CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed/refractory hematologic malignancies.
Who can participate
Age range
14 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects diagnosed with relapsed/refractory lymphoma/leukemia:
. Relapsed/refractory T-cell malignant lymphoma: patients who have not remission and recurrence after at least 2 courses of standardized second-line or above treatment (including hematopoietic stem cell transplantation).
. Relapsed/refractory T-cell acute lymphocytic or myeloid leukemia meeting any of the following criteria:
. Bone marrow flow cytometry detected tumor cells as CD7 and/or extramedullary lesions with a clear diagnosis of CD7 by pathological immunohistochemistry at the time of enrollment screening;
. If tumor cells are detected in peripheral blood during enrollment screening, flow cytometry must be used to detect that the immunophenotype of tumor cells on the surface of tumor cells is both negative for CD4 and CD8. If the immunophenotype on the surface of peripheral blood tumor cells is not CD4 and CD8 negative, the proportion of peripheral blood tumor cells must be ≤1%;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
Timeframe: up to one month after the CAR-T infusion
2
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
Timeframe: one month and three month after the CAR-T infusion
3
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
Timeframe: one month and three month after the CAR-T infusion
. Expected survival greater than 3 months from the date of signing the informed consent form;
. Subjects with a performance status of 0\~2 in the Eastern Cooperative Oncology Group (ECOG) score;
. 14 years old≤ age ≤ 75 years old, male or female;
Exclusion criteria
. One of the following cardiac criteria occurs: atrial fibrillation; Myocardial infarction within the past 12 months; Prolonged QT syndrome or secondary QT Extension, to be determined by the researcher. Echocardiography with LVSF\<30% or LVEF\<50%; Clinically significant pericardial effusion; Heart function Incomplete NYHA III or IV (confirmed by echocardiography within 12 months after treatment);
. Active GVHD;
. Have a history of severe pulmonary dysfunction;
. Merge other advanced malignant tumors;
. Combination of severe or persistent infections that cannot be effectively controlled;
. Combination of severe autoimmune diseases or congenital immunodeficiency;
. Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBV-DNA ≥ 500 IU/ml and abnormal liver function\] or anti hepatitis C virus Positive for HCV Ab, HCV-RNA above the detection limit of the analytical method, and abnormal liver function;
. Human immunodeficiency virus (HIV) infection or syphilis infection;