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

He Huang

Status and phase: Unknown; Phase 1

Conditions: AIDS Related Lymphoma and Lympholeukemia

Treatments: Biological: ThisCART19A

Study type: Interventional

Funder types: Other

Identifiers

NCT05340829

FT400-006

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

ThisCART19A 2×10^6 cells/kg for dose level 1

Experimental group

Description:

Patients will receive 2×10\^6 cells/kg of ThisCART19A

Treatment:

Biological: ThisCART19A

ThisCART19A 3×10^6 cells/kg as dose level 2

Experimental group

Description:

Patients will receive 3×10\^6 cells/kg of ThisCART19A

Treatment:

Biological: ThisCART19A

Patients will receive 4×10^6 cells/kg as dose level 3

Experimental group

Description:

Patients will receive 4×10\^6 cells/kg of ThisCART19A

Treatment:

Biological: ThisCART19A