CART-19 Cells for R/R B-cell Lymphoma

Phase 2

• Conditions: Relapsed or Refractory B-cell Lymphoma

• Registration Number: NCT03391726
• Lead Sponsor: Fujian Medical University

Brief Summary

Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-30
• Study First Submitted QC: 2017-12-30
• Last Update Submitted: 2017-12-30
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Signed written informed consent
• Aged between 1-65 years
• Patients with relapse/refractory B-cell lymphoma
• Cardiac: Left ventricular ejection fraction ≥ 50%
• Adequate renal and hepatic function
• Performance status: Karnofsky ≥ 70%

Exclusion Criteria

• Pregnant or lactating females.
• Any co-morbidity precluding the administration of CART-19 cells.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Disease-free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse events that are related to treatment	1 year

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China