A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia

  • STATUS
    Recruiting
  • End date
    Jul 19, 2026
  • participants needed
    34
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 19 June 2022

Summary

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell acute lymphocytic leukemia

Description

This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of LCAR-AIO in patients ≥ 18 years of age with relapsed or refractory B-cell acute lymphocytic leukemia. Patients who meet the eligibility criteria will receive a single dose of LCAR-AIO infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.

Details
Condition Acute Lymphocytic Leukemia
Treatment LCAR-AIO Cells
Clinical Study IdentifierNCT05292898
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent
Age 18-75 years
ECOG score: 0-1
Detect the expression of at least one of CD19/CD20/CD22 in leukemic cells by Flow cytometry in peripheral blood or bone marrow
Leukemia cells in the bone marrow >5%
Pathologically confirmed relapsed/refractory ALL must meet one of the following
conditions
Naive patients who failed to achieve CR1 after standard chemotherapy
relapse within 12 months after CR1, or relapse after 12 months but fail to achieve CR2
twice or more bone marrow relapse
Philadelphia chromosomal positive (Ph+) and unable to tolerate TKI therapy, failed TKI therapy more than 2 lines, or had contraindications for TKI therapy
Clinical laboratory values meet screening visit criteria
Expected survival ≥ 3 months

Exclusion Criteria

Prior antitumor therapy with insufficient washout period; 2.CNS infiltration; Except for
patients with prior CNS infiltration who are currently in remission; 3.Have received two or
more targets (CD19/CD20/CD22) CAR-T cell therapy (including but not limited to sequential
infusion) at any previous time, or have received CAR-T cell therapy from Camel family
origin; 4.With acute or chronic graft-versus-host disease; 5.Isolated extramedullary
relapse, but hepatic, spleen, or lymph node-isolated extramedullary relapse is acceptable
HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 7.Pregnant or lactating women
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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