Actively Recruiting
Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML
Led by Hemogenyx Pharmaceuticals LLC · Updated on 2025-08-14
18
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
H
Hemogenyx Pharmaceuticals LLC
Lead Sponsor
M
M.D. Anderson Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 1 dose escalation study to determine the safety of anti-FLT3 CAR-T in subjects with R/R AML. The primary objective is to assess safety. Up to 18 evaluable adult and 18 evaluable pediatric subjects will be enrolled. Evaluable subjects are defined as those who have received an infusion of HG-CT-1. Primary clinical objectives: i. Determine the safety of HG-CT-1 based on the proportion of subjects infused with HG-CT-1 who experience a dose limiting toxicity (DLT). Secondary clinical objectives: i. Estimate the efficacy of HG-CT-1 according to standard clinical response criteria for AML. ii. Estimate overall survival of evaluable subjects. iii. Estimate progression-free survival of evaluable subjects. iv. Estimate duration of response in evaluable subjects who achieve a response. Secondary scientific objectives: i. Describe the persistence and trafficking of HG-CT-1. ii. Describe HG-CT-1 bioactivity and its predictors.
CONDITIONS
Official Title
Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at enrollment
- Patients aged 12 to 17 years weighing at least 35 kg may be included after adult safety evaluation
- Subjects with AML unlikely to be cured with current therapies, including refractory AML or relapsed AML after stem cell transplant or initial treatment
- Detectable FLT3 expression on AML blasts by flow cytometry
- Suitable stem cell transplant donor found and cleared by institutional standards
- Subjects with relapsed disease after prior allogeneic transplant must be off systemic immunosuppression for at least 1 month without graft-versus-host disease requiring treatment
- Satisfactory organ functions including kidney, liver, heart, and lung function
- Performance status: ECOG 0-1 for adults, Lansky/Karnofsky score of at least 50 for those under 18
- Written informed consent obtained; assent documentation for patients aged 12 to under 18
- Agreement to use acceptable birth control methods if of reproductive potential
You will not qualify if you...
- Pregnant or lactating (nursing) women
- Active second malignancy except certain controlled or indolent cancers
- Less than 100 days post prior allogeneic stem cell transplant
- Ongoing active graft-versus-host disease requiring immunosuppression or recent donor lymphocyte infusion
- Active hepatitis B, hepatitis C, or any HIV infection
- Concurrent use of high-dose systemic steroids or immunosuppressant medications
- Uncontrolled symptomatic illnesses including infection, heart failure, arrhythmia, psychiatric illness, or social situations limiting study compliance
- Active or uncontrolled infections, though controlled infections under treatment are allowed
- Signs or symptoms of active central nervous system involvement unless adequately treated and cleared
- Known allergy or hypersensitivity to study product components
- Hyperleukocytosis with greater than 50,000 blasts per microliter or rapidly progressive disease
- Diagnosis of Acute Promyelocytic Leukemia
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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