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

NCT05340829 | Unknown Phase 1

• 1 other identifier: FT400-006
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AIDS Related Lymphoma and Lympholeukemia

Outcome Measures

Primary Outcomes (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

  DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

  28 days

Secondary Outcomes (5)

• Objective Response rate in patients with AIDS related lymphoma

  12 months

• The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion

  6 months

• Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion

  3 months

• Analysis the severity and Incidence of Adverse Events in each dose level

  12 months

• Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion

  24 months

Study Arms (3)

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

EXPERIMENTAL

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

Biological: ThisCART19A

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

EXPERIMENTAL

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

Biological: ThisCART19A

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

EXPERIMENTAL

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

Biological: ThisCART19A

Interventions

ThisCART19A BIOLOGICAL

ThisCART19A is a new type CAR-T cells therapy for patients with lymphoma and lympholeukemia

Patients will receive 4×10^6 cells/kg as dose level 3; ThisCART19A 2×10^6 cells/kg for dose level 1; ThisCART19A 3×10^6 cells/kg as dose level 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• He Huang: lead

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, AIDS-Related

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• He Huang, Doctor

  First hospital affiliated Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Ming Zhang, Doctor

CONTACT

13656674208; mingmingzhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President/Proffessor

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 22, 2022
• Study Start: March 18, 2022
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

CN (1)