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Trial Title:
Universal CAR-T Cells Targeting AML
NCT ID:
NCT05995041
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
AML
Universal CAR T
CD33, CD123, CD38, CLL-1
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells
Description:
Infusion of CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells
Arm group label:
Multiple universal CAR T cells to treat AML
Summary:
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of
universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with
relapsed and refractory AML. The study also aims to learn more about the function of the
universal CAR T cells and their persistency in AML patients.
Detailed description:
Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of
myeloblasts that grow in the bone marrow and interferes with the generation of normal
blood cells.Over the past years, several groups have demonstrated that CLL1, CD33, CD38
and CD123 are potential AML targets. CLL-1 (C-type lectin-like molecule-1) is a
transmembrane glycoprotein, which is overexpressed in leukemic stem cells but absent in
normal hematopoietic stem cells, suggesting that CLL-1 can be a promising target for
targeted AML therapy. Although CAR-T cells have shown impressive anti-leukemic effect in
B cell disease, CAR-T treatment for AML has proven to be more difficult. One of the
reasons is because AML patients often has highly suppressed bone marrow function, and it
is often difficult to obtain good quality of T cells for CAR-T preparation. In addition,
AML progression can be acute and rapid, which can outpace the CAR-T expansion, and the
time-consuming CAR-T manufacture process makes it more difficult to treat AML with
autologous source of T cells By using universal type of CAR-T cells, the product can be
supplied off-the-shelf without being customized from individual patients. In addition,
the immediate availability means that patients with short disease remission time under
severe bone marrow suppression may get a chance to be treated with CAR-T cells to achieve
disease remission. In addition, those patients who suffer from long-term
immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would
have the option of treatment with the universal CAR-T cells.
The purpose of this study is to assess the feasibility, safety and efficacy of several
AML-specific universal CAR-T products. Another goal is to learn more about the function
of the universal CAR T cells and their persistency in the patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age older than 6 months.
2. Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by
immuno-histochemical staining or flow cytometry.
3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3
months.
4. Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%,
creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤
2.0mg/dL.
5. Hgb≥80g/L.
6. No cell separation contraindications.
7. Abilities to understand and the willingness to provide written informed consent.
Exclusion Criteria:
1. Sever illness or medical condition, which would not permit the patient to be managed
according to the protocol, including active uncontrolled infection.
2. Active bacterial, fungal or viral infection not controlled by adequate treatment.
3. Known HIV or active hepatitis C virus (HCV) infection.
4. Pregnant or nursing women may not participate.
5. Use of glucocorticoid for systemic therapy within one week prior to entering the
trial.
6. Previous treatment with any gene therapy products.
7. The bone marrow AML burden (MRD) is above 50%.
8. Patients, in the opinion of investigators, may not be able to comply with the study.
Gender:
All
Minimum age:
6 Months
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shenzhen Geno-Immune Medical Institute
Address:
City:
Shenzhen
Zip:
518000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lung-Ji Chang, Ph.D
Phone:
86-0755-8672 5195
Email:
c@szgimi.org
Start date:
October 31, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shenzhen Geno-Immune Medical Institute
Agency class:
Other
Source:
Shenzhen Geno-Immune Medical Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05995041
