A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03548207
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-68284528 — BIOLOGICAL
    JNJ-68284528 consist of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).

Study Details

The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).

Key Dates

Start date
Jun 29, 2018
Status verified
Jul 2025
Primary completion
Aug 23, 2022
Completion
Aug 23, 2022

Study Design

Enrollment
126 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JNJ-68284528
    After lymphodepletion JNJ-68284528 will be administered as a single infusion.

Primary Outcome Measure

Phase 1b: Number of Participants With Adverse Events as Per Severity [ Time Frame: Day 1 up to 45.2 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer Center-ScottsdalePhoenixArizona85054-
City of HopeDuarteCalifornia91010-
University of California San FranciscoSan FranciscoCalifornia94143-
University of ChicagoChicagoIllinois60637-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02215-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Mayo Clinic RochesterRochesterMinnesota55902-
University of Nebraska Medical CenterOmahaNebraska68198-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Mount Sinai Medical CenterNew YorkNew York10029-
Levine Cancer InstituteCharlotteNorth Carolina28204-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Froedtert MemorialMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Cancer Center-Scottsdale· Phoenix, AZCity of Hope· Duarte, CAUniversity of California San Francisco· San Francisco, CAUniversity of Chicago· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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