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

Last updated: April 17, 2022
Sponsor: He Huang
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT05340829
FT400-006
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-65.
  • Patients with AIDS-associated B-cell lymphoma/leukemia, including but not limited todiffuse 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: Alanineaminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)<2.0mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanaviror indinavir, TBIL<3.0 mg/dL can be enrolled.); Left ventricular ejectionfraction(LVEF)≥40%; Absolute neutrophile counts≥1000/mm3; thrombocyte≥30000/mm3; Serumcreatinine≤1.5×ULN or creatinine clearance>30 mL/min/1.73 m2.
  • Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients whoreceived 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, andhepatitis B virus(HBV) DNA <2000 IU/ml can be enrolled for HBV positivepatients(defined as hepatitis B virus surface antigen(HBsAg) positive and hepatitis Bcore(HBc)-total positive ) and hepatitis C virus(HCV) positive patients(defined as HCVantibody positive) . Patients with cirrhosis are excluded.
  • Hepatitis B core antibody(HBcAb) positive patients enrolled in this trial have totaking anti-HBV drugs during the whole research.

Exclusion

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 hereditarydiseases.
  • Imaging confirmed the presence of central nervous system involvement(including primaryand 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. Orsystemic disease requiring long-term use of immunosuppression drugs.
  • Excluded the patients received Influenza vaccinations within 2 weeks prior tolymphodepletion (Received Severe Acute Respiratory Syndrome-Corona virusdisease(SARS-COV)19 vaccines could be included. Received inactivated, live/non-liveadjuvant vaccines could be enrolled).
  • Excluded women who are in pregnant or lactating, and female subjects or partners whoplan to be pregnant within 1 year after infusion. Male subjects planning pregnancywithin 1 year after infusion should be excluded.

Study Design

Total Participants: 18
Study Start date:
March 18, 2022
Estimated Completion Date:
April 30, 2024

Connect with a study center

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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