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

NCT04923919 | Unknown Early Phase 1

• 1 other identifier: BG-CT-19-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of AE after CAR-T infusion

  Incidence of adverse events after CAR-T infusion Data. The records of adverse events (AE) should include: description of AE and all related symptoms, occurrence time, severity, duration, measures taken, final results and outcomes. According to NCI CTC AE 5.0 standard, AE was scored Grade. Safety evaluation indexes include but are not limited to the following contents 1. Any spontaneously reported and all directly observed adverse events; 2. Any abnormal changes in vital signs and physical examination; 3. The abnormal results of laboratory examination, physical examination and blood examination with clinical significance after treatment

  up to 12 months after CAR-T infusion

Secondary Outcomes (5)

• ORR rate

  1month, 2 months, 3months, 6months ,12months after CAR-T infusion

• PFS

  1month, 2 months, 3months, 6months ,12months after CAR-T infusion

• OS

  1month, 2 months, 3months, 6months ,12months after CAR-T infusion

• Change of CAR Copies

  Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion

• Change of CAR-T cell counts

  Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion

Study Arms (1)

Single arm

EXPERIMENTAL

CLL-1 targeting CAR-T treatment

Drug: Anti-CLL1 CART cells

Interventions

Anti-CLL1 CART cells 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.

Also known as: CLL1 CAR-T

Single arm

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Diseased cells were confirmed to express CD123, CLL1 and other targets;
• KPS \> 60 points;
• Expected survival of more than 3 months;
• No gender limitation, age 2-75;
• Patients clinically diagnosed as high-risk type, refractory type of recurrence or not eligible for standard treatment;
• No serious mental disorders;
• 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%;);
• No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program;
• Can cooperate with trial management and follow-up;
• Patients voluntarily participated in the study and signed the informed consent

You may not qualify if:

• History of other malignant tumors;
• Uncontrolled active infection;
• Patients with underlying diseases requiring systemic use of glucocorticoids;
• Acute or chronic GVHD;
• T-cell inhibitor therapy;
• Pregnant and lactating women;
• Patients with active hepatitis B;
• 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.

Sponsors & Collaborators

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

Study Sites (1)

No.212 Daguan Road, Xishan District

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wang Sanbin, Doctor

CONTACT

(86)13187424131; Sanbin1011@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: June 11, 2021
• Study Start: September 14, 2021
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)