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

STATUS

Recruiting
End date

Jun 4, 2035
participants needed

52
sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

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Updated on 19 February 2024

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targeted therapy

lymphoma

hodgkin's disease

non-hodgkin lymphoma

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 /. 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 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.

Details

Condition	follicular lymphoma, follicular lymphoma, Lymphoma
Age	18-100 years
Treatment	IM19 CAR-T Cells
Clinical Study Identifier	NCT04440436
Sponsor	Beijing Immunochina Medical Science & Technology Co., Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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)
	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

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