Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IM19 CAR-T cells IM19 CAR-T cells be administrated in two dose level |
Drug: IM19 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Objective Response Rate(ORR) at 90 days [90 days]
The primary endpoint was ORR 90 days after IM19 infusion
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.
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CD20 positive patients undergo corresponding targeted therapy.
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Patients must have evaluable evidence of disease (according to Lugano 2014 standards).
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≥ 18 years old.
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The expected survival period is more than 3 months.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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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
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Participate voluntarily in this experiment and sign the informed consent.
Exclusion Criteria:
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The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.
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Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease
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Subject has used chemotherapy or radiotherapy within three days before the blood collection period.
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Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).
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Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection
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Subject has used any gene therapy products before.
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Subject with a history of epilepsy or other central nervous system diseases.
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Active Hepatitis B Virus or Hepatitis C Virus infections
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The subject with other tumors in the past 5 years.
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Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Beijing Cancer Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Yuqin Song, MD, PhD, Peking University Cancer Hospital & Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SD45