A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2) CARTITUDE-2

What's the purpose of this trial?

Multiple myeloma is characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. The main aim of the study is to determine the safety and efficacy of JNJ-68284528 in various clinical settings. JNJ-68284528 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA).

This trial is currently open and accepting patients.

What will happen during the trial?

The study comprises of a Screening Phase (less than or equal to [<=] 28 days prior to apheresis) followed by Apheresis (will occur upon enrollment); a Treatment Phase including a conditioning regimen followed by infusion of JNJ-68284528 and post-infusion assessments from Day 1 to Day 100 (patients who receive an infusion of JNJ-68284528 should continue all subsequent assessments); and a Post-treatment Phase (Day 101 and up to the end of each study cohort).

After lymphodepletion, JNJ-68284528 will be administered as single infusion to patients in cohort A (Progressive disease after 1-3 prior lines of therapy), cohort B (Early relapse after front-line), cohort C (Relapsed/refractory multiple myeloma after PI, IMiD, anti-CD38, and anti- BCMA therapy), cohort D (Less than CR after ASCT front-line therapy; some patients will be administered JNJ-68284528 followed by lenalidomide), cohort F (Newly diagnosed multiple myeloma [NDMM] with standard risk [international staging system {ISS} Stage I and II] and after initiation of therapy). Patients in cohort E (NDMM, transplant not planned, high risk disease) will first be administered with quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd), followed by lymphodepletion and JNJ-68284528, followed by consolidation regimen of daratumumab and lenalidomide (D+R).

Additional Trial Information

Phase 2

Enrollment: 160 patients (estimated)

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Published Results

Deep Responses Yielded by Cilta-Cel in Relapsed/Refractory Multiple Myeloma

June 04, 2021

Deep and early responses were yielded with a single infusion of ciltacabtagene autoleucel (cilta-cel) in patients with previously treated, relapsed/refractory multiple myeloma, according to data from the phase 2 CARTITUDE-2 (NCT04133636) study presented virtually during the 2021 ASCO Annual Meeting.

Treatment with a target dose of cilta-cel at 0.75 x 106/kg resulted in an overall response rate (ORR) of 95% (95% CI, 75-100) with a stringent complete response rate (sCR) of 75% (95% CI, 51-91), and a very good partial response rate or better of 85% (95% CI, 62-97).

After a median follow-up of 5.8 months, the median time to first response with cilta-cel was 1 month (range, 0.7–3.3) and the median time to best response was 1.9 months (0.9–5.1). As of the January 2021 data cutoff, a median duration of response had not yet been reached.

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Trial Locations

All Trial Locations

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California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Open and Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Illinois

Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Temporarily Suspended

Indiana

Indiana University Health

Indianapolis, IN

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Montefiore Medical Center

Bronx, NY

Open and Accepting

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Pennsylvania

Abramson Cancer Center University of Pennsylvania

Philadelphia, PA

Open and Accepting

Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Not Yet Accepting

Washington

Fred Hutchinson / University of Washington Cancer Consortium Seattle Cancer Care Alliance (SCCA)

Seattle, WA

Not Yet Accepting
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