A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
NCT ID: NCT07149857
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-10-03
2028-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.
Cilta-cel
Cilta-cel will be administered as intravenous infusion.
Cyclophosphamide
Cyclophosphamide will be administered as intravenous infusion.
Induction 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.
Cohort B
Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide and fludarabine daily for 3 days, followed by Ciltacel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.
Cilta-cel
Cilta-cel will be administered as intravenous infusion.
Cyclophosphamide
Cyclophosphamide will be administered as intravenous infusion.
Induction 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.
Fludarabine
Fludarabine will be administered as intravenous infusion.
Interventions
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Cilta-cel
Cilta-cel will be administered as intravenous infusion.
Cyclophosphamide
Cyclophosphamide will be administered as intravenous infusion.
Induction 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.
Fludarabine
Fludarabine will be administered as intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Locations
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University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Royal Prince Alfred Hospital
Camperdown, , Australia
Hosp. Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Countries
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Central Contacts
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Other Identifiers
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68284528MMY2012
Identifier Type: OTHER
Identifier Source: secondary_id
2025-521975-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
68284528MMY2012
Identifier Type: -
Identifier Source: org_study_id