Study of Anti-FLT3 CAR-T Cells for Relapsed/Refractory AML
This study is testing a new treatment called Anti-FLT3 CAR-T cells for people with acute myeloid leukemia (AML) that has come back or hasn't responded to other treatments (relapsed/refractory AML). The Anti-FLT3 CAR-T cells are given through an IV after you receive standard chemotherapy. The main goal is to see how safe this treatment is. We're also looking at how well it works to treat AML and how long people live without their disease getting worse. We plan to enroll up to 18 adults and potentially 18 teenagers (ages 12-17) who weigh at least 35 kg. You must be 18 or older to enroll, or 12-17 if safety has been established in adults.
- Study design
- This is a Phase 1 study, meaning it's an early-stage trial focused on safety. It aims to enroll up to 18 adult and 18 pediatric participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured from the time of Anti-FLT3 CAR-T cell infusion until Day 28.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06786533
Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML
Recruiting
PHASE1Ages 12+InterventionalTreatmentHemogenyx Pharmaceuticals LLC
~18 participants
Updated 2025-08-14 on ClinicalTrials.gov
What's tested:Anti-FLT3 CAR-T cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the safety of HG-CT-1 cells based on the proportion of subjects infused with HG-CT-1 who experience a DLT.
Measured over From the time of HG-CT-1 infusion until Day 28
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
18 years of age or older at enrollment. Patients ≥12 and \<18 12 to 17 years of age weighing ≥ 35 kg at enrollment may be included once safety evaluation at the corresponding adult dose escalation protocol have been completed.
Subjects with AML unlikely to be cured with currently available therapies. Specifically, the following groups are eligible:
FLT3 expression must be detectable in AML blast by flow cytometric analysis.
Subjects must have a suitable stem cell transplant donor. Donor may be matched or mismatched and must be found to be suitable according to the institution's standard criteria. That donor shall be "cleared" for donation by institutional standards prior to administration of HG-CT-1. Adult donors can be either related or unrelated, HLA-matched or partially matched. Matched or partially matched umbilical cord blood donors are also eligible.
Subjects with relapsed disease after prior allogeneic transplant must be off systemic immunosuppression for at least 1 month at the time of enrollment without GvHD that requires systemic immunosuppression.
Satisfactory organ functions:
Patients ≥18 must have an ECOG Performance status 0-1. Patients \<18 must have a Lansky/Karnofsky score of ≥50.
Written informed consent is given in patients ≥ 18. In patients \<18 or not developmentally appropriate for consent, written consent will be provided to the parent or legal guardian. Patients ≥12 and \<18 years of age will be additionally provided with assent documentation.
Subjects of reproductive potential must agree to use acceptable birth control methods (as described in protocol Section 4.7).
Exclusion
Pregnant or lactating (nursing) women.
Active second malignancy will not be eligible with the following exceptions:
Subjects with a history of a prior allogeneic stem cell transplantation are excluded if:
Active hepatitis B (HBV) or active hepatitis C (HCV) or any HIV infection. Note: prior HCV that has been appropriately treated or evidence of past HBV infection do not constitute exclusions.
Concurrent use of systemic steroids at a prednisone dose of greater than 10 mg, hydrocortisone greater than 10-12.5 mg/m2/day, or equivalent. Recent, or current use of inhaled steroids is not exclusionary.
Concurrent use of immunosuppressant medications such as calcineurin inhibitors, methotrexate, or alemtuzumab.
Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the site Pl would pose an unacceptable risk to the subject.
Active or uncontrolled viral, bacterial, or fungal infection. May be receiving ongoing therapy for controlled infection.
Subjects with signs or symptoms indicative of active CNS involvement. A CNS evaluation shall be performed as clinically appropriate to rule out CNS involvement. Subjects with adequately treated CNS leukemia are eligible. History of CNS involvement is not exclusionary if CNS has been cleared with a documented negative lumbar puncture and negative imaging (imaging required only if previously showing evidence of CNS leukemia not otherwise documented by spinal fluid assessment).
Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Hyperleukocytosis (\>50,000 blasts/µL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
Patients with Acute Promyelocytic Leukemia are not eligible.
What this trial measures
- Determine the safety of HG-CT-1 cells based on the proportion of subjects infused with HG-CT-1 who experience a DLT.From the time of HG-CT-1 infusion until Day 28
Occurrence of dose-limiting toxicities related to HG-CT-1. First-in-human study with unknown safety of infusion of HG-CT-1.