An Interventional Open-label, Single-group, Phase I/II Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Adult Patients With Relapsed or Refractory Forms of B-cell Lymphoproliferative Disorders

Study Summary

This study is testing a new type of treatment called anti-CD19 CAR-T cell therapy for adults with certain blood cancers that have returned or did not respond to previous treatments. CAR-T cells are a type of immune cell that is specially designed in a lab to target and destroy cancer cells with a marker called CD19. The main goals of this study are to find out if this treatment is safe, how well patients tolerate it, and how effective it is at controlling cancer. The study will include 60 adults, ages 18-70, who meet specific criteria for participation. Patients will first receive a short course of chemotherapy to prepare their bodies for the CAR-T cells. The CAR-T cells will then be given in two doses through an IV. Patients will be monitored closely in the hospital for about a month to check for any side effects and see how their cancer responds. The researchers will also follow up with patients over time to learn more about how long the CAR-T cells stay active, how well they fight cancer, and the overall health of the patients after treatment.

Interventions

Study Locations

Facility	City	State	Country
National Medical Research Center for Hematology	Moscow		Russia

Official Trial Information

View on ClinicalTrials.gov