CD33-CAR T Cell Therapy for Recurrent or Refractory Acute Myeloid Leukemia
This study is testing a new treatment called anti-CD33 CAR T-cells for adults with acute myeloid leukemia (AML) that has come back or isn't responding to other treatments. CAR T-cell therapy involves taking your own immune cells (T cells), modifying them in the lab to better fight cancer, and then giving them back to you. Before receiving the CAR T-cells, you will undergo lymphodepletion therapy. Researchers want to see how safe this treatment is, what side effects it might cause, and if it can reduce the amount of leukemia in your body. The study aims to enroll 27 participants and is currently unclear about its recruitment status.
- Study design
- This is a dose-escalation study, meaning different groups of participants will receive increasing doses of the treatment. It plans to enroll 27 participants.
- What's involved
- You would undergo lymphodepletion therapy before receiving anti-CD33 CAR T-cells intravenously. Some participants might receive additional CAR T-cells if their AML persists.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for side effects for up to 1 year after your last CAR T-cell infusion. Researchers will also check for measurable residual disease for up to 15 years after treatment.
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NCT05672147
CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~27 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Anti-CD33 CAR T-cellsLymphodepletion Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants who achieve measurable residual disease (MRD)
Measured over Up to 15 years post study treatment
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Karamjeet S Sandhu · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening, while the request for a translated full consent is processed
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with Study principal investigator (PI) approval
Age: \>= 18 years
Karnofsky Performance Scale (KPS) \>= 70
Life expectancy \>= 16 weeks at the time of enrollment
Prior allogeneic transplant allowed if \> 6 months prior to study enrollment
Participant must have a confirmed diagnosis of active CD33+ AML de novo, or secondary OR participants who are at a high risk for disease recurrence
Relapsed AML is defined as patients that had a first complete response (CR) before developing recurrent disease (increased bone marrow blasts)
Refractory AML is defined as patients that have not achieved a first CR after induction chemotherapy. For patients with AML evolving from myelodysplastic syndrome, they should have completed at least one cycle of induction chemotherapy
Research participants must have bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML
CD33 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry. Cytogenetics, flow cytometry, and molecular studies (such as FLT-3 status) will be obtained as per standard practice
Research participants who are at a high risk of disease recurrence, they must have historical bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML
No known contraindications to lymphodepleting agents, steroids, tocilizumab and/or cetuximab, or the investigational agent
Total serum bilirubin =\< 2.0 mg/dL
Participants with Gilbert syndrome may be included if their total bilirubin is =\< 3.0
Aspartate aminotransferase (AST) =\< 3 x the upper limit of normal (ULN)
Alanine aminotransferase (ALT) =\< 3 x ULN
Estimated creatinine clearance of \>= 60 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis
Left ventricular ejection fraction \>= 50% within 8 weeks before enrollment
Oxygen (O2) saturation \> 92% not requiring oxygen supplementation
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Research participants must have a potential donor or stem cell source identified for allogeneic transplantation, either related (7/8 or 8/8 allele matched or haploidentical)
DONOR: The identified donor must be the original donor whose stem cells were used for the research participant's allogeneic hematopoietic stem cell transplantation (alloSCT)
DONOR: The donor must be HIV negative
DONOR: KPS \>= 70
DONOR: Documented body weight
Exclusion
Prior allogeneic transplant if \< 6 months prior to enrollment
Concurrent use of systemic steroids or chronic use of immunosuppressant medications should be stopped 28-days prior to enrollment. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\< 7.5 mg/day, or equivalent doses of other corticosteroids) is allowed
Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped 28-days prior to enrollment
Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation therapy
With exception to Hydrea which must be stopped prior to initiation of lymphodepletion
Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal prophylaxis are eligible
Not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis
Subjects with \>= Grade 2 myelofibrosis on bone marrow biopsy
Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening if the patient is undergoing leukapheresis. Patients with controlled atrial arrythmia is allowed
Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
History of stroke or intracranial hemorrhage within 6 months prior to screening
Subjects with presence of other active malignancy, however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
Clinically significant uncontrolled illness
Active infection requiring antibiotics
Research participants who have tested human immunodeficiency virus (HIV) positive, or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment
Active viral hepatitis
Females only: Pregnant or breastfeeding
Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Participants who achieve measurable residual disease (MRD)Up to 15 years post study treatment
Defined as complete response (CR) or MRD- complete response with incomplete hematopoietic recovery. Rates and associated 90% Clopper and Pearson binomial confidence limits.
- Incidence of dose-limiting toxicities and full toxicity profileUp to 1 year following the last CAR T cell infusion
Rates and associated 90% toxicity and adverse events will be assessed using Common Terminology Criteria for Adverse Events version 5.0, and modified Cytokine Release Syndrome grading as applicable. Clopper and Pearson binomial confidence limits.