Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma

Who is this study for? Adult patients with Non-Hodgkin's lymphomas
What treatments are being studied? IM19 CAR-T Cells
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Fei Wu, MD
wufei@immunochina.com
+8615801390058
Time Frame
Start Date: 2020-06-04
Estimated Completion Date: 2035-06-04
Participants
Target number of participants: 52
Treatments
Experimental: IM19 CAR-T cells
IM19 CAR-T cells be administrated in two dose level
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu Simcere Pharmaceutical Co., Ltd.
Leads: Beijing Immunochina Medical Science & Technology Co., Ltd.

This content was sourced from clinicaltrials.gov