NHL
Conditions
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.
Interventions
DRUGIM19 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
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) at 90 days | 90 days | The primary endpoint was ORR 90 days after IM19 infusion |
Countries
China
Contacts
Primary ContactFei Wu, MD
Outcome results
None listed