NCT06596057

Safety and Efficacy of CD19 CAR-T/CAR-NK Cells

Head of Hematology，Vice President and Secretary-General of Shandong Stem Cell Society

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Second Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate the safety and efficacy of CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia.

Detailed description

Patients who met the exclusion criteria were treated with advanced FC regimen, and subjects who met the infusion criteria assessed by the investigators were given CAR-T/CAR-NK cell infusion 1 to 2 days after completion of eluvial chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion. The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment. For lymphoma, refer to the 2014 version of Lugano efficacy evaluation criteria

Conditions

• Safety and Efficacy

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T/CAR-NK cells	One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion

Timeline

• Start date: 2024-02-10
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China