Clinical trial NCT04923919: Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia
Official title: Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Myeloid Leukemia
Lead sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of AE after CAR-T infusion
timeFrame: up to 12 months after CAR-T infusion
Secondary outcomes:
measure: ORR rate
timeFrame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
measure: PFS
timeFrame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
measure: OS
timeFrame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
measure: Change of CAR Copies
timeFrame: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
measure: Change of CAR-T cell counts
timeFrame: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
Other outcomes:
Locations:
city: Kunming
country: China
facility: No.212 Daguan Road, Xishan District
state: Yunnan
Study officials:
References: