A Phase 1 interventional study of ThisCART19A in AIDS Related Lymphoma and Lympholeukemia, sponsored by He Huang. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by He Huang · Phase 1, Interventional, and Treatment
This is an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 18 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →He Huang is the lead sponsor of 21 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive 2×10\^6 cells/kg of ThisCART19A
Biological: ThisCART19A
Patients will receive 3×10\^6 cells/kg of ThisCART19A
Biological: ThisCART19A
Patients will receive 4×10\^6 cells/kg of ThisCART19A
Biological: ThisCART19A
ThisCART19A is a new type CAR-T cells therapy for patients with lymphoma and lympholeukemia
Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Time frame: 28 days
Objective Response rate in patients with AIDS related lymphoma
The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment
Time frame: 12 months
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Track CAR-T cells expansion in patients after infusion
Time frame: 6 months
Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion
Analysis the effect cells and cytokines in patients after infusion
Time frame: 3 months
Analysis the severity and Incidence of Adverse Events in each dose level
Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, the adverse events with special consideration
Time frame: 12 months
Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion
Analysis the Anti-therapeutic antibody and neutralizing antibody level after infusion
Time frame: 24 months
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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He Huang