-dose schedule

Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.

BIOLOGICAL

JCAR017 (lisocabtagene maraleucel) 2-dose schedule

Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon product availability, participants will receive study treatment consisting of lymphodepleting chemotherapy followed by two IV doses of JCAR017.

Trial Locations (14)

10065

Local Institution - 0001, New York

15232

Local Institution - 0029, Pittsburgh

28204

Local Institution - 0021, Charlotte

30342

Local Institution - 0019, Atlanta

35294

Local Institution - 0006, Birmingham

60611

Local Institution - 0003, Chicago

77030

Local Institution - 0002, Houston

80045

Local Institution - 0020, Aurora

98109

Local Institution - 0018, Seattle

91010-300

Local Institution - 0007, Duarte

94143-0372

Local Institution - 0010, San Francisco

02114

Local Institution - 0005, Boston

02115

Local Institution - 0015, Boston

68198-7680

Local Institution - 0008, Omaha

All Listed Sponsors
lead

Juno Therapeutics, a Subsidiary of Celgene

INDUSTRY

NCT02631044 - Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001) | Biotech Hunter | Biotech Hunter