Actively Recruiting
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
Led by Beijing Immunochina Medical Science & Technology Co., Ltd. · Updated on 2020-12-08
52
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
Sponsors
B
Beijing Immunochina Medical Science & Technology Co., Ltd.
Lead Sponsor
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with relapsed or refractory invasive non-Hodgkin's lymphoma confirmed by CD19 positive cytology or histology
- CD20 positive patients must have received corresponding targeted therapy
- Must have measurable disease evidence according to Lugano 2014 standards
- Expected survival of more than 3 months
- ECOG performance status of 0 or 1
- Women of childbearing age must have a negative pregnancy test before starting and agree to effective contraception during the trial
- Voluntary participation with signed informed consent
You will not qualify if you...
- Patients with gastrointestinal lymph nodes and/or central nervous system involvement at risk for CAR-T treatment
- Patients with graft-versus-host disease requiring immunosuppressants or with autoimmune diseases
- Chemotherapy or radiotherapy within 3 days before blood collection
- Use of systemic steroids within 5 days before blood collection (except inhaled steroids)
- Use of drugs stimulating bone marrow hematopoietic cells within 5 days before blood collection
- Previous gene therapy
- History of epilepsy or other central nervous system diseases
- Active Hepatitis B or C infections
- Other tumors within the past 5 years
- Active or uncontrolled infection requiring systemic treatment within 14 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
F
Fei Wu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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