Actively Recruiting
CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia
Led by City of Hope Medical Center · Updated on 2026-03-05
27
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient or donor's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's or donor's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.
CONDITIONS
Official Title
CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent if appropriate
- Agreed to allow use of archival tissue from diagnostic tumor biopsies or obtained approval for exceptions
- Age 18 years or older
- Karnofsky Performance Scale score of 70 or higher
- Life expectancy of at least 16 weeks at enrollment
- Prior allogeneic transplant allowed if more than 6 months before enrollment
- Confirmed diagnosis of active CD33+ AML, including de novo, secondary, or high risk for recurrence
- Relapsed AML defined as first complete response before recurrence
- Refractory AML defined as no first complete response after induction chemotherapy
- Bone marrow and/or peripheral blood samples available for AML confirmation with CD33 positivity within 90 days
- No contraindications to lymphodepleting agents, steroids, tocilizumab, cetuximab, or the investigational agent
- Total serum bilirubin 2.0 mg/dL or less (up to 3.0 mg/dL if Gilbert syndrome)
- AST and ALT levels 3 times or less the upper limit of normal
- Estimated creatinine clearance 60 mL/min or higher and not on hemodialysis
- Left ventricular ejection fraction 50% or higher within 8 weeks before enrollment
- Oxygen saturation above 92% without oxygen supplementation
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during study and for 6 months after last dose
- Potential donor or stem cell source identified for allogeneic transplantation
- Donor must be the original stem cell donor, HIV negative, with Karnofsky score 70 or higher and documented body weight
You will not qualify if you...
- Prior allogeneic transplant less than 6 months before enrollment
- Use of systemic steroids or immunosuppressants within 28 days before enrollment (some exceptions allowed)
- Active autoimmune disease including graft versus host disease requiring systemic immune suppression within 28 days
- Receiving other investigational agents or dependent on concurrent biological therapy, chemotherapy, or radiation (except Hydrea stopped before lymphodepletion)
- Active systemic antifungal treatment within 8 weeks before enrollment (prophylaxis allowed)
- Grade 2 or higher myelofibrosis on bone marrow biopsy
- Clinically significant or unstable arrhythmia within 2 weeks of screening if undergoing leukapheresis
- Known bleeding disorders like von Willebrand's disease or hemophilia
- Stroke or intracranial hemorrhage within 6 months prior to screening
- Other active malignancy except prior malignancy in complete remission after curative treatment
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- HIV positive or active hepatitis B or C infection within 4 weeks of enrollment
- Pregnant or breastfeeding women
- Any condition judged by investigator to contraindicate participation due to safety concerns
- Inability to comply with study procedures or feasibility concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
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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