A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia

Launched by IMMUNE CELL, INC. · Dec 19, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment called CD19 targeted CAR-T therapy for patients with certain types of blood cancers, specifically B Cell Leukemia and B Cell Lymphoma. The goal of this study is to see if these specially designed immune cells can safely target and kill cancer cells that have a marker called CD19. Participants will receive several doses of their own modified T cells, which are a type of immune cell, and researchers will monitor how safe and effective this treatment is.

To be eligible for this trial, patients need to have CD19 positive leukemia or lymphoma that has not responded to previous treatments and must have survived for more than 12 weeks after their last therapy. Other health criteria include having certain levels of lung and heart function and no uncontrolled infections or serious medical conditions. This trial is open to people of all genders and ages, from 18 years onward. Participants can expect regular check-ups and monitoring during the study, and it’s important for them to provide informed consent before joining. This trial is currently recruiting participants, and it represents a hopeful step towards more targeted cancer treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CD19 positive leukemia and lymphoma，relapsed and/or refractory：
• • survival\>12 weeks;
• • FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
• • LVEF≥50%;
• • Creatinine\<2.5mg/dl;
• • Bilirubin\<2.5mg/dl;
• • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal;
• • At least 7 days after last chemotherapy;
• • provide with informed consent.
• Exclusion Criteria:
• • Active clinically significant CNS dysfunction
• • Pregnant or breast-feeding women.
• • Uncontrolled active infection including hepatitis B or C.
• • HIV positive.
• • Use of systemic steroids within 72 hours.
• • Allogeneic lymphocyte treatments within recent 6 months.
• • Any uncontrolled active medical disorder.