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Relapse Multiple MyelomaPhase 1NCT07093554

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

A Phase 1 study testing Talquetamab and Ciltacabtagene Autoleucel in people with Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Talquetamab and Ciltacabtagene Autoleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
2 Dec 2025to 1 Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • 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.

Who cannot join

  • 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.
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  • 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).
  • Have unmeasurable disease (oligosecretory or non-secretory myeloma).
  • Have concomitant AL amyloidosis.
  • Patients with severe cardiac disease.
  • Active heart disease with New York Heart Association class III or IV congestive heart failure.
  • History of myocardial infarction, unstable angina, placement of drug-eluting or metallic stent, coronary artery bypass graft in the last ≤ 6 months.
  • Ejection fraction ≤ 40% on transthoracic echocardiography.
  • Severe non-ischemic cardiomyopathy.
  • Patients with pulmonary dysfunction requiring continuous supplemental oxygen ≥ 2L/minute.
  • Any serious medical condition such as:
  • 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.
  • Any condition that could impair the ability of the subject to receive any of the study drugs.
  • Infections:
  • No new uncontrolled clinically significant bacterial, viral or fungal infections.
  • HIV-positive patients on combination antiretroviral therapy are not eligible.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Medical College of Wisconsin Cancer Center Clinical Trials Office contact

866-680-0505 ext. 8900

cccto@mcw.edu

United States1 site, 1 recruiting

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Othman Akhtar, MBBS, 414-805-4600, oakhtar@mcw.edu

    Othman Akhtar, MBBS

    Recruiting

Other trials in United States

About this study

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).

Read the detailed description

This study will enroll patients with RRMM who have received at least one prior line of therapy and are eligible for both commercial talquetamab and cilta-cel. Patients will enroll prior to apheresis. Following apheresis, patients will receive one cycle of talquetamab therapy. An additional cycle of talquetamab will be allowed if manufacturing delays result in an expected lymphodepletion date > 4 weeks from the last full dose of talquetamab in Cycle 1. Following successful manufacturing, patients will receive lymphodepleting chemotherapy and cilta-cel infusion.

Being tested
Talquetamab, Ciltacabtagene Autoleucel
Keywords
Bispecific Antibody, CAR-T therapy, Refractory Multiple Myeloma, Relapse Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalquetamabDrug

    Talquetamab will be administered subcutaneously.

  • Ciltacabtagene AutoleucelDrug

    Ciltacabtagene Autoleucel will be administered intravenously.

Study groups in NCT07093554
Study groupRoleWhat they receive
Talquetamab and Ciltacabtagene autoleucelExperimentalParticipants 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.
Receives: Drug: Talquetamab; Drug: Ciltacabtagene Autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day+30 post Ciltacabtagene Autoleucel infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start2 Dec 2025
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07093554
Sponsor's protocol ID
PRO00055520
Status last verified
Dec 2025
First submitted
23 Jul 2025
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Talquetamab and Ciltacabtagene Autoleucel in people with Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of subjects without serious adverse events following Ciltacabtagene Autoleucel infusion through Day +30. (time frame: Day+30 post Ciltacabtagene Autoleucel infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07093554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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