Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma

Last updated: February 9, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Not Recruiting

Phase

1

Condition

Gliomas

Astrocytoma

Treatment

B7-H3-targeting CAR-T cells

Clinical Study ID

NCT05241392
TX103T-IG005
  • Ages 18-75
  • All Genders

Study Summary

This is an open, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability and preliminary effectiveness of B7-H3-targeting Chimeric Antigen Receptor-T (CAR-T) cell therapy on patients with recurrent glioblastomas. The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, aged 18-75 years (including 18 and 75 years old);

  2. Patients with relapsed glioblastoma, as confirmed by positron emission tomography (PET) or histologic pathology;

  3. A >= 30% staining extent of B7-H3 in his/her primary/recurrent tumor tissue by theimmunochemical method;

  4. Karnofsky scale score>=50

  5. Availability in collecting peripheral blood mononuclear cells (PBMCs) ;

  6. Adequate laboratory values and adequate organ function;

  7. Patients with childbearing/fathering potential must agree to use highly effectivecontraception;

Exclusion

Exclusion Criteria:

  1. Pregnant or breastfeeding females;

  2. Contraindication to bevacizumab;

  3. Within 5 days before the CAR-T cell infusion, subjects receiving systemicadministration of steroids with dosage more than 10mg/d prednisone or the equivalentdoses of other steroids ( not including inhaled corticosteroid);

  4. Comorbid with Other uncontrolled malignancy;

  5. Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus ortuberculosis infection;

  6. Subjects receiving the placement of a carmustine slow-release wafer within 6 monthsbefore the enrollment;

  7. Autoimmune diseases;

  8. Receiving long-term immunosuppressive treatment after organ transplantation;

  9. Severe or uncontrolled psychiatric diseases or condition that could increase adverseevents or interfere the evaluation of outcomes;

  10. Not recovered from the toxicities or side effects by previous treatment;

  11. Subjects who have participated the other interventional trial within one monthbefore the enrollment, or have received other CAR-T cell therapies or gene-modifiedcell therapy before enrollment.

  12. Subjects with medical conditions that affect signing the written informed consent orcomplying with the research procedures, the medical conditions including, but notlimited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonaryembolism, coagulation disorders, active systemic infection, uncontrolled infectionet. al; or patients who are unwilling or unable to comply with the researchprocedures; these

  13. Subjects with other conditions that would interfere trial participation at theinvestigator's discretion.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: B7-H3-targeting CAR-T cells
Phase: 1
Study Start date:
January 27, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

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