About this trial
This study aims to assess the safety profile of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.
Eligibility criteria
Qualifiers
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.
Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry;
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.
Disqualifiers
Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%.
History of severe pulmonary impairment.
Concurrent diagnosis of another active malignancy.
Uncontrolled active infection.
Trial design
Treatments tested in this trial
- In vivo BCMA/GPRC5D Tandem Dual CAR-T cell
Treatment groups
Locations
Sponsors and collaborators
Liping Dou
Lead sponsor
Chinese PLA General Hospital
Sponsor institution