Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

Launched by KECELLITICS BIOTECH COMPANY LTD · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a type of blood cancer called B-cell lymphoma, specifically those whose disease has come back or hasn’t responded to previous treatments. The treatment being tested involves using specially modified immune cells, known as CAR-T cells, that target two specific proteins on the cancer cells, CD19 and CD22. The goal is to see if this approach is safe and effective in helping patients combat their lymphoma.

To participate in this trial, patients must be between the ages of 3 and 70 and have already tried at least one standard cancer treatment that didn’t work. They should have specific types of lymphoma that express certain markers (CD19 and/or CD22) on their cancer cells. Participants can expect to receive close monitoring throughout the trial to ensure their safety and track how well the treatment works. It’s important to note that this study is not yet recruiting participants, and there are a few health conditions that could prevent someone from joining, such as serious heart or lung problems, active infections, or recent use of specific medications. If you or a loved one are interested in this trial, it’s a good idea to discuss it with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Relapsed or refractory B cell non-hodgkin lymphoma.
• • 2. KPS\>60.
• • 3. Life expectancy\>12 weeks.
• • 4. Gender unlimited, age from 3 years to 70 years.
• • 5. Evidence for cell membrane CD19 and/or CD22 expression;
• • 6. Patients who have failed at least one line of a standard treatment.
• • 7. No serious mental disorder.
• • 8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
• • 9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
• • 10. No other tumors.
• • 11. Patients volunteer to participate in the research.
• • 12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
• Exclusion Criteria:
• • 1. Pregnancy and nursing females.
• • 2. Patients are allergic to cytokines.
• • 3. Uncontrolled active infection.
• • 4. Acute or chronic GVHD.
• • 5. Treated with T cell inhibitor.
• • 6. Patients who had used steroid hormones within one week.
• • 7. Patients who had used Rituximab within two weeks.
• • 8. HIV/HBV/HCV Infection.
• • 9. Other situations we think improper for the research.