Status:
NOT_YET_RECRUITING
CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms
Lead Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Conditions:
Relapsed or Refractory Plasma Cell Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR19BCMA CAR-T cell. 20 subjects with relapsed or refractory CD19/ BCMA positive positive plasma cell neo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 25 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06986434
Start Date
August 26 2025
End Date
August 25 2028
Last Update
September 3 2025
Active Locations (1)
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1
the Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, China