Actively Recruiting
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma
Led by Medical College of Wisconsin · Updated on 2026-01-05
31
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Confirmed diagnosis of multiple myeloma with evidence of progressive disease
- Measurable disease with specific serum or urine M-protein or light chain levels
- At least one prior line of therapy including proteasome inhibitor, anti-CD38 antibody, and immunomodulatory drug
- Eligibility for talquetamab as per FDA prescription information
- Eligibility for commercial use of cilta-cel as per FDA prescription information
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow, hepatic, and renal function with specified lab values
- Female participants must be postmenopausal, surgically sterile, or use effective contraception as specified
- Male participants must use effective contraception or follow abstinence guidelines
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior adoptive T-cell therapy including CAR T-cell therapy
- Prior use of bispecific antibodies or talquetamab
- Prior therapies targeting BCMA or GPRC5D
- History of allogeneic stem cell transplant
- Recent autologous stem cell transplant within 2 months
- Recent high-dose cytotoxic chemotherapy within 28 days
- Recent cytotoxic chemotherapy within 14 days
- Recent treatment with proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, or venetoclax within 7 days
- Cumulative dexamethasone dose ≥ 100 mg within 14 days
- Radiation therapy within 7 days
- Ongoing grade 3 or higher non-hematological adverse events
- Active central nervous system involvement
- Plasma cell leukemia
- Unmeasurable disease
- Concomitant AL amyloidosis
- Severe cardiac disease including specific conditions
- Pulmonary dysfunction requiring continuous oxygen ≥ 2L/min
- Serious medical conditions impairing treatment or assessment
- Uncontrolled infections
- HIV-positive on antiretroviral therapy
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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