Testing a new CAR-T therapy for multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of CS1-targeting CAR-T cells in patients with relapsed or refractory multiple myeloma who have undergone multiple prior therapies. The study aims to determine how well these CAR-T cells can target and eliminate myeloma cells, potentially improving patient outcomes. Participants will receive lymphodepleting chemotherapy followed by the experimental CAR-T treatment. The trial focuses on patients with measurable disease and specific eligibility criteria to ensure a suitable candidate population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Relapsed or refractory multiple myeloma after 3 or more prior lines of therapy, including proteasome inhibitor (e.g. bortezomib or carfilzomib), anti-CD38 therapy (e.g. daratumumab), and anti-BCMA therapies (e.g. BCMA bispecific antibodies or BCMA CAR-T)
* Measurable disease, defined as meeting at least one of the following criteria:

  * Serum M-protein ≥ 0.5 g/dL
  * Urine M-protein ≥ 200 mg/24 h
  * In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels (absolute increase) must be \>10 mg/dL for consideration of defining progression before enrollment
  * A biopsy-proven plasmacytoma
  * Bone marrow plasma cells \> 30% of total bone marrow cells
* At least 18 years of age.
* ECOG performance status ≤ 1
* Adequate renal, hepatic, respiratory, and cardiovascular function, as defined below:

  * Renal function:

    * calculated creatinine clearance ≥ 50 mL/min/1.73 m2 OR
    * radioisotope glomerular filtration rate ≥ 50 mL/min/1.73 m2 OR
    * normal serum creatinine based on age/gender per institutional normal range
  * Hepatic function:

    * ALT (SGPT) ≤ 5 x ULN for age
    * Total bilirubin ≤ 2.0 x IULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)
  * Respiratory function:

    * Minimum level of pulmonary reserve defined as oxygen saturation \> 91% measured by pulse oximetry on room air
  * Cardiovascular function:

    * LVEF ≥ 45% confirmed by echocardiogram or MUGA within 28 days of screening
* The effects of CS1 CAR-T on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (at least 2 forms of contraception, including one barrier method) prior to study entry and for 12 months after CS1 CAR-T infusion. If a female subject or female partner of a male subject becomes pregnant during therapy or within 12 months following WS-CART-CS1 infusion, the investigator must be notified in order to facilitate outcome follow-up.
* Ability to understand and willingness to sign an IRB-approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Any prior systemic therapy for multiple myeloma within 14 days before planned day of leukapheresis.
* A history of other malignancy with the exception of treated non-melanomatous skin cancers and malignancies for which all treatment was completed at least 2 years before registration and the subject has no evidence of disease.
* Currently receiving any other investigational agents.
* Receipt of any cellular therapy within 8 weeks prior to the planned start of conditioning.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CS1 CAR-T or other agents used in the study.
* History of Grade 3 CRS or ICANS with other CAR-Ts (including BCMA CAR).
* Active hepatitis B, active hepatitis C, any uncontrolled infection, or HIV infection.
* Ongoing or active infection or other serious underlying medical condition that would impair the ability to receive protocol treatment.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Armin Ghobadi, M.D. — Washington University School of Medicine
• Study coordinator: Armin Ghobadi, M.D.
• Email: arminghobadi@wustl.edu
• Phone: 314-747-2743

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Talquetamab treatment for multiple myeloma after BCMA CAR T-cell therapy

  This study is testing if talquetamab can help people with multiple myeloma who haven't improved after receiving BCMA CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06066346

• BCMA-TGFβ CAR-T Cells in Relapsed or Refractory Myeloma

  A one-arm phase 1 study tests a new BCMA-TGFβ CAR-T cell therapy to see if it is safe and provides signs of benefit in adults whose multiple myeloma has come back or persisted after prior treatments.

  Recruiting Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT05976555

• CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma

  This project will see how CAR‑T therapy affects older adults (age 60+) with relapsed or refractory B‑cell lymphomas, focusing on daily function and quality of life while they receive standard care.

  Recruiting Memorial Sloan Kettering Cancer Center · New York, New York · NCT04300998

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Understanding CAR-T Toxicities After Cilta-Cel in Multiple Myeloma

  This observational study tests how patients with multiple myeloma respond to cilta-cel treatment by tracking toxicities and trying to spot biomarkers to guide care.

  Recruiting at 3 sites Icahn School of Medicine at Mount Sinai · San Francisco, California and 2 other locations · NCT07665307

• PD-1Ab21-BCMA CAR-T consolidation for multiple myeloma with renal dysfunction

  This trial will test a BCMA-targeted CAR-T cell therapy that secretes a PD-1 antibody and interleukin-21 fusion protein as consolidation treatment for people with multiple myeloma who have kidney dysfunction.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07489534

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.