Status:
ACTIVE_NOT_RECRUITING
Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ependymoma
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial investigates the side effects of brain tumor-specific immune cells (IL13Ralpha2-CAR T cells) in treating patients with leptomeningeal disease from glioblastoma, ependymoma, or medul...
Detailed Description
PRIMARY OBJECTIVES: I. Examine and describe the safety and feasibility of IL13Ralpha2-specific hinge-optimized 41BB-co-stimulatory CAR truncated CD19-expressing autologous T-lymphocytes (IL13Ralpha2-...
Eligibility Criteria
Inclusion
- Participant has verified leptomeningeal metastases
- Participant must have a Karnofsky performance status (KPS) \>= 60
- Participant must have a life expectancy of \>= 8 weeks
- If participant has a ventriculoperitoneal shunt, the valve must be programmable, and must be able to tolerate their shunts being turned off for 48 hours
- The effects of IL13Ralpha2-CAR T cells on a developing fetus are unknown. For this reason, women of child-bearing potential must have negative serum pregnancy test and agree to use a reliable form of birth control prior to study entry and for at least two months following study treatment. Male research participants must agree to use a reliable form of birth control and not donate sperm during the study and for at least two months following study treatment
- Participant has a histologically confirmed IL13Ralpha2+ tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score \>= 50)
- Participant must have the ability to understand and the willingness to sign a written informed consent
- No known contraindications to leukapheresis, steroids, or tocilizumab
Exclusion
- Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks
- Research participant requires dialysis
- Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy
- Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase 1 study. A legal guardian may substitute for the research participant
- Participant is unwilling to stop treatment with chemotherapy or endocrine therapy and/or radiation one week prior and during the first 4 cycles of the IL13Ralpha2-CAR T cell study
- Shunted participants either have a non-programmable shunt valve, or cannot tolerate their shunts being turned off for 48 hours
- Participant has a coagulopathy or bleeding disorder or cannot safely discontinue anticoagulation prior to placement of a Rickham reservoir
- Participant has a chronic or active viral infection of the central nervous system (CNS)
- Participant has any uncontrolled illness, including ongoing or active infection; participant has known active hepatitis B or C infection; participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
- Participant is human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of signing the main informed consent
- Participant has an autoimmune disease
- Participant has another active malignancy
- Participant is unable to undergo a brain magnetic resonance imaging (MRI)
- Participant is pregnant or breast feeding. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IL13Ralpha2-CAR T cells, breastfeeding should be discontinued if the mother wants to participate in this study
- Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04661384
Start Date
March 5 2021
End Date
November 17 2025
Last Update
June 3 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010