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Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBeijing Immunochina Medical Science & Technology โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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). * โ‰ฅ 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.
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What it tests

  • IM19 CAR-T Cells
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Where

1 site
Beijing Cancer Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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