NCT05570188

Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies

An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-CD19 Universal CAR-NK(U-CAR-NK) Cells Therapy Combined With Hematopoietic Stem Cell Transplantation(HSCT) for B Cell Hematologic Malignancies

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kunming Hope of Health Hospital · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 U-CAR-NK Cells Therapy combined with HSCT for B cell hematologic malignancies.

Detailed description

Who can participate? Patients who were diagnosed with B cell hematologic malignancies and tumor cells expressing CD19. How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-CD19 U-CAR-NK cells, which belong to chimeric antigen receptor modified NK cells. The administration time is 1-7 days after hematopoietic stem cell infusion. Patients were then evaluated for long-term efficacy and safety until 2 years after U-CAR-NK cells infusion. What are the possible benefits and risks of participating? Benefits: The Dual effect of anti-tumor and anti-infection of NK cells may be used to promote the engraftment of hematopoietic stem cell and better disease control. Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, thrombocytopenia, thrombotic microangiopathy, and possibly other unknown adverse reactions. Where is the study run? Kunming Hope of Health Hospital.

Conditions

• B-cell Lymphoma
• B-cell Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19 UCAR-NK cells	Enrolled participants are chosen to receive one of three different dose levels of U-CAR-NK cells: Dose level one: 5-10×10\^6/kg; Dose level two:1-2×10\^7/kg; Dose level three:2-5×10\^7/kg.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-31
• Completion: 2025-10-31
• First posted: 2022-10-06
• Last updated: 2022-11-30

Locations

1 site across 1 country: China