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NCT06786533 · ClinicalTrials.gov registry record · Phase 1
Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML
A Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML), sponsored by Hemogenyx Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06786533 is a Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) that is actively recruiting participants, run by Hemogenyx Pharmaceuticals. The registered enrollment target is 18 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06786533, a Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML), is actively recruiting participants, sponsored by Hemogenyx Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Anti-FLT3 CAR-T cells
Study Locations (1)
Texas
- MD Anderson - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-01-23 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06786533
The ClinicalTrials.gov registry entry for NCT06786533 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hemogenyx Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) appearing as the primary indexed condition, and to 1 intervention - of which Anti-FLT3 CAR-T cells is the first listed.
NCT06786533 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06786533 about?
NCT06786533 is a clinical study titled "Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML". 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...
What is the current status of trial NCT06786533?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-01-23. Estimated completion is 2027-01.
What conditions does trial NCT06786533 study?
This clinical trial studies the following conditions: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML).
What interventions are being tested in trial NCT06786533?
The interventions under investigation include: Anti-FLT3 CAR-T cells (DRUG).
Who is sponsoring clinical trial NCT06786533?
This trial is sponsored by Hemogenyx Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06786533 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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