A Study of Universal CD19-Targeted UCAR-NK Cells Combined With HSCT for B Cell Hematologic Malignancies

Launched by 920TH HOSPITAL OF JOINT LOGISTICS SUPPORT FORCE OF PEOPLE'S LIBERATION ARMY OF CHINA · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients with certain types of B-cell blood cancers, specifically B-cell lymphoblastic leukemia and lymphoma. The study is testing a therapy that uses special immune cells, called UCAR-NK cells, that are designed to target cancer cells marked by a specific protein (CD19). This treatment will be combined with a procedure known as hematopoietic stem cell transplantation (HSCT), which helps restore healthy blood cells after cancer treatment. The goal is to see how effective and safe this combination therapy is for treating these cancers.

To be eligible for this trial, participants must be 75 years old or younger and have a confirmed diagnosis of a B-cell tumor that expresses the CD19 protein. Additionally, they should be in generally good health and have a life expectancy of at least 12 weeks. Participants will need to undergo certain tests and follow study procedures, but they will receive close monitoring throughout the trial. It's important to note that individuals with certain health conditions or recent treatments may not be able to participate. This trial is currently recruiting participants, and those interested should discuss it with their healthcare team to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with indications for hematopoietic stem cell transplantation;
• • 2. Age ≤75 years old;
• • 3. Confirmed B-cell tumor and tumor cells expressing CD19；
• • 4. Expected survival time \>12 weeks;
• • 5. Eastern cooperative oncology group (ECOG) score is 0-2;
• • 6. Adequate liver , kidney and cardiopulmonary function;
• • 7. Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
• Exclusion Criteria:
• • 1. Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening;
• • 2. At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening;
• • 3. Patients who had undergone hematopoietic stem cell transplantation (ASCT), allogeneic hematopoietic stem cell transplantation (HSCT), or solid organ transplantation within 12 weeks before screening; Grade 2 or higher graft versus host disease(GVHD) requiring immunosuppressive therapy occurred within 2 weeks before screening;
• • 4. Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;
• • 5. Have received live attenuated vaccine within 6 weeks before rinsing;
• • 6. Had a cerebrovascular accident or seizure within 6 months before screening;
• • 7. History of deep venous thrombosis or pulmonary embolism within 6 months before screening;
• • 8. A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening;
• • 9. Previous history of Alzheimer's disease;
• • 10. Autoimmune diseases leading to end-organ damage or requiring systemic immunosuppression (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus) within 2 years prior to screening;
• • 11. There are uncontrollable infections;
• • 12. Women who are pregnant or breastfeeding; Or women of childbearing age who have positive pregnancy tests during the screening period; Male or female patients who did not wish to use contraception from the time of signing the informed consent to 1 year after receiving the NK cell infusion;
• • 13. Conditions that other researchers deemed inappropriate for participating in the study.

Trial Officials