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IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes for Metastases

City of Hope Medical Center, Duarte, CA
Metastases+4 More ConditionsIL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes - Biological
Eligibility
18+
All Sexes

Study Summary

This trial is testing the effects of brain tumor-specific immune cells on patients with leptomeningeal disease from glioblastoma, ependymoma or medulloblastoma.

Eligible Conditions
  • Leptomeningeal Metastases
  • Glioblastoma
  • Medulloblastoma
  • Ependymoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 15 years

15 years
Biomathematical Modeling of perfusion/diffusion
Biomathematical Modeling of tumor growth
Baseline
CAR T and endogenous cells detected in tumor tissue
IL13Ralpha2 antigen expression levels in tumor tissue
IL13Raphs2 antigen expression levels in tumor tissue.
Up to 15 years
Biomathematical modeling of perfusion/diffusion
Neoplasms
Disease response
Incidence of adverse events
Overall survival
Time to progression
Week 4
CAR T cell detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF)
CAR T cell levels detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF)
Cerebrospinal fluid shunts procedure
Cytokine levels in PB, TCF and CSF
Endogenous T cell levels detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF)

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment (IL13Ralpha2-CAR T cells)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes · No Placebo Group · Phase 1

Treatment (IL13Ralpha2-CAR T cells)
Biological
Experimental Group · 1 Intervention: IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 15 years

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
535 Previous Clinical Trials
2,249,924 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,368 Total Patients Enrolled
Lisa A FeldmanPrincipal InvestigatorCity of Hope Medical Center

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 8 more weeks.
References

Frequently Asked Questions

Are there opportunities currently open to join this research endeavor?

"According to information found on the clinicaltrials.gov website, enrollment for this trial is still open. The study was initially posted in March 5th 2021 and has been amended as ofMarch 9th 2022." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of people participating in this investigation?

"Affirmative. According to the clinicaltrials.gov website, this research initiative is actively seeking participants and was initially published on March 5th 2021; it has since been updated on March 9th 2022. The study requires 30 volunteers to be sourced from a single site." - Anonymous Online Contributor

Unverified Answer

Has the FDA approved IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes for therapeutic use?

"Due to the limited clinical data available, our team has assigned a score of 1 for the safety of IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes in this Phase 1 trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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