NCT07416682
CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms
Recruiting · Early Phase 1 · Affiliated Hospital to Academy of Military Medical Sciences · registry updated 2026-07-13
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.
Inclusion
- The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.
- Clinically diagnosed with high-risk plasma cell neoplasm, meeting any one of the following molecular/cytogenetic or clinical criteria:
- Deletion of the short arm of chromosome 17 (del(17p)) with clonal proportion ≥ 20%, and/or TP53 gene mutation;
- IgH translocation (t(4;14), t(14;16), or t(14;20)) combined with 1q amplification (1q+) and/or deletion of the short arm of chromosome 1 (del(1p32));
- Chromosome 1 abnormalities: monoallelic del(1p32) plus 1q+, or biallelic del(1p32);
- β₂-microglobulin ≥ 5.5 mg/L with normal serum creatinine (\< 1.2 mg/dL).
Exclusion
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) \< 50%.
- History of severe chronic lung disease associated with impaired pulmonary function.
- Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.
- Concurrent severe infection that cannot be effectively controlled with standard therapy.
- Concurrent severe autoimmune disease or congenital immunodeficiency disorders.
- Active viral hepatitis, defined as hepatitis B virus DNA (HBV-DNA) or hepatitis C virus RNA (HCV-RNA) levels above the lower limit of detection (LLOD).