Phase 2, Open-Label Study Evaluating the Use of an investigational CAR-T Cell therapy in Participants with Multiple Myeloma CARTITUDE-2

What's the purpose of this trial?

This trial is evaluating the safety and efficacy of an investigational CAR-T cell medication in participants with multiple myeloma.

This trial has temporarily put patient recruitment on hold.

What will happen during the trial?

This clinical trial is seeking approximately 160 participants, who will be divided into six different groups (or cohorts). Cohorts are groups of participants who meet specific criteria with Multiple Myeloma.  Your diagnosis, past treatment history, and responses to past treatments will determine which cohort you may be eligible for. All cohorts in this trial will receive the investigational medication, with some cohorts receiving other approved therapies as well.

Treatment Involved

The investigational medication is an investigational autologous chimeric antigen receptor T cell (CAR-T) therapy. This means it is made using your own T cells and is being evaluated to determine if it will then kill cancerous myeloma cells. In this study, some of your T cells will be removed from your blood by a process called apheresis. These T cells will then be modified in a laboratory. These T cells will then be given back to you by an intravenous infusion. 

The process to modify your T cells to become CAR-T cells will be explained further by a study staff member.

Before you receive the investigational medication, you will receive a conditioning regimen of chemotherapies, cyclophosphamide and fludarabine, by intravenous infusion once daily over a period of three days.

Dependent on different factors, you may be hospitalized while you receive the investigational medication and will be hospitalized for a period afterwards. 

After discharge, you will see the study doctor for follow up once a week until day 42, and then every other week for the first 100 days. After this, follow up visits continue monthly for the first year after receiving the investigational medication, and then every two months until the study ends, your myeloma gets worse, or you leave the study.

Participants in this study will be in the study for approximately 2-3 years, and then be followed yearly for 15 years after receiving the investigational medication.

You will not be paid for taking part in this study. You may receive reimbursement or stipend(s) to help with your expenses (e.g., mileage, parking, and/or meals) for attending study visits. If a caregiver is needed to accompany you to your study visits, your caregiver may receive reimbursement or stipend(s) to offset expenses (e.g. meals) for attending study visits with you. If applicable, travel assistance (e.g. car service, train, hotel arrangements) may be offered in lieu of reimbursement, to help you get to and from your study visits and to provide accommodations as necessary during your participation in the study. The study site will discuss the options that are available for you.

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


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).


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.

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