Evaluate the Safety and Effect of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    18
  • sponsor
    He Huang
Updated on 3 May 2022

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.

Details
Condition AIDS Related Lymphoma and Lympholeukemia
Treatment ThisCART19A
Clinical Study IdentifierNCT05340829
SponsorHe Huang
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

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) positive and hepatitis B core(HBc)-total positive ) and hepatitis C virus(HCV) positive patients(defined as HCV antibody positive) . Patients with cirrhosis are excluded
Hepatitis B core antibody(HBcAb) positive patients enrolled in this trial have to taking anti-HBV drugs during the whole research

Exclusion Criteria

Known for allergic to the preconditioning measures
Uncontrollable bacterial, fungal, viral infection before enrollment
Patients with pulmonary embolism within 3 months prior enrollment
Intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases
Imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases
Receive allogeneic hematopoietic stem cell transplantation
Systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. iIntermittent use of topical, inhaled or intranasal steroids recently or currently. Or systemic disease requiring long-term use of immunosuppression drugs
Excluded the patients received Influenza vaccinations within 2 weeks prior to lymphodepletion (Received Severe Acute Respiratory Syndrome-Corona virus disease(SARS-COV)19 vaccines could be included. Received inactivated, live/non-live adjuvant vaccines could be enrolled)
Excluded women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after infusion. Male subjects planning pregnancy within 1 year after infusion should be excluded
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