A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia
Acute Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for Acute Lymphocytic Leukemia
Eligibility Criteria
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:
1.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; 6.HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 7.Pregnant or lactating women;
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Sites / Locations
- Beijing Gobroad BoRen HospitalRecruiting
- Institute of Hematology & Blood Diseases HospitalRecruiting
Arms of the Study
Arm 1
Experimental
LCAR-AIO Cells
Each subject will be treated with LCAR-AIO Cells