Evaluate the Safety and Effect of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lymph… (NCT05340829) | Clinical Trial Compass
UnknownPhase 1
Evaluate the Safety and Effect of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia
China18 participantsStarted 2022-03-18
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Age 18-65.
* Patients with AIDS-associated B-cell lymphoma/leukemia, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma tranferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and leukemia.
* At least received first line treatment.
* Had available evaluation lesion.
* ECOG(Eastern Cooperative Oncology Group) ≤ 1 or Karnofsky ≥ 60%.
* Had good organic function within 4 weeks before enrollment: Alanine aminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)\<2.0 mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanavir or indinavir, TBIL\<3.0 mg/dL can be enrolled.); Left ventricular ejection fraction(LVEF)≥40%; Absolute neutrophile counts≥1000/mm3; thrombocyte≥30000/mm3; Serum creatinine≤1.5×ULN or creatinine clearance\>30 mL/min/1.73 m2.
* Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before.
* Confirmed Human immunodeficiency virus(HIV)-1 infection.
* HIV virus loading \< 200 copy/ml within 4 weeks before screening.
* CD4+T cell counts \>50 cells/mm3 within 4 weeks before screening.
* Patients with TBIL≤ 1.5 mg/dL, Aspartate aminotransferase(AST) and ALT ≤ 3×ULN, and hepatitis B virus(HBV) DNA \<2000 IU/ml can be enrolled for HBV positive patients(defined as hepatitis B virus surface antigen(HBsAg)…
What they're measuring
1
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