To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors

Launched by HEBEI SENLANG BIOTECHNOLOGY INC., LTD. · May 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach using a special type of immune cells called dual-target chimeric antigen receptor (CAR) T cells for patients with certain types of B cell blood cancers that have not responded to previous treatments. Specifically, it focuses on patients with refractory or relapsed B cell tumors, such as various types of leukemia and lymphoma. The goal of the trial is to observe how well this treatment works and how safe it is over a period of at least two years.

To be eligible for the trial, participants must be between 18 and 70 years old, have a specific type of B cell tumor that hasn’t improved with other therapies, and have certain health conditions that are stable. They also need to have detectable proteins called CD19, CD20, or CD22 on their cancer cells. Participants can expect to receive the CAR T cell treatment and will be monitored closely for their response and any side effects. It’s important to know that individuals with certain other health conditions or infections may not be able to participate in the study. If you or a loved one is considering taking part in this trial, it’s a great opportunity to contribute to research that could help improve treatment options for blood cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);
• • 2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;
• • 4.Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.
• Exclusion Criteria:
• • 1. With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;
• • 2. Presence of other malignant tumors;
• • 3. There are severe infections that cannot be effectively controlled;
• • 4. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;
• • 5. Known positive serology for human immunodeficiency virus (HIV) or syphilis;
• • 6. A history of severe allergies to biological products (including antibiotics);
• • 7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);
• • 8. Female patients who are under pregnancy and/or lactation;
• • 9. Active autoimmune disease requiring systemic immunosuppressive therapy;
• • 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.