Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Noffar Bar
Study ID
NCT06993675
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Talquetamab — DRUG
    Talquetamab is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.
  • Teclistamab — DRUG
    Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.

Study Details

Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy. Participants with minimal residual disease (MRD) after front line therapy with induction and transplant have worse prognosis than those with MRD negative disease. Bispecific T-cell-based immunotherapies have the potential to promote further reduction of malignant plasma cells thus improving rates of MRD negativity and improve patient outcomes. In this study, participants who are MRD positive after front line therapy will receive consolidation with GPRC5D-targeted bispecific talquetamab. We will test MRD negative conversion and if MRD negativity was not achieved, the participant will switch to a different target using the B-cell maturation antigen TCE, teclistamab. Consolidation will be continued for up to 1 year in participants who have achieved MRD negativity. After consolidation therapy on this protocol is complete, participants may continue to be treated with standardof- care (SOC) maintenance therapy.

Key Dates

Start date
Aug 21, 2025
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: Arm 1
    Talquetamab is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration. Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.

Primary Outcome Measure

Rate of MRD Negative Response at 10^-5 Sensitivity Using NGS ClonoSEQ Assay in Participants with Newly Diagnosed Multiple Myeloma Treated with Talquetamab Consolidation With or Without Sequential Teclistamab by 12 Months [ Time Frame: 12 months from the start of treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06519
Myeloma Clinical Research Team
[email protected]
203-500-0834
Noffar Bar (PRINCIPAL_INVESTIGATOR)
Wilmot Cancer Center, Clinical Trial Office of the University of Rochester Medical CenterRochesterNew York14642
Marina Crouch
[email protected]
585-275-5863
Brea Lipe, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Yale University· New Haven, CTWilmot Cancer Center, Clinical Trial Office of the University of Rochester Medical Center· Rochester, NY

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