NCT04601181

Safety and Efficacy of ThisCART22 in Patients With Refractory or Relapsed B Cell Malignancies

A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD22 in Patients With Refractory or Relapsed B Cell Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fundamenta Therapeutics, Ltd. · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, nonrandomized, open-label, study to evaluate the safety and clinical activity of allogeneic CAR-T targeting CD22 in patients with refractory or relapsed CD22-positive B cell malignancies

Detailed description

The patients will receive infusion of ThisCART22 cells from health donor ,to evaluate the safety and efficacy of ThisCART22 Cells in patients with refractory or relapsed CD22-positive B cell malignancies. In this study, the dose range is 0.2-60 x10\^6 cells per kg body weight (no more than 3.0 x 10\^9 in total).

Conditions

• B Cell Malignancy

Interventions

Type	Name	Description
BIOLOGICAL	ThisCART22 cells injection	Assigned Interventions Biological/Vaccine: ThisCART22 cells 0.2-60 x 10\^6 CAR-T cells per kg body weight. Intervention study

Timeline

• Start date: 2020-10-23
• Primary completion: 2022-10-15
• Completion: 2023-10-15
• First posted: 2020-10-23
• Last updated: 2020-12-01

Locations

1 site across 1 country: China