Phase
Condition
Astrocytoma
Gliomas
Treatment
Autologous genetically modified gamma-delta T cells
Allogeneic genetically modified gamma-delta T cells
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with histologically or cytologically confirmed history of IDH-wild typeglioblastoma
Phase 1b and Arm B of Phase 2: Subjects must have completed no more than onestandard therapy for glioblastoma, have received no prior Avastin® therapy (unless solely used for edema management) and be eligible for resection
Arms A and C: Subjects must have newly diagnosed, treatment naïve glioblastoma
Phase 1b and Arm B and Arm C: Subjects must have a partially matchedhaploidentical or matched related donor.
Subjects with magnetic resonance imaging (MRI) features consistent with andsuspicious for recurrent malignant glioma in Phase 1b and Arm B.
Agreeable to inserting and maintaining a Rickham catheter.
≥ 18 years of age.
Karnofsky Performance Status ≥ 70%
Female subjects of childbearing potential must have a negative urine/serum pregnancytest within 72 hours of study enrollment. Female subjects of childbearing potentialare those who have not been surgically sterilized or have not been free of mensesfor > 2 years.
Male subjects and their female partners and female subjects of childbearingpotential must be willing to use a combination of two methods of birth control or besurgically sterile or abstain from heterosexual activity for the course of thestudy.
Exclusion
Exclusion Criteria:
Subject in Arm A or donor from Phase 1b, Arms B, and Arm C received vaccinationswithin 4 weeks or underwent surgery (major or minor) within 72 hours beforeleukapheresis collection.
Cellular immunotherapy or gene therapy or within six weeks prior to entering thestudy, surgical resection or alkylating agent chemotherapy within four weeks priorto entering the study, receiving tumor treating fields (TTF) Optune therapy, or havereceived experimental immunotherapy at any time
Subjects receiving any other investigational agents concurrently while on study.
Have not recovered from adverse events (≤ Grade 1) from previously administeredtherapy. Subjects with alopecia unless of immune origin are an exception to thiscriterion and may qualify for this study
Have received prior treatment with an allogeneic therapy, including bone marrow orsolid tumor transplant.
Concurrent malignancy or an active second malignancy. Subjects with a history ofsecond malignancy must have no evidence of cancer for two years prior to enrolmentor have a surgically cured cancer with low risk of recurrence to enroll. Discusswith medical monitor prior to enrolment.
Contraindication to the placement of an intracranial access device (Rickhamcatheter) at the time of surgery.
Prior history of encephalitis, multiple sclerosis, or other CNS infection <1 yearprior to glioblastoma diagnosis.
Uncontrolled intercurrent illness including, but not limited to ongoing or activeinfection, or any other medical condition that precludes surgery. Also,medical/surgical/psychiatric illness/social situations that would limit compliancewith study requirements or confound interpretation of safety and efficacy data.Subjects with a history of seizure as a result of their glioblastoma must be seizurefree and on appropriate anti-epileptic medication for 3 weeks prior to dosing withthe investigational agent.
Allergies/hypersensitivity to amino bisphosphonates such as Zoledronate®,Pamidronate® or similar.
History of HIV or active hepatitis even if well controlled or history of anautoimmune condition.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
UC San Diego Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
UCLA
Los Angeles, California 90024
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, Kentucky 40202
United StatesSite Not Available
MHealth Clinics and Surgery Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University Wexner Medical Center- James Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
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