NCT04384393

Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundamenta Therapeutics, Ltd. · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.

Detailed description

This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10\^6 cells per kg body weight.

Conditions

• B Cell Malignancy

Interventions

Type	Name	Description
BIOLOGICAL	ThisCART19 cells	0.2-60 x 10\^6 CAR T cells per kg body weight.

Timeline

• Start date: 2020-05-09
• Primary completion: 2022-11-10
• Completion: 2023-10-24
• First posted: 2020-05-12
• Last updated: 2022-01-11

Locations

2 sites across 1 country: China