Actively Recruiting
Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory/Relapsed Acute Myeloid Leukemia
Led by Essen Biotech · Updated on 2024-11-12
85
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new treatment using chimeric antigen receptor T cells (CAR-T) targeting CD33 and CD123 in patients with relapsed or refractory Acute Myelocytic Leukemia (AML). This open, single-arm clinical trial explores a multiple CAR T-cell therapy approach, aiming to understand how these immune cells function and persist in AML patients. The study focuses on assessing safety, including monitoring for cytokine storm and other side effects, along with disease response after treatment. Participants will receive chemotherapy drugs fludarabine phosphate and cyclophosphamide intravenously over several days as preparatory treatment. Following this, they will be given an infusion of CD33/123 CAR T cells intravenously on day 0. If patients respond positively to the initial CAR T-cell infusion without severe side effects and have enough cells available, they may receive two or three additional doses of the CAR T cells. This regimen is designed to enhance the body's immune response against AML cells. During the study, participants will undergo various assessments including laboratory tests to monitor bone marrow, liver, kidney function, and overall health status. Researchers will track the occurrence and severity of dose-limiting toxicities within 28 days after chemotherapy and CAR T-cell infusion. The trial also measures the success rate of manufacturing and expanding the CAR T cells. Participants' progress will be closely observed through these evaluations to understand treatment safety and effects over time.
CONDITIONS
Brief Title
Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with acute myeloid leukemia who voluntarily signed informed consent
- Age older than 6 months
- Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry
- Karnofsky performance status (KPS) score higher than 80
- Life expectancy greater than 3 months
- Adequate bone marrow, liver, and renal function including cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 times upper limit of normal, AST and ALT ≤ 3 times upper limit of normal, total bilirubin ≤ 2.0 mg/dL
- Hemoglobin ≥ 80 g/L
- No cell separation contraindications
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Severe illness or medical condition preventing patient management according to protocol, including active uncontrolled infection
- Active bacterial, fungal, or viral infection not controlled by treatment
- Known HIV, hepatitis B virus, or hepatitis C virus infection
- Pregnant or nursing women
- Use of systemic glucocorticoids within one week prior to trial entry
- Patients unable to comply with the study as judged by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days for initial treatment and possible additional doses
Participants receive chemotherapy preparatory drugs followed by infusion of CD33/123 CAR T cells. Additional doses of CAR T cells may be given depending on response and availability.
Multiple visits over approximately 4 weeks including chemotherapy and CAR T cell infusion days
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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