Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID06762132

A Clinical Study to Evaluate Safety and Effects of CD33 CAR-T Cell Therapy for Relapsed or Refractory Acute Myeloid Leukemia

Led by Zhejiang University · Updated on 2025-01-07

27

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

Sponsors

Z

Zhejiang University

Lead Sponsor

Y

Yake Biotechnology Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CD33 CAR-T Cell therapy in treating patients with relapsed or refractory acute myeloid leukemia (AML). This early phase 1, single-arm, open-label, dose-escalation trial plans to enroll 15 to 27 participants who have limited treatment options and meet specific diagnostic criteria for AML with high CD33 expression. The study aims to explore how well this targeted cellular therapy works and monitor its safety in this patient population. Participants will receive CD33 CAR T-cells through intravenous infusion. The study involves escalating doses to determine the appropriate treatment level. The trial does not include a comparison group and focuses on one treatment approach. The therapy preparation involves generating CAR-T cells from patients, with some patients eligible if autologous CAR-T cells cannot be prepared. Treatment is carefully administered and monitored within the study setting. During the study, participants will be closely observed for dose-limiting toxicities up to 28 days after treatment and for any treatment-emergent adverse events for up to two years. Assessments include clinical evaluations, laboratory tests, heart function tests, oxygen levels, and monitoring of AML disease status. Safety and effectiveness data will guide the understanding of this therapy's potential. The study requires informed consent and involves follow-up visits to ensure participant safety and treatment monitoring over an extended period.

CONDITIONS

Official Title

A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, age 18 years or older
  • Able to prepare CAR-T cells normally or have failed autologous CAR-T cell preparation
  • Diagnosed with CD33 positive acute myeloid leukemia with CD33 expression rate above 80%
  • Meet the 2016 WHO classification for AML and criteria for relapsed or refractory AML according to Chinese guidelines
  • Bone marrow primitive cells (promyelocytes and/or myelocytes) greater than 5% morphologically or greater than 1% by flow cytometry
  • Total bilirubin less than or equal to 51 micromol/L, ALT and AST less than or equal to 3 times the upper normal limit, serum creatinine less than or equal to 176.8 micromol/L
  • Left ventricular ejection fraction (LVEF) at least 50% by echocardiography
  • No active lung infection with oxygen saturation above 92% on room air
  • Estimated survival time more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Pregnant or lactating women, or patients with fertility willing to use effective contraception for at least 6 months after last infusion
  • Voluntarily agree to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • History of epilepsy or other central nervous system diseases
  • Prolonged QT interval or severe heart disease
  • Untreated active infection
  • Active hepatitis B or C infection
  • Previous use of gene therapy products
  • Proliferation rate less than 5 times response to CD3/CD28 co-stimulation
  • Other uncontrolled diseases deemed unsuitable by researchers
  • HIV infection
  • Any condition increasing risk or interfering with study results as judged by researchers

AI-Screening

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Trial Site Locations

Total: 1 location

1

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

H

He Huang, MD

Y

Yongxian Hu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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