RecruitingPhase 1NCT04991870

Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM

A Phase I Clinical Trial With a Window-of-Opportunity Component of Engineered NK Cells Containing Deleted TGF-ßR2 and NR3C1 in Recurrent Grade 4 Astrocytoma (Glioblastoma)


Sponsor

M.D. Anderson Cancer Center

Enrollment

25 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This phase I study tests a new experimental cell therapy made from umbilical cord-derived natural killer (NK) cells that have been engineered to better resist the tumor's defenses. It is designed for patients 12 and older with recurrent high-grade brain cancer (glioblastoma) that has come back after previous treatment. **You may be eligible if...** - You are 12 years or older with confirmed recurrent high-grade glioblastoma or related brain tumor - You have previously received radiation and temozolomide chemotherapy - Your general performance status (Karnofsky/Lansky score) is above 70 - Your blood counts, liver, and kidney function are adequate - You are at least 12 weeks out from radiation (unless your cancer progressed early) - You are willing to use contraception during and for 3 months after treatment **You may NOT be eligible if...** - You previously received bevacizumab (Avastin) or Gliadel wafers - You have a known immunodeficiency or are on immunosuppressive medications - You have active HIV, hepatitis B, or hepatitis C - You have had a prior organ or stem cell transplant - You are pregnant or breastfeeding - Your tumor is in the brainstem or spine, or larger than 5 cm - You have active autoimmune disease requiring systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCord Blood-derived Expanded Allogeneic Natural Killer Cells

Given CB-NK-TGF-betaR2-/NR3C1- intratumorally

PROCEDUREResection

Undergo surgical resection


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04991870


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