CD7-positive hematocratic malignancies (priority include for acute T-lymphoblastic leukemia/lymphoma)
Conditions
Interventions
1:PA3-17 infusion
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old (inclusive), male or female; 2. Expected survival time >= 3 months; 3. ECOG performance status of 0-1; 4. Malignant lymphoma diagnosed according to WHO2016 criteria: priority will be given to T-cell acute lymphoblastic leukemia/lymphoma (including early pre-T-cell lymphoblastic leukemia); 5. Subjects with recurrent/refractory T-cell acute lymphoblastic leukemia/lymphoma (including early pre-T-cell lymphoblastic leukemia) who have failed standard treatment or lack effective treatment and meet any of the following criteria: (1) Recurrent: disease recurrence is confirmed after complete response with at least two prior regimens, or after complete response through stem cell transplantation; (2) Refractory: failure to achieve CR (for leukemia patients) or PR (for lymphoma patients) after the last treatment with at least two prior regimens, or failure to achieve response or disease progression after stem cell transplantation; 6. Lymphoid hematologic malignancies diagnosed as CD7 positive by flow cytometry and/or CD7 positive by histopathological immunohistochemistry at screening, with the positive rate of tumor = 30%; 7. For CD7-positive lymphoid hematologic malignancies involving bone marrow and/or peripheral blood, patients with CD4/CD8 double-negative surface immunophenotype of tumor cells as determined by flow cytometry; 8. Liver, kidney and cardiopulmonary function shall meet the following requirements: (1) Creatinine = 45%; (3) Oxygen saturation > 91%; (4) Total bilirubin <= 2 x ULN; ALT and AST <= 2.5 x ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltration or bile duct obstruction) as judged by the investigator, the indicators can be relaxed to <= 5 x ULN; 9. Patients who can understand the trial and have signed informed consents.
Exclusion criteria
Exclusion criteria: 1.Subjects who need to use immunosuppressants; 2.Subjects with malignant tumors other than T-cell hematological malignancies within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical mastectomy; 3.Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA test; positive for syphilis test; 4.Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification >= III), severe arrhythmia; 5.Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment; 6.Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract infection); 7.Pregnant or lactating women, and female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after cell infusion; 8.Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening; 9.Subjects who are receiving systemic steroid therapy within 7 days prior to screening or need long-term use of systemic steroid therapy during treatment as judged by the investigator (except for inhalation or topical use); 10.Subjects who have participated in other clinical studies within 3 months prior to screening; 11.Subjects who have evidence of central nervous system invasion at screening; 12.Conditions not eligible for cell preparation as judged by the investigator; 13.Other conditions considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Efficacy; | — |
Countries
China
Contacts
Public ContactZhang Mingzhi; Huang Xiaojun
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed