This study wants to evaluate how well (how well it works) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.
Official registry: https://clinicaltrials.gov/study/NCT07149857 · Janssen Research & Development, LLC · enrollment listed as 60
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Cilta-cel, Cyclophosphamide, or Induction therapy. The registry lists allocation as na. This study wants to evaluate how well (how well it works) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.
They plan to enroll about 60 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel
Interventions: Cilta-cel, Cyclophosphamide, Induction therapy, Fludarabine
Primary outcome (registry wording): Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion
Study Contact
Participate-In-This-Study1@its.jnj.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 13 sites outside the US on the same record
Background: Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S.
NCT02682667 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.
NCT05137054 · Official ClinicalTrials.gov record · Regeneron Pharmaceuticals
This study wants to collect long-term follow-up data on delayed side effects after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.
NCT05201781 · Official ClinicalTrials.gov record · Janssen Research & Development, LLC
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary