Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)

Last updated: May 10, 2021
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Acute Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT04884984
UnicarTherapy2021001
  • Ages 6-65
  • All Genders

Study Summary

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CLL1 positive relapsed/refractory acute myeloid leukemia
  • Age 6-65 years
  • Left ventricular ejection fractions ≥ 0.5 by echocardiography
  • Creatinine < 1.6 mg/dL
  • Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal
  • Total bilirubin <2.0 mg/dL
  • Karnofsky performance status ≥ 60
  • Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion

Exclusion Criteria:

  • Patients are pregnant or lactating
  • Uncontrolled active infection
  • Class III/IV cardiovascular disability according to the New York Heart AssociationClassification
  • Active hepatitis B or hepatitis C infection
  • Patients with HIV infection
  • Patients with history of seizure
  • Active central nervous system leukemia

Study Design

Total Participants: 20
Study Start date:
July 01, 2017
Estimated Completion Date:
December 31, 2024

Study Description

The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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