A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

NCT07149857 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 68284528MMY20122025-521975-30-00
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 16

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (9)

• Overall MRD-negative CR Rate

  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

  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)

  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)

  Up to 3 years and 4 months

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

  Up to 3 years and 4 months

Study Arms (2)

Cohort A

EXPERIMENTAL

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.

Drug: Cilta-cel; Drug: Cyclophosphamide; Drug: Induction therapy

Cohort B

EXPERIMENTAL

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.

Drug: Cilta-cel; Drug: Cyclophosphamide; Drug: Induction therapy; Drug: Fludarabine

Interventions

Cilta-cel DRUG

Cilta-cel will be administered as intravenous infusion.

Also known as: JNJ-68284528

Cohort A; Cohort B

Cyclophosphamide DRUG

Cyclophosphamide will be administered as intravenous infusion.

Cohort A; Cohort B

Induction therapy DRUG

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 A; Cohort B

Fludarabine DRUG

Fludarabine will be administered as intravenous infusion.

Cohort B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (16)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

COMPLETED

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

RECRUITING

Austin Hospital

Heidelberg, 3084, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, 6150, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

RECRUITING

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Hosp. Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Clinica Univ. de Navarra

Pamplona, 31008, Spain

RECRUITING

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

RECRUITING

Hosp. Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cyclophosphamide; Neoadjuvant Therapy; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Combined Modality Therapy; Therapeutics

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): April 12, 2028
• Study Completion (Estimated): April 6, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (4); ES (8); US (4)