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RecruitingInterventionalPhase 2

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

NCT ID: NCT07149857Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

Summary

The purpose of this study is to evaluate how well (efficacy) 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.

Arms & interventions

  • DrugCilta-cel

    Cilta-cel will be administered as intravenous infusion.

  • DrugCyclophosphamide

    Cyclophosphamide will be administered as intravenous infusion.

  • DrugInduction therapy

    Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered.

  • DrugFludarabine

    Fludarabine will be administered as intravenous infusion.

Outcome measures

Primary

  • Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion

    Participants in CR or better who achieve MRD-negative status at 12 months after cilta-cel infusion with a sensitivity of 10\^-5, prior to progressive disease (PD) or subsequent anti-myeloma therapy will be reported.

    Time frame: At least 12 months after Cilta-cel infusion on Day 1

Secondary

  • Overall MRD-negative CR Rate

    Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

  • CR or better status

    Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

  • Progression Free Survival (PFS)

    Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

  • Overall Survival (OS)

    Time frame: Up to 3 years and 4 months

  • Number of Participants with Adverse Event (AE) by Severity

    Time frame: Up to 3 years and 4 months

  • Number of Participants with Abnormalities in Laboratory Parameters

    Time frame: Up to 3 years and 4 months

  • Levels of Cilta-cel T-Cell Expansion, and Persistence

    Time frame: Up to 3 years and 4 months

  • Number of Participants with Anti-Cilta-Cel Antibodies

    Time frame: Up to 3 years and 4 months

  • Percentage of Participants with Presence of Replication-competent Lentivirus (RCL)

    Time frame: Up to 3 years and 4 months

Eligibility criteria

Sex: AllAge: 18 Years to 80 YearsHealthy volunteers: No
Inclusion Criteria * Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (\>=)1.0 grams per deciliter (g/dL) or urine M-protein level \>= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain \>= 10 mg/dL and abnormal serum free light chain ratio * Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment * Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved \>= partial response (PR) on the most recent disease assessment to be enrolled * Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1 * Must be willing and able to adhere to the lifestyle restrictions specified in the protocol Exclusion Criteria * Frailty index of \>= 2 according to Myeloma Geriatric Assessment score * Known allergies, hypersensitivity, or intolerance to study intervention or its active agents * Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib * Participants who require continuous supplemental oxygen

Study locations (5)

University of California San Francisco

San Francisco, California, 94143

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Active Not Recruiting

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

Active Not Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Active Not Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel | Cancerify