Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorM.D. Anderson Cancer Center
About this trial
This phase I trial is to find out the best dose, possible benefits and/or side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \[CB\]-NK-TGF-betaR2-/NR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-/NR3C1- cells are genetically changed immune cells that may help to control the disease.
Eligibility criteria
Qualifiers
Signed and dated informed consent.
Male or female participants aged ≥ 12 years on the day of signing informed consent.
Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or gliosarcoma and recurrent IDHmutant grade 4 astrocytoma, and recurrent gliosarcoma with any prior number of recurrences, and who have received prior radiation and temozolomide therapy. Participants will be eligible if the original histology was lower-grade glioma grade 2 or 3 and a subsequent histological diagnosis of recurrent glioblastoma or IDH-mutant grade 4 astrocytoma is made.
Karnofsky Performance Score (KPS) of >70 at trial entry. Lansky >70 at trial entry for patients less than 16.
Disqualifiers
Has received prior therapy with Gliadel or bevacizumab.
Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.
Is currently participating in or has participated in a study of cancer directed investigational agent or using an investigational device within 4 weeks since last dose of agent administration or device use, or is planning to continue or start treatment with Optune® during participation in this trial.
Has known severe hypersensitivity to monoclonal antibodies, any history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.
Trial design
Treatments tested in this trial
- Cord Blood-derived Expanded Allogeneic Natural Killer Cells
- Resection
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov