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

ConditionNHL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Immunochina Medical Science & Technology Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • IM19 CAR-T Cells

Treatment groups

52 Participants
are divided into 1 treatment group

Sponsors and collaborators

Beijing Immunochina Medical Science & Technology Co., Ltd.

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborator