Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma (NCT07093554) is a Phase 1 interventional studying Relapse Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Medical College of Wisconsin. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Relapse Multiple Myeloma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 31 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age \> 18 years. 2. diagnosed by tissue sample (biopsy-confirmed) diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria. 3. Have measurable disease, defined as: 1. Serum M-protein level ≥ 1.0 g/dL, or 2. Urine M-protein level ≥ 200 mg/24 hours, or 3. In patients without a measurable M-protein, an involved light chain level ≥ 10 mg/dL and an abnormal free light chain ratio. 4. Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID). 5. Patient meets the requirements for the use of talquetamab, as per the most recent FDA prescription information. 6. Patient plans to receive cilta-cel and meets the criteria for commercial use as per the most recent FDA prescription information. 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening. 8. 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: kidney function (creatinine clearance) at least 30 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal 9. Female patients must meet one of the following: 1. Postmenopausal for at least one year before the screening visit, or 2. Surgically sterile, or 3. If they are of childbearing potential: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age \> 18 years. 2. Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria. 3. Have measurable disease, defined as: 1. Serum M-protein level ≥ 1.0 g/dL, or 2. Urine M-protein level ≥ 200 mg/24 hours, or 3. In patients without a measurable M-protein, an involved light chain level ≥ 10 mg/dL and an abnormal free light chain ratio. 4. Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID). 5. Patient meets the requirements for the use of talquetamab, as per the most recent FDA prescription information. 6. Patient plans to receive cilta-cel and meets the criteria for commercial use as per the most recent FDA prescription information. 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening. 8. 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 9. Female patients must meet one of the following: 1. Postmenopausal for at least one year before the screening visit, or 2. Surgically sterile, or 3. 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.) 10. Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following: 1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR 2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR 3. 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.) 11. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Prior treatment: 1. Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment. 2. Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment. 3. Use of talquetamab prior to enrollment. 4. Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and/or monoclonal antibodies. 5. Prior allogeneic stem cell transplant at any time. 6. Autologous stem cell transplant within 2 months of date of enrollment. 7. High-dose cytotoxic chemotherapy (e.g., DCEP, KD-PACE, D-PACE) within 28 days of the enrollment date. 8. Cytotoxic chemotherapy, such as cyclophosphamide, within 14 days of the enrollment date . 9. Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date. 10. A cumulative dexamethasone dose of ≥ 100 mg within 14 days of the enrollment date . 11. Radiation therapy within 7 days of the enrollment date. 2. No ongoing Grade ≥ 3 non-hematological adverse events from prior therapy. 3. Active central nervous system (CNS) involvement. 4. Have plasma cell leukemia (PCL). 5. Have unmeasurable disease (oligosecretory or non-secretory myeloma). 6. Have concomitant AL amyloidosis. 7. Patients with severe cardiac disease. 1. Active heart disease with New York Heart Association class III or IV congestive heart failure. 2. History of myocardial infarction, unstable angina, placement of drug-eluting or metallic stent, coronary artery bypass graft in the last ≤ 6 months. 3. Ejection fraction ≤ 40% on transthoracic echocardiography. 4. Severe non-ischemic cardiomyopathy. 8. Patients with pulmonary dysfunction requiring continuous supplemental oxygen ≥ 2L/minute. 9. Any serious medical condition such as: 1. Disabling neurological or psychiatric conditions, including altered mental status, dementia, or any condition that could preclude the use of high-dose steroids and/or accurate assessment of neurotoxicity. 2. Any condition that could impair the ability of the subject to receive any of the study drugs. 10. Infections: 1. No new uncontrolled clinically significant bacterial, viral or fungal infections. 2. HIV-positive patients on combination antiretroviral therapy are not eligible. 11. Pregnant women are excluded from this study because talquetamab and cilta-cel have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with talquetamab, breastfeeding should be discontinued if the mother is treated with talquetamab.

Treatments Being Tested

DRUG

Talquetamab

Talquetamab will be administered subcutaneously.

DRUG

Ciltacabtagene Autoleucel

Ciltacabtagene Autoleucel will be administered intravenously.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07093554), the sponsor (Medical College of Wisconsin), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07093554 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07093554?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07093554?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07093554. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07093554. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.