In Vivo BCMA/GPRC5D Dual CAR-T Therapy for Relapsed/Refractory Plasma Cell Neoplasms

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 is an early-phase, single-arm study evaluating the safety and preliminary activity of in vivo BCMA/GPRC5D-targeted tandem dual CAR-T cells (SL4903) in patients with relapsed or refractory plasma cell neoplasms. The study uses a dose-escalation design to monitor adverse events after infusion, focusing on cytokine release syndrome, neurotoxicity, hematologic, and organ toxicities, while also collecting data on response rates and survival metrics. Secondary aims explore CAR-T cell kinetics and clonal changes in plasma cells during and after treatment. Efficacy endpoints include overall response rate, event-free survival, overall survival, progression-free survival, duration of complete remission, relapse rate, and mortality. Exploratory analyses may help understand how the CAR-T cells behave in vivo over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
* Diagnosis of relapsed or refractory plasma cell neoplasms meeting the following criteria:

  1. Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry;
  2. Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria)
* Age 18 to 75 years (inclusive), male or female.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Life expectancy \> 3 months from the date of informed consent.
* Hemoglobin (HGB) ≥ 60 g/L (transfusion allowed).
* Adequate organ function (hepatic, renal, cardiac, and pulmonary):

  1. Creatinine ≤ 2 × ULN;
  2. Left ventricular ejection fraction (LVEF) ≥ 50%;
  3. Oxygen saturation \> 90%;
  4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.
* Willingness to use highly effective contraception from signing of informed consent until 1 year after SL4903 infusion.

Exclusion Criteria:

* Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \< 50%.
* History of severe pulmonary impairment.
* Concurrent diagnosis of another active malignancy.
* Uncontrolled active infection.
* History of severe autoimmune disease or primary immunodeficiency.
* Active hepatitis (defined as HBV DNA or HCV RNA above the lower limit of detection).
* Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or active syphilis.
* History of severe hypersensitivity to biological products (including antibiotics).
* Allogeneic hematopoietic stem cell transplant recipients with ongoing acute graft-versus-host disease (GVHD) despite discontinuation of immunosuppressive therapy for at least one month prior to screening.
* Any other severe comorbidities or laboratory abnormalities that, in the investigator's opinion, would increase the risk to the subject or interfere with study results, rendering the subject unsuitable for participation.
* Pregnant or breastfeeding women (including women of childbearing potential who are pregnant or lactating).

Where it's running

• Chinese PLA General Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Liping DOU — Chinese PLA General Hospital
• Study coordinator: Yu ZHAO
• Email: zhaoyu301@126.com
• Phone: 13601051848

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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.