Treatment for high-risk multiple myeloma using Ciltacabtagene Autoleucel and Talquetamab
A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
This study is testing if two new treatments, Ciltacabtagene Autoleucel and Talquetamab, can help people with high-risk multiple myeloma who haven't responded well to previous therapies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor, Talquetamab |
| Locations | 12 sites (Iowa City, Iowa and 11 other locations) |
| Trial ID | NCT06550895 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of two investigational therapies, Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab, in patients diagnosed with high-risk multiple myeloma. Participants must have experienced disease progression after at least three prior lines of therapy. The study aims to gather data on how well these treatments work in this specific patient population, focusing on measurable disease outcomes. The trial is interventional and is currently in Phase 2.
Who should consider this trial
Good fit: Ideal candidates are adults with a documented diagnosis of multiple myeloma who have undergone multiple lines of therapy and have shown disease progression.
Not a fit: Patients who have previously received CAR-T therapy or specific BCMA-directed therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-risk multiple myeloma who have limited treatment alternatives.
How similar studies have performed: Other studies involving CAR-T therapies and monoclonal antibodies have shown promise in treating multiple myeloma, suggesting potential for success with this combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening * Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy * Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening Exclusion Criteria: * Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy * Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment * Receive live, attenuated vaccine within 4 weeks of enrollment * Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form
Where this trial is running
Iowa City, Iowa and 11 other locations
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States (Recruiting)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Suspended)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Suspended)
- Medical College Of Wisconsin — Milwaukee, Wisconsin, United States (Suspended)
- Royal Prince Alfred Hospital — Camperdown, Australia (Recruiting)
- Austin Hospital — Heidelberg, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Australia (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.