Actively Recruiting
Phase I/II Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Adults with Recurrent or Refractory CD19-Positive Aggressive Non-Hodgkin's Lymphoma
Led by Beijing Immunochina Medical Science & Technology Co., Ltd. · Updated on 2020-12-08
52
Participants Needed
1
Research Sites
678 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
Researchers are evaluating the safety and effectiveness of IM19 CAR-T cell therapy in adults with relapsed or refractory CD19-positive non-Hodgkin's lymphoma. This phase I/II study includes a phase I single-center portion focusing on safety and a phase II multi-center portion assessing treatment efficacy for this aggressive lymphoma type. Participants receive IM19 CAR-T cells administered at two different dose levels. Before the cell infusion, all patients undergo treatment with fludarabine and cyclophosphamide for three days to prepare the body. The study is designed to monitor responses and safety throughout treatment. During the trial, researchers will assess the objective response rate at 90 days as the primary outcome. Participants will be monitored for safety and treatment effects, with evaluations based on established lymphoma response criteria. The study aims to enroll adults aged 18 and older and includes informed consent and follow-up measures to track progress and side effects.
CONDITIONS
Brief 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 aged 18 years or older
- Diagnosed with relapsed or refractory invasive non-Hodgkin's lymphoma confirmed to be CD19 positive
- CD20 positive patients have received appropriate targeted therapy
- Must have measurable disease based on Lugano 2014 criteria
- Expected survival time greater than 3 months
- ECOG performance status of 0 or 1
- Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during the study until the last follow-up
- Voluntary participation with signed informed consent
You will not qualify if you...
- Involvement of gastrointestinal lymph nodes or central nervous system posing risk for CAR-T treatment
- History of graft-versus-host disease requiring immunosuppressant treatment or autoimmune disease
- 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 hematopoiesis within 5 days before blood collection
- Previous use of gene therapy products
- History of epilepsy or other central nervous system disorders
- Active Hepatitis B or C virus infection
- Other tumors diagnosed 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive pre-treatment with fludarabine and cyclophosphamide for 3 days before CAR-T cell infusion.
Daily visits for 3 days (in-person)
Duration - Up to 90 days
Participants receive IM19 CAR-T cell therapy to treat relapsed or refractory CD19-positive non-Hodgkin's lymphoma.
1 infusion visit and multiple follow-up visits to monitor response and safety
Duration - Up to 3 years
Participants are monitored for safety and efficacy outcomes after treatment ends.
Periodic visits depending on study schedule
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
F
Fei Wu, MD
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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