Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies

Inclusion Criteria

• •1.Subjects with CD5 positive B-cell lymphomas must meet the diagnostic criteria from National Comprehensive Cancer Network (NCCN) guidelines for B-Cell Lymphomas (2020.V1) and have CD5 expression on lymphoma cells (results within 60 days before informed consent signing are acceptable if current clinical condition is not suitable for sampling, and the investigator will judge whether the test results from other hospitals are acceptable and whether they can be enrolled); according to Lugano 2014 criteria, patients with B-cell lymphomas have at least one measurable lesion with the longest diameter ≥ 1.5 cm or bone marrow involvement detected by flow cytometry .
• •Including:
• •1. Chronic lymphocytic leukemia/small lymphocytic lymphoma: any BTK inhibitor have been given for at least 6 months and the treatment has failed (SD or PD).
• •2. Mantle cell lymphoma (MCL): patients with MCL must have relapsed/refractory diseases after receiving at least one treatment regimen. Previous treatment must include chemotherapy with anthracyclines or bendamustine, anti-CD20 monoclonal antibody, and any BTK Inhibitor therapy.
• •3. Diffuse large B-cell lymphoma: patients with diffuse large B-cell lymphoma who have failed or relapsed after at least two lines of therapy (a standard chemotherapy and a rescue chemotherapy); and meet one of the following conditions: a. unable to receive autologous hematopoietic stem cell transplantation (autoHSCT); b. refuse to receive autoHSCT; c. relapse after autoHSCT.
• •2.Subjects with CD5 positive peripheral T-cell lymphomas (PTCLs) are diagnosed according to criteria from World Health Organization classification for tumors of the hematopoietic and lymphoid tissues (2016 Edition) and have CD5 expression on lymphoma cells (results within 60 days before informed consent signing are acceptable if current clinical condition is not suitable for sampling, and the investigator will judge whether the test results from other hospitals are acceptable and whether they can be enrolled); according to Lugano 2014 criteria, patients with T-cell lymphomas must have at least one measurable lesion with the longest diameter ≥ 1.5 cm and no bone marrow involvement confirmed by flow cytometry and gene rearrangement (TCR/IGH) tests (and PET-CT results, if any, that must indicate no increased bone marrow metabolism); patients must fail or relapse after at least one line of therapy; including but not limited to the following PTCLs:
• •1. Peripheral T cell lymphoma - not otherwise specified (PTCL-NOS)
• •2. Angioimmunoblastic lymphoma
• •3. ALK negative anaplastic large cell lymphoma
• •4. Extranodal NK/T cell lymphoma
• •5. Enteropathy-associated T-cell lymphoma
• •6. Large granular T lymphocyte leukemia
• •7. Adult T cell leukemia
• •3.Age ≥18 and ≤70 years old, regardless of gender.
• •4.Expected life expectancy ≥12 weeks.
• •5.Serum total bilirubin ≤ 37.2 μmol/L (Gilbert syndrome patients ≤ 3.0 ULN, direct bilirubin ≤ 1.5 ULN), estimated glomerular filtration rate eGFR (CKD-EPI) ≥ 30 ml/min/1.73m2, alanine aminotransferase and aspartate aminotransferase less than 2.5 times the upper limit of normal range.
• •6.ECOG score 0-1 points.
• •7.Echocardiography suggests left ventricular ejection fraction (LVEF) ≥50%; blood oxygen saturation \>91%.
• •8.After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CAR T cell infusion (excluding contraception safety periods). A negative pregnancy test must be obtained for female subjects.
• •Subjects must provide written informed consent before the study begin.