Clinical trial NCT05341947: Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
Official title: A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Recurrent Glioblastoma
Keywords: glioma
brain tumor
glioblastoma
neurosurgery
surgical resection
Complete resection of tumor
extent of resection
maximal safe resection
neuropathology
astrocytoma
ependymoma
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Kairos Pharma
First posted: 2022-04-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: From start of study treatment until End of Study, an average of 2 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of enrollment to date of death of any cause or withdrawal of consent, whichever came first. Assessed up to 3 years.
measure: Progression-Free Survival (PFS)
timeFrame: From start of study treatment, until confirmation of disease progression or withdrawal of consent, whichever came first. Assessed up to 3 years.
measure: Health-related quality of life parameters
timeFrame: From baseline visit to End of Study, an average of 2 months
measure: Overall Response Rate (ORR)
timeFrame: From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years.
measure: Immune Response
timeFrame: At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2
measure: Tumor stem cell antigen expression
timeFrame: At Baseline visit and at time of recurrence. Assessed up to 3 years.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Jeremy Rudnick, MD
role: PRINCIPAL_INVESTIGATOR
References: