search
Back to results

Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas

Primary Purpose

Glioma, Malignant Glioma of Brain, Recurrence Tumor

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
chimeric antigen receptor T cells
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Voluntary informed consent for entry of trial;
  • Age greater than 18 years, and less than 70 years;
  • Pathologically confirmed recurrent malignant gliomas;
  • Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study;
  • If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis.
  • Patients must have a Karnofsky performance status of greater than or equal to 70.
  • Life expectancy greater than 3 months;

  • Participants with adequate organ function as measured by:

    1. White blood count greater than or equal to 2500/mm^3; platelets greater than or equal to 100,000/mm^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support
    2. Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL
    3. Serum creatinine less than or equal to 1.5 x upper limit of normal
    4. Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis.

Exclusion Criteria:

  • Female subjects of reproductive potential who are pregnant or lactating;
  • Previous treatment with any gene therapy products or other form immunotherapy;
  • Uncontrolled active infection.
  • Active or latent chronic hepatitis B [detectable hepatitis B surface antigen (HBsAg)] or active hepatitis C (positive serology [hepatitis C virus Ab]) infection.
  • HIV infection;
  • History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40);
  • Currently enrolled in other clinical trials;

Sites / Locations

  • Xuanwu HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological: Chimeric antigen receptor T cells

Arm Description

Outcomes

Primary Outcome Measures

Adverse events attributed to the administration of the chimeric antigen receptor T cells
Determine the toxicity profile of the chimeric antigen receptor T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Secondary Outcome Measures

Objective Response Rate
The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
clinical activity of chimeric antigen receptor T cells
the number of infused chimeric antigen receptor T cells;

Full Information

First Posted
January 22, 2018
Last Updated
June 12, 2021
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Mario Biotech Company, Hebei Senlang BIotech Company, Beijing HuiNengAn Biotech Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03423992
Brief Title
Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas
Official Title
A Pilot Study to Evaluate the Safety and Efficacy of Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas Based on the Expression of Tumor Specific/Associated Antigens
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Mario Biotech Company, Hebei Senlang BIotech Company, Beijing HuiNengAn Biotech Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot study to determine the safety and efficacy of chimeric antigen receptor T cell (autologous T cells transduced with a lentiviral vector expressing chimeric antigen receptor with or without anti-PDL1 antibody) personalized immunotherapy for patients with recurrent malignant gliomas based on the expression of tumor specific/associated antigens (EGFRVIII, IL13Rα2, Her-2, EphA2, CD133, GD2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Malignant Glioma of Brain, Recurrence Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biological: Chimeric antigen receptor T cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
chimeric antigen receptor T cells
Intervention Description
chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively
Primary Outcome Measure Information:
Title
Adverse events attributed to the administration of the chimeric antigen receptor T cells
Description
Determine the toxicity profile of the chimeric antigen receptor T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
Time Frame
1 year
Title
clinical activity of chimeric antigen receptor T cells
Description
the number of infused chimeric antigen receptor T cells;
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary informed consent for entry of trial; Age greater than 18 years, and less than 70 years; Pathologically confirmed recurrent malignant gliomas; Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study; If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis. Patients must have a Karnofsky performance status of greater than or equal to 70. Life expectancy greater than 3 months; Participants with adequate organ function as measured by: White blood count greater than or equal to 2500/mm^3; platelets greater than or equal to 100,000/mm^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL Serum creatinine less than or equal to 1.5 x upper limit of normal Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis. Exclusion Criteria: Female subjects of reproductive potential who are pregnant or lactating; Previous treatment with any gene therapy products or other form immunotherapy; Uncontrolled active infection. Active or latent chronic hepatitis B [detectable hepatitis B surface antigen (HBsAg)] or active hepatitis C (positive serology [hepatitis C virus Ab]) infection. HIV infection; History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40); Currently enrolled in other clinical trials;
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
ZIP/Postal Code
100054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Cheng, M.D.
Phone
8610-83192683
Email
chengye@xwhosp.org
First Name & Middle Initial & Last Name & Degree
Qingtang Lin, M.D., Ph.D.
Phone
8610-83192683
Email
linqingtang@xwhosp.org
First Name & Middle Initial & Last Name & Degree
Qingtang Lin, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Feng Ling, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Ye Cheng, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
34235085
Citation
Lin Q, Ba T, Ho J, Chen D, Cheng Y, Wang L, Xu G, Xu L, Zhou Y, Wei Y, Li J, Ling F. First-in-Human Trial of EphA2-Redirected CAR T-Cells in Patients With Recurrent Glioblastoma: A Preliminary Report of Three Cases at the Starting Dose. Front Oncol. 2021 Jun 21;11:694941. doi: 10.3389/fonc.2021.694941. eCollection 2021.
Results Reference
derived

Learn more about this trial

Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas

We'll reach out to this number within 24 hrs