Clinical Study of CLL1 CAR-T Cells in the Treatment of Hematological Malignancies

Zhejiang University

Status and phase

Enrolling

Early Phase 1

Conditions

AML

Treatments

Biological: CLL1 CAR T-cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05252572

CLL1-001

Details and patient eligibility

About

Clinical Study on the Safety and Effectiveness of CLL1 CAR-T Cells in the Treatment of CLL1-positive Hematological Malignancies

Full description

Human C-type lectin-like molecule 1 (CLL1) is a type II transmembrane glycoprotein ，CLL1 expression is restricted to bone marrow cells and most AML blasts. In addition, CLL1 is expressed in leukemia stem cells (LSC) but not in hematopoietic stem cells (HSC), may provide a potential therapeutic target for the treatment of AML.The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. The center intends to apply for a clinical trial of CLL1 CAR-T cells to treat CLL1-positive hematological malignancies on the basis of preliminary research.

Enrollment

36 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients is histologically diagnosed with CLL1-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021） 2. The diagnosis is consistent with r/r CLL1 + AML, and includes any of the following conditions:
2. No CR was obtained after 2 courses of standard chemotherapy
3. The first induction was CR, but the duration of CR was less than 12 months
4. No CR was obtained after the first or multiple remedial treatment;
5. Relapse twice or more; 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
  1. No active lung infection, inhaled air oxygen saturation ≥92% 5. The estimated survival time is more than 3 months 6. ECOG score was 0-2 7. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
  Exclusion Criteria:
1. Patients with history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT or severe heart disease; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. The patients with uncontrolled active infection; 5. Active hepatitis B or hepatitis C virus infection; 6. Previous application of gene therapy; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl; 9. Those who suffer from other uncontrolled diseases are not suitable to join the study; 10. HIV infection; 11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.