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

Launched by AFFILIATED HOSPITAL TO ACADEMY OF MILITARY MEDICAL SCIENCES · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment using CAR19BCMA CAR-T cells for patients with relapsed or refractory plasma cell neoplasms, which are types of blood cancers that have come back after treatment or did not respond to previous therapies. The study aims to see how safe and effective this new treatment is for people who have specific markers in their cancer cells known as CD19 and BCMA.

To join the trial, participants need to be between 18 and 80 years old and have a confirmed diagnosis of certain blood cancers like multiple myeloma or plasma cell leukemia, and they must have already tried at least three different treatments without success. Participants should also be in reasonably good health, with certain tests showing their heart and liver functions are adequate. Those who qualify will receive the CAR-T cell treatment and will be monitored for safety and effectiveness. It's important to note that this trial is not yet recruiting, so interested individuals will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:
• • ①Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.
• • ②Patients 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.
• • ③Patients 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 18-80 years, no gender restrictions; ECOG score ≤ 2 points; Expected survival period is not less than 3 months; HGB≥60g/L; Liver function and cardiopulmonary function meet the following requirements: (1) left ventricular ejection fraction≥50%; (2) Oxygen saturation \>90%; (3)Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN; Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion.
• 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 hepatitis (hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] test results above the lower limit of detection); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; History of severe allergy to biological products (including antibiotics); 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.
• • Female patients (those with fertility) are in pregnancy or lactation.