Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma

NCT ID: NCT05341947

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-30
• Study Completion Date: 2027-12-31

Brief Summary

The purpose of this study is to examine the use of activated T cells (ATCs) to assess the safety and tolerability of autologous activated T cells, as measured by the number of Grade 3 or higher toxicities, the number of serious adverse events, and treatment-related toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of overall survival, rate of progression-free survival, health-related quality of life parameters, overall response rate, immune response, and tumor stem cell antigen expression.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Activated T cells

Group Type: EXPERIMENTAL

Activated T cells

Intervention Type: BIOLOGICAL

Activated T cells (ATC) administered intravenously at one timepoint

Interventions

Activated T cells

Activated T cells (ATC) administered intravenously at one timepoint

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Recurrent glioblastoma
• HLA-A1 and HLA-A2 positive
• Complete resection of tumor

Exclusion Criteria

• Clinically significant pulmonary, cardiac or other systemic disease
• Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed.
• Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition.
• Known history of Hepatitis B or Hepatitis C
• Allergy to Dimethyl sulfoxide (DMSO)
• Allergy to gentamicin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kairos Pharma

UNKNOWN

Sponsor Role: collaborator

Jeremy Rudnick, M.D

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Rudnick, M.D

Co-Director, Neuro-Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeremy Rudnick, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2019-23-Rudnick-ATC

Identifier Type: -

Identifier Source: org_study_id