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

NCT07093554 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRO00055520
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Relapse Multiple Myeloma; Refractory Multiple Myeloma

Keywords

Bispecific Antibody; CAR-T therapy; Refractory Multiple Myeloma; Relapse Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• The number of subjects without serious adverse events following Ciltacabtagene Autoleucel infusion through Day +30.

  SAEs will be assessed using the NCI CTCAE v5.0 during bridging therapy and for 30 days following infusion. Immune-mediated toxicities will be graded and assessed using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading systems. SAEs that meet the definition of the primary endpoint analysis will include: 1. Any Grade 5 AE. 2. Any Grade ≥ 4 non-hematological treatment-related AE. 3. Cytokine release syndrome (Grade ≥ 3), immune-cell effector associated neurotoxicity syndrome (Grade ≥ 3) or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) of any grade.

  Day+30 post Ciltacabtagene Autoleucel infusion

Study Arms (1)

Talquetamab and Ciltacabtagene autoleucel

EXPERIMENTAL

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.

Drug: Talquetamab; Drug: Ciltacabtagene Autoleucel

Interventions

Talquetamab DRUG

Talquetamab will be administered subcutaneously.

Talquetamab and Ciltacabtagene autoleucel

Ciltacabtagene Autoleucel DRUG

Ciltacabtagene Autoleucel will be administered intravenously.

Talquetamab and Ciltacabtagene autoleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• Prior treatment:
• Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment.
• Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment.
• Use of talquetamab prior to enrollment.
• Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and/or monoclonal antibodies.
• Prior allogeneic stem cell transplant at any time.
• Autologous stem cell transplant within 2 months of date of enrollment.
• High-dose cytotoxic chemotherapy (e.g., DCEP, KD-PACE, D-PACE) within 28 days of the enrollment date.
• Cytotoxic chemotherapy, such as cyclophosphamide, within 14 days of the enrollment date .
• Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.
• A cumulative dexamethasone dose of ≥ 100 mg within 14 days of the enrollment date .
• Radiation therapy within 7 days of the enrollment date.
• No ongoing Grade ≥ 3 non-hematological adverse events from prior therapy.
• Active central nervous system (CNS) involvement.
• Have plasma cell leukemia (PCL).

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Othman Akhtar, MBBS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)