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Recruiting NCT05755828

Clinical Study of Autologous Stem Cell Transplantation + Anti-CD19 CAR T Cells for B-cell Lymphoma

Conditions: B-cell Lymphoma

Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE2
Enrollment: 30
Sponsor: The Affiliated Hospital of Xuzhou Medical University

Location: China

Summary

To evaluate the CR rate of B-NHL subjects who achieved PR at intermediate assessment after first-line chemotherapy treated with autologous stem cell transplantation + Anti-CD19 CAR T cells.

Eligibility Criteria

Inclusion Criteria:Patients or their legal guardians voluntarily participate and sign the informed consent;Male or female patients aged 18-70 years (including 18 and 70 years);CD19+ B-NH was confirmed by pathology and histology, and the patient achieved a partial response (PR) by interim assessment after 3-4 courses of first-line chemotherapy;B-cell non-Hodgkin lymphoma mainly includes the following two types:(1) Diffuse large B-cell lymphoma (DLBCL); Mantle cell lymphoma (MCL); 5. Measurable or evaluable lesions; 6. The patient's main tissues and organs function well:Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;Renal function: creatinine < 220μmol/L;Lung function: indoor oxygen saturation ≥95%;Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 7. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 8. Patients with ECOG score ≤2 and expected survival time ≥3 months.Exclusion Criteria:Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding;Men or women who have planned to become pregnant within the last 1 year;The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment;Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;Active hepatitis B/C virus;Hiv-infected patients;Suffering from a serious autoimmune disease or immunodeficiency disease;The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;The patient had participated in other clinical trials within 6 weeks prior to enrollment;Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);Suffers from mental illness;The patient has substance abuse/addiction;According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05755828). StuddyBuddy aggregates publicly available trial information.