Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia

NCT ID: NCT04923919

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2024-12-05

Brief Summary

Researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells.The safety of CAR T therapy was evaluated by observing adverse events after cell therapy;The efficacy of CAR-T therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the pharmacokinetics (PK) of CAR T cells.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

CLL-1 targeting CAR-T treatment

Group Type: EXPERIMENTAL

Anti-CLL1 CART cells

Intervention Type: DRUG

In this study, patients with acute myeloid leukemia were treated with autologous anti-CLL1 CAR T cells by a single, intravenous infusion.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the efficacy of CAR T cells.

Interventions

Anti-CLL1 CART cells

In this study, patients with acute myeloid leukemia were treated with autologous anti-CLL1 CAR T cells by a single, intravenous infusion.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the efficacy of CAR T cells.

Intervention Type: DRUG

Other Intervention Names

CLL1 CAR-T

Eligibility Criteria

Inclusion Criteria

1. The diagnosis of myeloid leukemia was clear;Refractory treatment was defined as: (1) 2 patients who did not achieve partial remission after treatment with standard induced remission regimens.② The patients who relapsed within 6 months after the first remission were also called early recurrence.③ The failure relapsed 6 months after the initial response, but was retreated with the original induced response regimen.(4) multiple relapse.Relapse is defined as: patients who achieve complete remission after treatment, more than 5% of leukemia cells in the bone marrow, also known as intramedullary recurrence;Or the presence of leukaemia outside the bone marrow, also known as extramedullary relapse (usually in the central nervous system, testicular leukemia is the most common);

2. Diseased cells were confirmed to express CD123, CLL1 and other targets;

3. KPS > 60 points;

4. Expected survival of more than 3 months;

5. No gender limitation, age 2-75;

6. Patients clinically diagnosed as high-risk type, refractory type of recurrence or not eligible for standard treatment;

7. No serious mental disorders;

8. Sufficient heart, liver and renal function (a. Liver function: ALT/AST < 3 times upper limit of normal value (ULN) and bilirubin ≤34.2μmol/L;B. Renal function: creatinine < 220μmol/L;C. Lung function: indoor oxygen saturation ≥95%;D. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%;);

9. No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program;

10. Can cooperate with trial management and follow-up;

11. Patients voluntarily participated in the study and signed the informed consent

Exclusion Criteria

1. History of other malignant tumors;

2. Uncontrolled active infection;

3. Patients with underlying diseases requiring systemic use of glucocorticoids;

4. Acute or chronic GVHD;

5. T-cell inhibitor therapy;

6. Pregnant and lactating women;

7. Patients with active hepatitis B;

8. Other conditions considered by the investigator to be inappropriate for the study (HIV infection, intravenous drug addiction, etc.), or other conditions that may affect the analysis of the results of the clinical study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

No.212 Daguan Road, Xishan District

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Sanbin, Doctor

Role: CONTACT

Sanbin1011@163.com

(86)13187424131

Other Identifiers

BG-CT-19-005

Identifier Type: -

Identifier Source: org_study_id