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

Early Phase 1

Active, not recruiting

• Conditions: Safety and Efficacy
• Interventions: Biological: CAR-T/CAR-NK cells

• Registration Number: NCT06596057
• Lead Sponsor: The Second Hospital of Shandong University

Brief 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

Study Timeline

• Study Start: 2024-02-10
• Study First Submitted: 2024-08-13
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	CAR-T/CAR-NK cells	-

Primary Outcome Measures

Name	Time	Method
ORR	At least half a year	With reference to iRecist1.1, the proportion of patients whose tumor volume shrank to the pre-specified value and maintained the minimum time limit.The time from randomization to tumor progression or death from any cause.
PFS	one year	In tumor therapy, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain time. It includes the number of patients with complete response (CR) and partial response (PR) as a proportion of the total number of evaluable cases

Trial Locations

Locations (1)

Shandong Province; 🇨🇳 Shandong, Shandong, China