An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders

Launched by NATIONAL RESEARCH CENTER FOR HEMATOLOGY, RUSSIA · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called anti-CD19 CAR-T cell therapy for adults with certain types of blood cancers, specifically Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia (ALL). This follow-up study aims to understand how safe and effective this treatment is over a longer period, especially for patients whose cancer has returned or didn’t respond to other treatments. CAR-T cell therapy works by taking a patient’s own immune cells, modifying them in a lab to specifically target cancer cells, and then putting them back into the patient’s body to help fight the cancer.

To participate in this study, patients must have completed a previous study (HemC101-01-01) and must not be pregnant. They will have regular check-ups over about 11 months to monitor any side effects, see how well the cancer responds to the treatment, and track the CAR-T cells in their body. This study does not involve new treatments; it focuses on gathering important information to improve care for future patients. It's important to note that certain health issues or treatments might prevent someone from joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Successful completion of the HemC101-01-01 study procedures.
• • 2. Negative pregnancy test for women of reproductive potential.
• Exclusion Criteria:
• • 1. Uncontrolled life-threatening infection. A urinary tract infection is acceptable. Patients who received intravenous antibiotics before IMP administration or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study. Prophylactic use of antibiotics, antiviral, or antifungal drugs is allowed.
• • 2. The use of therapeutic interventions prohibited by the protocol (glucocorticosteroids, allogeneic cell therapy, GVHD therapy, chemotherapy, alemtuzumab, clofarabine, cladribine, and biologics derived from mouse materials).
• • 3. Non-adherence to HemC101-01-01 study procedures that, in the investigator's opinion, put the patient at risk if they participate in the study and may significantly bias the assessment of study results.
• • 4. Any clinically relevant data that, in the investigator's opinion, affects the patient's ability to enter the study and puts the patient at risk.