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).

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines
  • Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than (<) 12 months after treatment with autologous stem cell transplantation (ASCT) or <12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
  • Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
  • Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation

Cohort A, B, C

  • Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours
  • Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
  • Cohort A, B, C, D: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Exclusion Criteria:

- Cohort A, B, D: Any therapy that is targeted to BCMA

Cohort A, B, C, D

  • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
  • Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C) or 14 days (Cohort D) prior to apheresis
  • Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
  • Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder

Additional Trial Information

Phase 2

Enrollment: 160 patients (estimated)

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Published Results

Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma

June 02, 2021

CARTITUDE-1

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). Updated results from the Phase 1b/2 CARTITUDE-1 study (n=97) with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlighting a deepening response over time (increasing from 67 percent presented at ASH 2020).

CARTITUDE-2

Findings from Cohort A (n=20) in the Phase 2 CARTITUDE-2 (NCT04133636) study evaluating the safety and efficacy of cilta-cel in patients with multiple myeloma whose disease progressed after one to three prior lines of therapy, and who were lenalidomide refractory, will be presented for the first time at ASCO (Abstract #8013) and as an oral presentation at the European Hematology Association (EHA) Congress (Abstract #S190). Results from this cohort showed early and deep responses at a median of 5.8 months of follow-up2, and an ORR of 95 percent with 45 percent of patients achieving a sCR, 30 percent of patients achieving a CR, 10 percent of patients achieving a VGPR, and 10 percent of patients achieving a PR.2 The overall safety profile, including incidence of CRS and most common hematologic AEs, was consistent with observations in the CARTITUDE clinical development program.

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

June 01, 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.

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

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

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

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