Not Yet RecruitingEarly Phase 1

CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms

China20 participantsStarted 2025-08-01

Plain-language summary

This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:
✓.1 Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.
✓.2 Patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse.
✓.3 Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past \[anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)\], but have failed or experienced relapse.
✓. Age 18-75 years,
✓. no gender restrictions;
✓. ECOG score ≤ 2 points;
✓. Expected survival period is not less than 3 months;

Exclusion criteria

✕. Severe heart failure with left ventricular ejection fraction \<50%;
✕. A history of severe lung function impairment; Combined with other advanced malignant tumors;
✕. Complicated with severe infection that could not be effectively controlled;
✕. Severe autoimmune disease or congenital immune deficiency;
✕. Active viral hepatitis (defined as positive hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] detection, with test results exceeding the lower limit of quantification); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
✕. History of severe allergy to biological products (including antibiotics);
✕. Allogeneic hematopoietic stem cell transplant patients who still have an acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants;
✕. Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study;

What they're measuring

According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.

Timeframe: up to 3 years

According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.

Timeframe: MTD will be determined based on DLTs observed during the first 28 days of study treatment

Trial details

NCT IDNCT07077330

SponsorChinese PLA General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Yi Liu Dr

+86 186 0031 0985 18600310985@163.com

View on ClinicalTrials.gov More Relapsed or Refractory Plasma Cell Neoplasms trials