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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years.

• Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria.

• Have measurable disease, defined as:

∙ Serum M-protein level ≥ 1.0 g/dL, or

‣ Urine M-protein level ≥ 200 mg/24 hours, or

‣ In patients without a measurable M-protein, an involved light chain level ≥ 10 mg/dL and an abnormal free light chain ratio.

• Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).

• Patient meets the requirements for the use of talquetamab, as per the most recent FDA prescription information.

• Patient plans to receive cilta-cel and meets the criteria for commercial use as per the most recent FDA prescription information.

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.

• Have the following clinical laboratory values at screening:

• Adequate bone marrow function:

• Hemoglobin\* ≥ 8.0 g/dL; Absolute Neutrophil Count\* ≥ 1,000/mcL; Absolute Lymphocyte Count\* ≥ 200/mcL; Platelets\* ≥ 25,000/mm\^3

• \*Transfusion and growth factor support within 72 hours allowed.

• Adequate hepatic function:

• Total Bilirubin \< 2 mg/dL; Aspartate aminotransferase (Serum Glutamic Oxaloacetic Transaminase)/Alanine Aminotransferase \< 5 times institutional upper limit

• Adequate renal function:

• Creatinine Clearance ≥ 30 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal

• Female patients must meet one of the following:

∙ Postmenopausal for at least one year before the screening visit, or

‣ Surgically sterile, or

‣ If they are of childbearing potential:

• i. Agree to practice two effective methods of contraception from the time of signing of the informed consent form through three months after the last dose of the study drug, AND ii. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or iii. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable contraception methods.)

⁃ Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:

• Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR

∙ Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR

∙ Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)

⁃ Ability to understand a written informed consent document, and the willingness to sign it.

Locations
United States
Wisconsin
Froedtert & the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Medical College of Wisconsin Cancer Center Clinical Trials Office
cccto@mcw.edu
866-680-0505
Time Frame
Start Date: 2025-12-02
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 31
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov