Phase
Condition
Astrocytoma
Brain Tumor
Brain Cancer
Treatment
IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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, andmust 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 thisreason, women of child-bearing potential must have negative serum pregnancy test andagree to use a reliable form of birth control prior to study entry and for at leasttwo months following study treatment. Male research participants must agree to use areliable form of birth control and not donate sperm during the study and for atleast two months following study treatment
Participant has a histologically confirmed IL13Ralpha2+ tumor expression byimmunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score >= 50)
Participant must have the ability to understand and the willingness to sign awritten informed consent
No known contraindications to leukapheresis, steroids, or tocilizumab
Exclusion
Exclusion Criteria:
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 evidentprogressive encephalopathy
Failure of research participant to understand the basic elements of the protocoland/or the risks/benefits of participating in this phase 1 study. A legal guardianmay substitute for the research participant
Participant is unwilling to stop treatment with chemotherapy or endocrine therapyand/or radiation one week prior and during the first 4 cycles of the IL13Ralpha2-CART cell study
Shunted participants either have a non-programmable shunt valve, or cannot toleratetheir shunts being turned off for 48 hours
Participant has a coagulopathy or bleeding disorder or cannot safely discontinueanticoagulation 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 signsor symptoms of active infection, positive blood cultures or radiological evidence ofinfections
Participant is human immunodeficiency virus (HIV) seropositive based on testingperformed 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 potentialrisk for adverse events in nursing infants secondary to treatment of the mother withIL13Ralpha2-CAR T cells, breastfeeding should be discontinued if the mother wants toparticipate in this study
Prospective participants who, in the opinion of the Investigator, may not be able tocomply with all study procedures (including compliance issues related tofeasibility/logistics)
Study Design
Study Description
Connect with a study center
City of Hope Medical Center
Duarte, California 91010
United StatesSite Not Available
City of Hope Medical Center
Duarte 5344147, California 5332921 91010
United StatesSite Not Available

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