Trials Sponsors Conditions Drugs Pricing

Conditions

Langerhans Cell Histiocytosis

Keywords

CAR-T cell therapyLangerhans Cell histiocytosisCD207

Outcome Measures

Primary Outcomes (2)

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.
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)
2 years

Secondary Outcomes (4)

Progression Free Survival (PFS) of CD207 CAR-T cell therapy in patients with r/r langerhans cell histiocytosis
2 years
Overall Survival (OS) of CD207 CAR-T cell therapy in patients with r/r langerhans cell histiocytosis
2 years
Effects of CD207 CAR-T cells on human immune system
2 years
Metabolism of CAR T-cells in vivo
2 years

Study Arms (1)

CD207 CAR-T cells

EXPERIMENTAL

Cohort 1 will receive 1 x 10\^6 CAR+ T cells/kg. Cohort 2 will receive 3 x 10\^6 CAR+ T cells/kg. Cohort 3 will receive 5 x 10\^6 CAR+ T cells/kg. Cohort 4 will receive 1 x 10\^7 CAR+ T cells/kg.

Biological: CD207 CAR-T cells

Interventions

CD207 CAR-T cellsBiological

Single dose of CD207 CAR-T cells administered IV

CD207 CAR-T cells

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age3 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Relapsed or refractory langerhans cell histiocytosis, defined as: 1) any relapse during standard chemotherapy; 2) not responding to standard chemotherapy; 3) not achieving CR after first cycle of second-line chemotherapy for relapsed langerhans cell histiocytosis;
years old;

Sponsors & Collaborators

Beijing Friendship Hospital
Otherlead
Beijing Boren Hospital
Othercollaborator

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

Zhao Wang, PhDCONTACT86-63139862 wangzhao@ccmu.edu.cn

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

ZHAO Wang, MD
Beijing Friendship Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHAO Wang, MD

CONTACT

86-63139862 wangzhao@ccmu.edu.cn

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of hematology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 28, 2022

Study Start

October 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 1, 2025

Safety and Efficacy of CD207 Targeted CAR-T Cell Therapy in Patients With R/R Langerhans Cell Histiocytosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

CD207 CAR-T cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

CD207 CAR-T cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations