Clinical Trial 23778

• Overview

  Study Title:

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

  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.

  Objective:

  Primary Cohort A: To characterize the efficacy of cilta-cel infusion following a fludarabine free LD regimen Secondary: Cohort A: To further characterize the efficacy and safety of cilta-cel infusion following a fludarabine-free LD regimen -Efficacy -Safety -Pharmacokinetics -Immunogenicity To determine whether RCL is present in participants that receive cilta-cel Exploratory: To characterize the following after cilta-cel infusion following fludarabine-free conditioning regimen -CAR-T phenotypic and functional markers -Pharmacodynamics -Further exploration of MRD negativity

• Treatments

  Therapies:

  Cell Therapy

  Medications:

  JNJ-68284528 (ciltacabtagene autoleucel); ciltacabtagene autoleucel ()

• Inclusion Criteria

  Key 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

  Key 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

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