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

NCT05477446 | Unknown Phase 1

• 1 other identifier: BRYY-IIT-LCYJ-2022-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Langerhans Cell Histiocytosis

Keywords

CAR-T cell therapy; Langerhans Cell histiocytosis; CD207

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 cells BIOLOGICAL

Single dose of CD207 CAR-T cells administered IV

CD207 CAR-T cells

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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;
• Expected survival time ≥ 3 months;
• ECOG performance status of 0 or 1 (age ≥ 16 years) or Karnofsky performance status\> 80 (age \< 16 years) ;
• With single or venous blood collection standards, and no other cell collection contraindications;
• WBC ≥ 2.5×10\^9/L ，LY ≥ 0.7×10\^9/L，LY% ≥15%;
• Serum creatinine ≤ 2.0 mg/dl;
• ALT/AST ≤ 2.5 x ULN;
• Total bilirubin ≤ 2.0 mg/dl;
• PT:INR\<1.7, or PT is within 4s of the normal value;
• Ability and willingness to adhere to the study visit schedule and all protocol requirements.

You may not qualify if:

• Transduced CAR+ T lymphocytes\<5%, or expansion \<5 folds after stimulation with anti CD3/anti CD28 beads;
• Pregnant or breasting-feeding women;
• Active hepatitis B or hepatitis C infection;
• Patients with HIV infection;
• Uncontrolled active infection;
• Use of systemic corticosteroid therapy;
• Have received gene therapy, or any other CAR-T treatment;
• Allergic to immunotherapy and related drugs;
• History of heart disease requiring treatment, or poorly controlled hypertension;
• Preceding and/or ongoing active ulcer or gastrointestinal bleeding;
• Have received allogeneic hematopoietic stem cell transplantation, or eligible for allogeneic hematopoietic stem cell transplantation;
• Severe central nervous system involvement;
• Severe lung involvement;
• Hyponatremia (serum sodium\<125mmol/L);
• Hypokalemia (Serum kalium\<3.5mmol/L);

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing Boren Hospital: collaborator

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

Location

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Histiocytosis; Lymphatic Diseases; Hemic 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
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)