Status:
RECRUITING
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
Lead Sponsor:
Beijing Immunochina Medical Science & Technology Co., Ltd.
Collaborating Sponsors:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
NHL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 no...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 4 2035
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04440436
Start Date
June 4 2020
End Date
June 4 2035
Last Update
December 8 2020
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China