Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

February 1, 2018

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Multiple Myeloma
Interventions
BIOLOGICAL

JCARH125

Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JCARH125 administered intravenously (IV).

BIOLOGICAL

JCARH125 + anakinra

Participants will undergo leukapheresis to isolate PBMCs for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by two doses of anakinra administered subcutaneously and one dose of JCARH125 administered IV. Subjects receive anakinra for 5 consecutive days following JCARH125 infusion.

Trial Locations (20)

10016

Local Institution - 0006, Birmingham

10065

Local Institution - 0001, New York

14263

Local Institution - 0013, Buffalo

21231

Local Institution - 0009, Baltimore

30322

Local Institution - 0042, Atlanta

46202

Local Institution - 0061, Indianapolis

48201

Local Institution - 0062, Detroit

53226

Local Institution - 0055, Milwaukee

55905

Local Institution - 0054, Rochester

60451

Local Institution - 0016, New Lenox

66205

Local Institution - 0053, Westwood

80218

Local Institution - 0060, Denver

91010

Local Institution - 0007, Duarte

94158

Local Institution - 0010, San Francisco

98104

Local Institution - 0023, Seattle

98109

Local Institution - 0018, Seattle

90095-1678

Local Institution - 0059, Los Angeles

02114

Local Institution - 0005, Boston

07601

Local Institution - 0038, Hackensack

97201-3098

Local Institution - 0058, Portland

All Listed Sponsors
lead

Juno Therapeutics, a Subsidiary of Celgene

INDUSTRY

NCT03430011 - Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter