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Trial Title: Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

NCT ID: NCT06297226

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Conditions: Keywords:
Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
BMS-986393
CAR T Cell Therapy
RRMM

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: BMS-986393
Description: Specified dose on specified days
Arm group label: BMS-986393

Other name: CC-95266,

Other name: GPRC5D CAR T cells

Summary: The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

Criteria for eligibility:
Criteria:
Inclusion Criteria - Documented diagnosis of multiple Mmyeloma (MM) as per International Myeloma Working Group (IMWG) criteria. - Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and anti-B cell maturation antigen (BCMA) therapy], and at least 3 prior lines of therapy (LOT). - Documented disease progression during or after their last anti-myeloma regimen as per IMWG. - Participants must have measurable disease during screening. - Have measurable disease during screening. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria - Active or history of central nervous system involvement with MM. - Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. - Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis. - Other protocol-defined Inclusion/Exclusion criteria apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Local Institution - 0001

Address:
City: Birmingham
Zip: 35294-3300
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0001

Facility:
Name: Local Institution - 0025

Address:
City: Gilbert
Zip: 85234
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0025

Facility:
Name: University of Arkansas for Medical Sciences

Address:
City: Little Rock
Zip: 72205
Country: United States

Status: Recruiting

Contact:
Last name: Sharmilan Thanendrarajan, Site 0037

Phone: 501-526-6000

Facility:
Name: UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)

Address:
City: Los Angeles
Zip: 90095
Country: United States

Status: Recruiting

Contact:
Last name: Sarah Larson, Site 0028

Phone: 310-829-5471

Facility:
Name: UCSF Helen Diller Medical Center at Parnassus Heights

Address:
City: San Francisco
Zip: 94143
Country: United States

Status: Recruiting

Contact:
Last name: Anupama Kumar, Site 0018

Phone: 415-514-0768

Facility:
Name: Colorado Blood Cancer Institute

Address:
City: Denver
Zip: 80218
Country: United States

Status: Recruiting

Contact:
Last name: Tara Gregory, Site 0049

Phone: 720-754-4800

Facility:
Name: Local Institution - 0062

Address:
City: Jacksonville
Zip: 32224
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0062

Facility:
Name: Miami Cancer Institute at Baptist Health, Inc.

Address:
City: Miami
Zip: 33176
Country: United States

Status: Recruiting

Contact:
Last name: George Nahas, Site 0045

Phone: 201-310-8558

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Status: Recruiting

Contact:
Last name: Ciara Freeman, Site 0029

Phone: 813-745-2475

Facility:
Name: Winship Cancer Institute of Emory University

Address:
City: Atlanta
Zip: 30322
Country: United States

Status: Recruiting

Contact:
Last name: Nisha Joseph, Site 0009

Phone: 502-608-5503

Facility:
Name: Northside Hospital

Address:
City: Atlanta
Zip: 30342
Country: United States

Status: Recruiting

Contact:
Last name: Scott Solomon, Site 0004

Phone: 404-255-1930

Facility:
Name: Local Institution - 0005

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0005

Facility:
Name: Local Institution - 0056

Address:
City: Chicago
Zip: 60637
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0056

Facility:
Name: University of Iowa

Address:
City: Iowa City
Zip: 52242
Country: United States

Status: Recruiting

Contact:
Last name: Chris Strouse, Site 0019

Phone: 630-917-8956

Facility:
Name: The University of Kansas Cancer Center - Westwood

Address:
City: Westwood
Zip: 66205
Country: United States

Status: Recruiting

Contact:
Last name: Leyla Shune, Site 0016

Phone: 913-588-6029

Facility:
Name: Norton Women's and Children's Hospital

Address:
City: Saint Matthews
Zip: 40207
Country: United States

Status: Recruiting

Contact:
Last name: Don Stevens, Site 0026

Phone: 502-899-3366

Facility:
Name: Local Institution - 0065

Address:
City: Baltimore
Zip: 21218
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0065

Facility:
Name: Local Institution - 0039

Address:
City: Boston
Zip: 02114
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0039

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Omar Nadeem, Site 0036

Phone: 617-632-3000

Facility:
Name: Local Institution - 0033

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0033

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Michael Slade, Site 0010

Phone: 314-454-8304

Facility:
Name: Rutgers Cancer Institute of New Jersey

Address:
City: New Brunswick
Zip: 08901
Country: United States

Status: Recruiting

Contact:
Last name: Mansi Shah, Site 0034

Phone: 732-209-5479

Facility:
Name: Roswell Park Cancer Institute

Address:
City: Buffalo
Zip: 14263
Country: United States

Status: Recruiting

Contact:
Last name: Ehsan Malek, Site 0046

Phone: 716-845-8722

Facility:
Name: Icahn School of Medicine at Mount Sinai

Address:
City: New York
Zip: 10029
Country: United States

Status: Recruiting

Contact:
Last name: Adriana Rossi, Site 0002

Phone: 646-962-6500

Facility:
Name: Local Institution - 0003

Address:
City: New York
Zip: 10065
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0003

Facility:
Name: University of North Carolina Medical Center

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Status: Recruiting

Contact:
Last name: Eben Lichtman, Site 0031

Phone: 617-842-6051

Facility:
Name: Local Institution - 0067

Address:
City: Charlotte
Zip: 28204
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0067

Facility:
Name: Oncology Hematology Care

Address:
City: Cincinnati
Zip: 45242
Country: United States

Status: Recruiting

Contact:
Last name: James Essell, Site 0054

Phone: 513-686-5482

Facility:
Name: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Contact:
Last name: Srinivas Devarakonda, Site 0032

Phone: 570-423-0522

Facility:
Name: Oregon Health and Science University

Address:
City: Portland
Zip: 97239
Country: United States

Status: Recruiting

Contact:
Last name: Amrita Desai, Site 0038

Phone: 503-494-0896

Facility:
Name: Local Institution - 0066

Address:
City: Nashville
Zip: 37203
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0066

Facility:
Name: Local Institution - 0043

Address:
City: Nashville
Zip: 37232
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0043

Facility:
Name: Local Institution - 0069

Address:
City: Austin
Zip: 78704
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0069

Facility:
Name: Local Institution - 0035

Address:
City: Dallas
Zip: 75390
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0035

Facility:
Name: University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Krina Patel, Site 0027

Phone: 713-792-6662

Facility:
Name: Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Contact:
Last name: Paul Shaughnessy, Site 0055

Phone: 210-575-6904

Facility:
Name: LDS Hospital

Address:
City: Salt Lake City
Zip: 84143
Country: United States

Status: Recruiting

Contact:
Last name: Bradley Hunter, Site 0050

Phone: 801-419-6498

Facility:
Name: Local Institution - 0068

Address:
City: Norfolk
Zip: 23502
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0068

Facility:
Name: Local Institution - 0011

Address:
City: Seattle
Zip: 98109
Country: United States

Status: Not yet recruiting

Contact:
Last name: Site 0011

Facility:
Name: University Hospital and UW Health Clinics

Address:
City: Madison
Zip: 53792
Country: United States

Status: Recruiting

Contact:
Last name: Zhubin Gahvari, Site 0015

Phone: 608-262-9317

Facility:
Name: Tom Baker Cancer Center

Address:
City: Calgary
Zip: T2N 4N2
Country: Canada

Status: Recruiting

Contact:
Last name: Nizar Bahlis, Site 0020

Phone: 4032202801

Facility:
Name: McGill University Health Centre

Address:
City: Montréal
Zip: H4A 3J1
Country: Canada

Status: Recruiting

Contact:
Last name: Michael Sebag, Site 0021

Phone: 514-934-1934-31558

Facility:
Name: Local Institution - 0057

Address:
City: Nagoya
Zip: 467-8602
Country: Japan

Status: Not yet recruiting

Contact:
Last name: Site 0057

Facility:
Name: Local Institution - 0058

Address:
City: Nishinomiya
Zip: 663-8501
Country: Japan

Status: Not yet recruiting

Contact:
Last name: Site 0058

Facility:
Name: Local Institution - 0061

Address:
City: Chiba
Zip: 260-8677
Country: Japan

Status: Not yet recruiting

Contact:
Last name: Site 0061

Facility:
Name: Local Institution - 0059

Address:
City: Kyoto
Zip: 602-8566
Country: Japan

Status: Not yet recruiting

Contact:
Last name: Site 0059

Facility:
Name: Local Institution - 0060

Address:
City: Tokyo
Zip: 150-8935
Country: Japan

Status: Not yet recruiting

Contact:
Last name: Site 0060

Start date: March 21, 2024

Completion date: June 4, 2030

Lead sponsor:
Agency: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Agency class: Industry

Source: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06297226
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06297226.html

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