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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    100
  • sponsor
    Xuanwu Hospital, Beijing
Updated on 20 June 2021
growth factor
karnofsky performance status
prothrombin
immunohistochemistry
malignant glioma
erbb2

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, IL13R2, Her-2, EphA2, CD133, GD2).

Details
Condition Glioma, Recurrent Tumor, Malignant Glioma of Brain, Recurrence Tumor, Gliomas, Tumor Recurrence, neoplasm recurrence, glial tumor
Treatment Chimeric antigen receptor T cells
Clinical Study IdentifierNCT03423992
SponsorXuanwu Hospital, Beijing
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

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, IL13R2, 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note