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

Launched by CHINESE PLA GENERAL HOSPITAL · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called CAR19BCMA CAR-T cell therapy for people with certain types of plasma cell cancers that have come back or have not responded to previous treatments. These cancers include multiple myeloma, plasma cell carcinoma, plasma cell leukemia, and a condition called light chain amyloidosis. The goal of the study is to see if this treatment is safe and if it can help control the disease in patients who have already tried several other treatments without success.

People who might be eligible to join are adults aged 18 to 75 with a confirmed diagnosis of plasma cell cancer that tests positive for specific markers called CD19 or BCMA. They must have already undergone multiple rounds of treatment but still have active disease. Participants need to be in reasonably good health overall, with certain heart, liver, and kidney functions within safe limits, and must agree to use birth control during the study and for a year afterward. Those with serious infections, other advanced cancers, or certain immune problems may not be eligible. Since this is an early-phase trial, the main focus will be on safety and how well the treatment works. If you or a loved one fit these criteria and are interested in new treatment options, this study might be a possibility once it begins recruiting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:
• • 1.1 Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.
• • 1.2 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.
• • 1.3 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.
• • 2. Age 18-75 years,
• • 3. no gender restrictions;
• • 4. ECOG score ≤ 2 points;
• • 5. Expected survival period is not less than 3 months;
• • 6. HGB≥60g/L;
• • 7. Liver and kidney function and cardiopulmonary function meet the following requirements: (1) Creatinine ≤ 2× ULN; (2)left ventricular ejection fraction≥50%; (3) Oxygen saturation \>90%; (4)Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN;
• • 8. Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion.
• Exclusion Criteria:
• • 1. Severe heart failure with left ventricular ejection fraction \<50%;
• • 2. A history of severe lung function impairment; Combined with other advanced malignant tumors;
• • 3. Complicated with severe infection that could not be effectively controlled;
• • 4. Severe autoimmune disease or congenital immune deficiency;
• • 5. 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;
• • 6. History of severe allergy to biological products (including antibiotics);
• • 7. Allogeneic hematopoietic stem cell transplant patients who still have an acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants;
• • 8. 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;
• • 9. Female patients (those with fertility) are in pregnancy or lactation.