RecruitingEarly Phase 1NCT06760260

Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia

A Study to Evaluate the Safety and Efficacy of CI-135 CAR-T Cell Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia


Sponsor

Hrain Biotechnology Co., Ltd.

Enrollment

7 participants

Start Date

Jan 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of immune cell therapy called CAR-T cells for people with acute myeloid leukemia (AML) — a blood cancer — that has come back or stopped responding to treatment. The therapy involves engineering a patient's own immune cells to target cancer cells that carry a protein called FLT3. **You may be eligible if...** - You are between 18 and 70 years old - You have AML that has not gone into remission after treatment, or has relapsed - Your cancer cells have a FLT3 mutation or high FLT3 protein expression - Your heart, liver, kidneys, and lungs are functioning adequately - You are in reasonably good health (able to care for yourself) **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific AML subtype called APL/M3) - You have previously received CAR-T cell therapy - You have active hepatitis B, hepatitis C, HIV, or syphilis - You have a history of serious heart problems - You had a blood clot in the past 3 months - You are pregnant, breastfeeding, or planning pregnancy within a year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman Derived anti-CI135 CAR-T Injection

Autologous genetically modified anti-CI135 CAR transduced T cells


Locations(1)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06760260


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