This is a single-arm study to evaluate the efficacy and safety of CD207 targeted CAR-T cell therapy in relapsed and refractory langerhans cell histiocytosis.
There are limited options for treatment of r/r langerhans cell histiocytosis. CD207 is expressed on the membrane surface of langerhans cells,and it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CD207 targeted CAR- T cell therapy in patients with r/r langerhans cell histiocytosis. The primary goal is safety and efficiency assessment, including incidence and severity of adverse events and overall response rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single dose of CD207 CAR-T cells administered IV
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Overall Response Rate (ORR)
The number of cases with complete response (CR) and partial response (PR) after treatment as a percentage of the total cases.
Time frame: 2 years
Incidence and Severity of Adverse Events (AEs)
Treatment-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: 2 years
Progression Free Survival (PFS) of CD207 CAR-T cell therapy in patients with r/r langerhans cell histiocytosis
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression.
Time frame: 2 years
Overall Survival (OS) of CD207 CAR-T cell therapy in patients with r/r langerhans cell histiocytosis
OS will be assessed from the first CAR-T cell infusion to death from any cause.
Time frame: 2 years
Effects of CD207 CAR-T cells on human immune system
Dynamic changes of T cell subset and immune globulin.
Time frame: 2 years
Metabolism of CAR T-cells in vivo
Absorption, distribution and metabolism of CD207-CAR T cells in vivo.
Time frame: 2 years
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