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

Jeremy Rudnick, M.D

Status and phase: Withdrawn; Phase 1

Conditions: Recurrent Glioblastoma

Treatments: Biological: Activated T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05341947

IIT2019-23-Rudnick-ATC

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Activated T cells

Experimental group

Treatment:

Biological: Activated T cells