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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using talquetamab as a bridging therapy before administering ciltacabtagene autoleucel (cilta-cel) in patients with relapsed and refractory multiple myeloma (RRMM). This phase 1b, single-arm, open-label study includes patients who have had at least one prior treatment and are eligible for both talquetamab and cilta-cel. The study aims to explore how well these therapies can be combined and managed in this patient population. Participants will first undergo a procedure called apheresis to collect cells. After this, they will receive one cycle of talquetamab given under the skin. If there are delays in manufacturing, an additional cycle of talquetamab may be provided. Once the cilta-cel product is ready, patients will receive lymphodepleting chemotherapy followed by an infusion of cilta-cel administered intravenously. The study treatment period includes these steps and is followed by monitoring. During the study, participants will be followed for up to six months after the cilta-cel infusion. Researchers will closely monitor for any serious side effects within 30 days after the cilta-cel treatment. Evaluations will include clinical assessments and laboratory tests to track safety and treatment effects. The total duration of participation depends on the treatment and follow-up schedule established by the study team.
CONDITIONS
Brief 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 greater than 18 years
- Confirmed diagnosis of multiple myeloma with progressive disease
- Measurable disease by serum or urine M-protein levels or involved light chain level
- At least one prior line of therapy including proteasome inhibitor, anti-CD38 antibody, and immunomodulatory drug
- Eligible for talquetamab use as per FDA prescription information
- Plan to receive cilta-cel and meet FDA criteria for commercial use
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow, liver, and kidney function as specified
- Female participants must be postmenopausal, surgically sterile, or agree to use effective contraception
- Male participants must agree to use barrier contraception or abstinence
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior adoptive T-cell therapy or CAR T-cell therapy
- Prior use of bispecific antibodies or talquetamab
- Previous therapy targeting BCMA or GPRC5D
- Prior allogeneic stem cell transplant
- Recent autologous stem cell transplant or high-dose chemotherapy
- Recent treatment with proteasome inhibitors, immunomodulatory drugs, anti-CD38 antibodies, venetoclax, or radiation therapy
- Ongoing Grade 3 or higher non-hematological adverse events
- Active central nervous system involvement or plasma cell leukemia
- Unmeasurable disease or concomitant AL amyloidosis
- Severe cardiac disease including heart failure class III/IV, recent heart attack or surgery, low ejection fraction, or severe cardiomyopathy
- Pulmonary dysfunction requiring supplemental oxygen of 2 liters per minute or more
- Serious neurological or psychiatric conditions affecting treatment or assessment
- Uncontrolled infections or HIV-positive patients on antiretroviral therapy
- Pregnant or breastfeeding women due to potential risks from study treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 cycles of talquetamab bridging therapy plus time for lymphodepleting chemotherapy and cilta-cel infusion
Participants receive talquetamab as a bridging therapy during CAR T-cell manufacturing, followed by lymphodepleting chemotherapy and cilta-cel infusion.
Duration - Up to 6 months
Participants are monitored for safety and adverse events after cilta-cel infusion for up to six months.
Regular visits during follow-up period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here