Human CD19 Targeted T Cells Injection Therapy for Relapsed and Refractory CD19-positive Leukemia (NCT03798509) | Clinical Trial Compass
UnknownPhase 1
Human CD19 Targeted T Cells Injection Therapy for Relapsed and Refractory CD19-positive Leukemia
China18 participantsStarted 2019-03-13
Plain-language summary
To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 18 to 70 Years Old, Male and female;
✓. Expected survival \> 12 weeks;
✓. ECOG score 0-1;
✓. Bone marrow examination clearly diagnosed as CD19 positive B-cell acute lymphoblastic leukemia and who met one of the following conditions:
✓. Those who failed to achieve CR after at least 2 courses of standard chemotherapy or had early relapse after complete remission (\<12 months) or late relapse after complete remission (≥ 12 months) and failed to achieve CR after 1 course of standard chemotherapy;
✓. For Ph+ ALL: in addition to receiving at least 2 courses of standard chemotherapy, at least two TKIs should be treated with no complete remission or relapse after complete remission (Patients who cannot tolerate TKI therapy or have TKI treatment contraindications or have T315i mutation are excluded);
✓. Those who relapse after stem cell transplantation are not affected by previous treatments;
✓. The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
Exclusion criteria
✕. Graft-versus-host disease (GVHD), or need to use immunosuppressants;
✕. Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
✕. Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
✕. Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
✕. Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
✕. Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
✕. Received CAR-T treatment or other gene therapies before enrollment;
✕. Patients with symptoms of central nervous system;