Last updated: April 17, 2022
Sponsor: He Huang
Overall Status: Active - Recruiting
Phase
1
Condition
Lymphoma
Treatment
N/AClinical Study ID
NCT05340829
FT400-006
Ages 18-65 All Genders
Study Summary
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
ChinaActive - Recruiting
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