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

NCT05341947 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: IIT2019-23-Rudnick-ATC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

glioma; brain tumor; glioblastoma; neurosurgery; surgical resection; Complete resection of tumor; extent of resection; maximal safe resection; neuropathology; astrocytoma; ependymoma

Outcome Measures

Primary Outcomes (1)

• Number of Grade 3 or higher toxicities, number of serious adverse events, and the number of treatment-related toxicities to find the maximum tolerated dose

  Recorded and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5

  From start of study treatment until End of Study, an average of 2 months

Secondary Outcomes (6)

• Overall Survival (OS)

  From date of enrollment to date of death of any cause or withdrawal of consent, whichever came first. Assessed up to 3 years.

• Progression-Free Survival (PFS)

  From start of study treatment, until confirmation of disease progression or withdrawal of consent, whichever came first. Assessed up to 3 years.

• Health-related quality of life parameters

  From baseline visit to End of Study, an average of 2 months

• Overall Response Rate (ORR)

  From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years.

• Immune Response

  At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2

Study Arms (1)

Activated T cells

EXPERIMENTAL

Biological: Activated T cells

Interventions

Activated T cells BIOLOGICAL

Activated T cells (ATC) administered intravenously at one timepoint

Activated T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeremy Rudnick, M.D: lead
• Kairos Pharma: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Glioblastoma; Glioma; Brain Neoplasms; Astrocytoma; Ependymoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jeremy Rudnick, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director, Neuro-Oncology

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 22, 2022
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-09

Locations

US (1)