Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

Part of paid clinical trials in San Francisco, California.

Sponsor
Celgene
Study ID
NCT03361748
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bb2121 — BIOLOGICAL
    : bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA02 CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).

Study Details

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Key Dates

Start date
Dec 13, 2017
Status verified
May 2025
Primary completion
Dec 20, 2023
Completion
Dec 20, 2023

Study Design

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

Arms

  • Experimental: Administration of bb2121
    bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy.

Primary Outcome Measure

Overall Response Rate [ Time Frame: From first dose to 24 Months ]

Locations (18)

FacilityCityStateZIPSite coordinators
Local Institution - 108San FranciscoCalifornia94143-
University of California - San FranciscoSan FranciscoCalifornia94143-
Emory UniversityAtlantaGeorgia30322-
Local Institution - 103AtlantaGeorgia30322-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Local Institution - 106BostonMassachusetts02215-
Local Institution - 107BostonMassachusetts02114-
Massachusetts General HospitalBostonMassachusetts02214-
Local Institution - 105RochesterMinnesota55905-
Mayo ClinicRochesterMinnesota55905-
Hackensack University Medical CenterHackensackNew Jersey07601-
Local Institution - 102HackensackNew Jersey07601-
Local Institution - 109New YorkNew York10029-
Mt. Sinai Medical CenterNew YorkNew York10029-
Local Institution - 101NashvilleTennessee37203-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Local Institution - 104DallasTexas75390-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in San Francisco, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Local Institution - 108· San Francisco, CAUniversity of California - San Francisco· San Francisco, CAEmory University· Atlanta, GALocal Institution - 103· Atlanta, GADana Farber Cancer Institute· Boston, MALocal Institution - 106· Boston, MA

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