A single-arm, unblinded clinical study of safety and efficacy of CLL1/+CD33 CAR T cells in patients with acute myeloid leukemia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200058020

Enrollment

Unknown

Registered

2022-03-26

Start date

2022-04-01

Completion date

Unknown

Last updated

2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukemia

Interventions

Treatment group:Inject CAR T cells

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. The patient or his legal guardian volunteered to be the subject and signed the informed consent; 2. Aged 1 to 18 years; 3. Acute myeloid fine leukemia (AML) confirmed by pathology, histology and flow cytometry as CLL1 and CD33-labeled positive (including secondary patients) with recurrence during chemotherapy, or primary drug resistance, or hematologic recurrence after discontinuation of chemotherapy without complete hematology after 1 course of chemotherapy, remission (NCCN,2015.2); 4. The patient's main tissues and organs function well: (1) Liver function: ALT/AST =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >=40%; 5. The patient's peripheral shallow venous blood flow is smooth, which can meet the requirements of intravenous drip and mononuclear cell collection operation; 6. Patients' ECOG score was 0-2 (Karnofsky score >=60).

Exclusion criteria

Exclusion criteria: 1. Patients had an uncontrollable infectious disease within 4 weeks prior to enrollment; 2. Active hepatitis B/C virus; 3. Hiv-infected patients with treponema pallidum positive; 4. Pathological diagnosis of primary tumors other than acute myeloid leukemia; 5. Suffering from a serious autoimmune disease or immunodeficiency disease; 6. The patient is allergic to antibodies or cytokines and other macromolecular biological drugs; 7. Pregnant or lactating patients; 8. Patients considered ineligible for study for other reasons.

Design outcomes

Primary

Measure	Time frame
Safety and Efficacy;Overall Survival;	—

Secondary

Measure	Time frame
Relapse Free Survival ;Event Free Survival;	—

Countries

China

Contacts

Public ContactShen Shuhong

Shanghai Jiaotong University School of Medicine Affiliated Shanghai Children's Medical Center

shenshuhong@scmc.com.cn+86 21 38626161-82055

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026