Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

NHL Clinical Trial

Official title:

Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440436
• Other study ID #: SD45
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 4, 2020
• Est. completion date: June 4, 2035

Study information

• Verified date: December 2020
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: Fei Wu, MD
• Phone: +8615801390058
• Email: wufei[@]immunochina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.

Description:

This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 4, 2035
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.

• CD20 positive patients undergo corresponding targeted therapy.

• Patients must have evaluable evidence of disease (according to Lugano 2014 standards).

• = 18 years old.

• The expected survival period is more than 3 months.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up

• Participate voluntarily in this experiment and sign the informed consent.

Exclusion Criteria:

• The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.

• Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease

• Subject has used chemotherapy or radiotherapy within three days before the blood collection period.

• Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).

• Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection

• Subject has used any gene therapy products before.

• Subject with a history of epilepsy or other central nervous system diseases.

• Active Hepatitis B Virus or Hepatitis C Virus infections

• The subject with other tumors in the past 5 years.

• Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• NHL

Intervention

Drug:
• IM19 CAR-T Cells
IM19 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.	Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate(ORR) at 90 days	The primary endpoint was ORR 90 days after IM19 infusion	90 days