OncoMatch/Clinical Trials/NCT07093554
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma
Is NCT07093554 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Talquetamab and Ciltacabtagene Autoleucel for relapse multiple myeloma.
Treatment: Talquetamab · Ciltacabtagene Autoleucel — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).
Must have received: anti-CD38 antibody
Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).
Must have received: immunomodulatory drug
Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).
Cannot have received: adoptive T-cell therapy (CAR T-cell therapy)
Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment.
Cannot have received: bispecific antibody
Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment.
Cannot have received: talquetamab (talquetamab)
Use of talquetamab prior to enrollment.
Cannot have received: BCMA-targeted therapy
Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and/or monoclonal antibodies.
Cannot have received: GPRC5D-targeted therapy
Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and/or monoclonal antibodies.
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant at any time.
Cannot have received: autologous stem cell transplant
Exception: within 2 months of date of enrollment
Autologous stem cell transplant within 2 months of date of enrollment.
Cannot have received: high-dose cytotoxic chemotherapy (DCEP, KD-PACE, D-PACE)
Exception: within 28 days of the enrollment date
High-dose cytotoxic chemotherapy (e.g., DCEP, KD-PACE, D-PACE) within 28 days of the enrollment date.
Cannot have received: cytotoxic chemotherapy (cyclophosphamide)
Exception: within 14 days of the enrollment date
Cytotoxic chemotherapy, such as cyclophosphamide, within 14 days of the enrollment date.
Cannot have received: proteasome inhibitor
Exception: within 7 days of the enrollment date
Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.
Cannot have received: immunomodulatory drug
Exception: within 7 days of the enrollment date
Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.
Cannot have received: anti-CD38 antibody
Exception: within 7 days of the enrollment date
Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.
Cannot have received: BCL2 inhibitor (venetoclax)
Exception: within 7 days of the enrollment date
Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.
Cannot have received: corticosteroid (dexamethasone)
Exception: cumulative dexamethasone dose of ≥ 100 mg within 14 days of the enrollment date
A cumulative dexamethasone dose of ≥ 100 mg within 14 days of the enrollment date.
Cannot have received: radiation therapy
Exception: within 7 days of the enrollment date
Radiation therapy within 7 days of the enrollment date.
Lab requirements
Blood counts
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)
Kidney function
Creatinine Clearance ≥ 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Liver function
Total Bilirubin < 2 mg/dL; AST/ALT < 5 times institutional upper limit
Cardiac function
No NYHA class III or IV CHF; no MI, unstable angina, stent, or CABG in last ≤ 6 months; ejection fraction > 40%; no severe non-ischemic cardiomyopathy
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; AST/ALT < 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. Cardiac: see exclusion criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Froedtert & the Medical College of Wisconsin · Milwaukee, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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