Clinical trial NCT04440436: Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: NHL
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Simcere Pharmaceutical Co., Ltd.
First posted: 2020-06-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate(ORR) at 90 days
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Yuqin Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: