IL-15–armored CAR-T for relapsed or refractory multiple myeloma and plasma cell leukemia

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 open-label, single-arm Phase 2 trial uses autologous T cells engineered to express a chimeric antigen receptor plus IL-15 to enhance in vivo expansion and persistence. Participants undergo leukapheresis for CAR-T manufacturing, lymphodepleting conditioning, and a single CAR-T infusion; bridging therapy and localized radiotherapy are allowed per investigator discretion. Primary endpoints focus on efficacy and safety, while extensive exploratory correlative studies will use single-cell and bulk RNA sequencing, spatial transcriptomics, and serial ctDNA to characterize tumor microenvironment dynamics and predictors of response and toxicity. Subjects will be followed post-infusion for clinical outcomes and adverse events according to the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.
2. Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status following induction and consolidation therapy are also eligible for enrollment.
3. Age 18 to 80 years, inclusive.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
5. Estimated life expectancy \> 3 months from the date of signing the informed consent form.
6. Hemoglobin ≥ 60 g/L (transfusion permitted).
7. Adequate organ function as defined below:

   * Creatinine clearance (CrCl) ≥ 40 mL/min, calculated using the Cockcroft-Gault formula;
   * Left ventricular ejection fraction (LVEF) ≥ 50%;
   * Oxygen saturation \> 90% on room air;
   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
8. Participants of childbearing potential must agree to use effective contraception prior to study enrollment and for at least 6 months after completion of study treatment. Participants who become pregnant or suspect pregnancy must notify the investigator immediately.

Exclusion Criteria:

1. History within 1 year prior to signing the informed consent form of any of the following:

   * New York Heart Association (NYHA) Class III or IV heart failure;
   * Myocardial infarction;
   * Cardiac angioplasty or stent placement;
   * Unstable angina;
   * Other clinically significant symptomatic cardiac disease;
2. Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy.
3. History of other malignancies within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after curative surgery.
4. Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections).
5. Evidence of active viral or infectious disease as follows:

   * Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection;
   * Positive hepatitis C virus (HCV) antibody with detectable HCV RNA;
   * Positive human immunodeficiency virus (HIV) antibody;
   * Positive Treponema pallidum particle agglutination assay (TPPA).
6. Participation in another clinical trial within 4 weeks prior to signing the informed consent form, or if the time from the last dose of an investigational drug to informed consent is less than 5 half-lives of that drug (whichever is longer).
7. History of severe allergic reactions to biologic products.
8. Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment.
9. Pregnant or breastfeeding women; women planning to become pregnant within 2 years after cell infusion; or male participants whose partners plan to become pregnant within 2 years after cell infusion.
10. Any condition that, in the opinion of the investigator, may increase the participant's risk or interfere with study participation or interpretation of study results.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Similar studies

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

• 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

• CT0596 CAR-T in relapsed/refractory multiple myeloma: a phased dose-find and efficacy study

  This study tests CT0596 CAR-T cells in adults with relapsed/refractory multiple myeloma who have already had multiple prior treatments.

  Recruiting Phase 1/2 UCARsgen Biotech Limited · Suzhou, Jiangsu and 1 other locations · NCT07760454

• Metabolically armed BCMA CAR-T (Meta10-BCMA) for relapsed or refractory plasma cell neoplasms

  This treatment tries a metabolically modified BCMA-targeted CAR-T cell therapy for adults with relapsed or refractory multiple myeloma, plasma cell leukemia, or AL amyloidosis who have had at least three prior therapies.

  Recruiting Early Phase 1 Anhui Provincial Hospital · Hefei, Anhui · NCT07085559

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

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.