uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called uCD7 CAR-T cell therapy for adults with certain types of blood cancers that have not responded to other treatments or have come back after treatment. Specifically, it focuses on patients with relapsed or refractory acute myeloid leukemia (AML) or T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) whose cancer cells have a marker called CD7. The goal is to see if this therapy is safe and how well it works by giving patients different doses of these specially modified immune cells through an IV.

Adults between 18 and 70 years old with confirmed CD7-positive AML or T-ALL/LBL who have not responded to standard treatments or have relapsed may be eligible. To join, patients need to meet certain health criteria, like having enough healthy heart and kidney function, and must agree to participate voluntarily. During the trial, participants will receive the uCD7 CAR-T cells and be closely monitored for side effects and treatment response. This study is currently recruiting patients and is taking place at a single medical center. It’s important to note that people with certain conditions, such as other specific blood cancers, serious infections, or heart problems, may not qualify. Participants should also be aware of pregnancy restrictions due to unknown effects on unborn babies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 and \<70 years, regardless of gender;
• • 2. T-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and T-cell Lymphoma Clinical Practice Guidelines (2020.v1);
• • 3. Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;
• • 4. Cytology confirmed that the tumor cells were CD7 positive.
• • 5. Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
• 6. Complies with the diagnosis of relapsed/refractory AML, including any of the following conditions according to China Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2021 Edition):
• • 1. Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy;
• • 2. CR after consolidation chemotherapy, relapse within 12 months;
• • 3. Relapse 12 months after remission but ineffective after conventional chemotherapy;
• • 4. 2 or more relapses;
• • 5. Relapse after hematopoietic stem cell transplantation.
• 7. Meet the diagnosis of relapsed/refractory T-ALL/LBL, including any of the following:
• • 1. Primary refractory patients who have not achieved complete response after two cycles of standard chemotherapy, or patients who have not achieved complete response after multi-line rescue chemotherapy;
• • 2. Relapse within \<12 months after complete remission or ≥12 months after complete remission and fail to achieve complete remission induced by 1 or more cycles of standard treatment;
• • 3. Relapse after hematopoietic stem cell transplantation or relapse after CAR-T therapy at the same target;
• • 8. Complies with diagnosis of other relapsed/refractory CD7 positive hematologic malignancies
• • 9. Creatine clearance \>60ml/min (Cockcroft and Gault formula); serum total bilirubin ≤3 times the upper limit of normal, serum ALT and AST ≤5 times the upper limit of normal range for patients without liver invasion;
• • 10. Echocardiography showing left ventricular ejection fraction (LVEF) ≥50%;
• • 11. Pulse oxygen saturation ≥92%;
• • 12. The estimated survival time is more than 3 months;
• • 13. ECOG score 0-2;
• • 14. Subjects or their legal guardians voluntarily participate in this trial and sign the informed consent form.
• Exclusion Criteria:
• Subjects who met any of the following criteria were excluded from the study:
• • 1. acute promyelocytic leukemia (APL);
• • 2. Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
• • 3. Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
• 4. Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:
• • 1. Systemic chemotherapy (except for pretreatment) within 1 week;
• • 2. For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening;
• • 3. Received donor lymphocyte infusion (DLI) within 6 weeks;
• • 5. Presence of uncontrolled, serious, active infection at screening;
• • 6. Patients with a history of serious heart disease, including: severe cardiac insufficiency (subjects with cardiac insufficiency of Class III or IV according to the New York Heart Association (NYHA) cardiac function classification standard), myocardial infarction within 12 months or cardiac angioplasty or stenting, unstable angina pectoris, ECG indicating significant QT interval prolongation (\>480ms) or serious arrhythmia judged by the investigator;
• • 7. Previous craniocerebral trauma, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral vascular hemorrhagic disease and other medical history, and within six months of the need for drug treatment;
• • 8. Patients with hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis antibody test positive, EBER positive or EBV copy number greater than the upper limit of normal at screening;
• • 9. Patients who must use steroid hormones during CAR-T infusion (except for local or inhaled steroid hormones); subjects who are receiving systemic steroid therapy before screening and need long-term systemic steroid therapy during treatment according to the investigator's judgment (except for inhaled or local use);
• • 10. Subjects with autoimmune diseases requiring treatment, immunodeficient subjects, or subjects requiring immunosuppressive treatment;
• • 11. Patients with acute graft-versus-host disease (GvHD) or moderate-to-severe chronic GvHD within 4 weeks prior to screening;
• • 12. Patients with a history of allergy to any component of cell products;
• • 13. Pregnant, lactating females, and subjects (male or female) of childbearing potential who are unable to use effective contraception within 1 year after cell infusion; male subjects who plan to become pregnant within 1 year after cell infusion; female subjects or partners who plan to become pregnant within 1 year after cell infusion;
• • 14. Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the trial.