Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07093554
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Refractory Multiple Myeloma
  • Relapse Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talquetamab — DRUG
    Talquetamab will be administered subcutaneously.
  • Ciltacabtagene Autoleucel — DRUG
    Ciltacabtagene Autoleucel will be administered intravenously.

Study Details

This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).

Key Dates

Start date
Dec 2, 2025
Status verified
Dec 2025
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Talquetamab and Ciltacabtagene autoleucel
    Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered talquetamab as a bridging therapy during CAR T-cell manufacturing and then receive Ciltacabtagene autoleucel CAR T-cell infusion after which they will be followed up to six months.

Primary Outcome Measure

The number of subjects without serious adverse events following Ciltacabtagene Autoleucel infusion through Day +30. [ Time Frame: Day+30 post Ciltacabtagene Autoleucel infusion ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Othman Akhtar, MBBS
[email protected]
414-805-4600
Othman Akhtar, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
Froedtert & the Medical College of Wisconsin· Milwaukee, WI

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