Spots Global Cancer Trial Database for Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma
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Trial Identification
Brief Title: Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma
Official Title: Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma
Study ID: NCT06047197
Interventions
Study Description
Brief Summary: This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma
Detailed Description: This trial is a Phase I clinical trial, which is divided into two trial stages. The first stage is a dose-increasing trial stage The second stage is the dose extension experiment stage. The main endpoint is to evaluate its tolerance and safety. The first dose group used rapid titration method for dose increase, and the subsequent dose groups used the classic 3+3 experimental design for dose increase. A total of 4 dose groups are planned to be set up. The second to fourth dose groups will include 3-6 participants in each group
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hematology Hospital of the Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
Contact Details
Name: lugui Qiu, MD
Affiliation: blood diseases hospital，chinese academy of medical sciences
Role: PRINCIPAL_INVESTIGATOR
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