CAR-T for Autoimmune Hemolytic Anemia Patients Who Have Failed Three or More Lines of Therapy (NCT06212154) | Clinical Trial Compass
UnknownPhase 1
CAR-T for Autoimmune Hemolytic Anemia Patients Who Have Failed Three or More Lines of Therapy
China13 participantsStarted 2024-01-20
Plain-language summary
To Evaluate the Safety and Efficacy of ThisCART19A for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms.
* Male or female age ≥ 12 years.
* ECOG performance status ≤2.
* Diagnosis of warm antibody hemolytic anemia (AIHA), cold AIHA, mixed AIHA or Evans syndrome.
* Hemoglobin\<100g/L.
* Failure or intolerance to at least 3 lines of therapy, including glucocorticoids, rituximab, cyclophosphamide, azathioprine, fludarabine, cyclosporine, mycophenolate mofetil, Bruton's tyrosine kinase inhibitors, splenectomy.
* Laboratory tests of adequate organ function: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥40ml/min; Absolute neutrophil count (ANC) ≥1.0×10\^9/L (growth factors such as granulocyte colony-stimulating factor \[G-CSF\] were not received within 7 days before the screening period); Left ventricular ejection fraction (LVEF) ≥45%; Blood oxygen saturation (SpO2) ≥92%.
* Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 6-month safety follow-up period. Female subjects of childbearing potential must have a negative Serum HCG test within 7 days before enrollment and not in the lactation period.
Exclusion Criteria:
* Clear diagnosis of lymphoproliferative tumor.
* The platelet count in peripheral blood during the screening period is \<20×10\^9/L.
* Have a history of sev…
What they're measuring
1
The incidence and frequency of treatment-emergent adverse events
Timeframe: Within 6 months
2
Maximal Tolerable Dose(MTD)
Timeframe: Up to 28 days after infusion
Trial details
NCT IDNCT06212154
SponsorInstitute of Hematology & Blood Diseases Hospital, China