A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

NCT06550895 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 64407564MMY20082023-507989-76-00
• Study Type: interventional
• Target: 11
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

  An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.

  Up to 3 years and 5 months

Secondary Outcomes (7)

• Percentage of Participants With Overall Response (OR)

  Up to 3 years and 5 months

• Percentage of Participants with Very Good Partial Response (VGPR) or Better

  Up to 3 years and 5 months

• Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR)

  Up to 3 years and 5 months

• Duration of Response (DOR)

  Up to 3 years and 5 months

• Time to Response (TTR)

  Upto 3 years and 5 months

Study Arms (1)

Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy

EXPERIMENTAL

Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.

Drug: Cilta-cel; Drug: Talquetamab

Interventions

Cilta-cel DRUG

Cilta-cel infusion will be administered intravenously.

Also known as: Ciltacabtagene autoleucel, JNJ-68284528

Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy

Talquetamab DRUG

Talquetamab will be administered subcutaneously.

Also known as: JNJ-64407564

Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy

Eligibility Criteria

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

You may qualify if:

• Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
• Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy
• Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening

You may not qualify if:

• Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy
• Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment
• Receive live, attenuated vaccine within 4 weeks of enrollment
• Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
• Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (9)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

Location

Austin Hospital

Heidelberg, 3084, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab

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

Study Officials

• Janssen Research & Development, LLC Clinical trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 26, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5); AU (4)