A Phase1 Clinical Trial Evaluating Locoregional Delivery Of Engineered NK Cells Containing IL13Ra And EGFvIII Chimeric Antigen Receptor (CAR), IL-21 Secretion And Deleted TGF-BetaR2 And NR3C1 In Recurrent Glioblastoma

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To find the best method of administering NK cells in patients with recurrent glioblastoma.

Eligibility criteria

Qualifiers

Male or female subjects aged ≥ 18 years.

Histologically confirmed supratentorial 2021 World Health Organization recurrent glioblastoma (IDH-wildtype GBM), gliosarcoma, or recurrent IDH-mutant WHO grade 4 astrocytoma, with any prior number of recurrences.

Have received prior radiation and temozolomide therapy.

Single tumor no larger than 5 cm in its greatest diameter.

Disqualifiers

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 an investigational agent or using an investigational device within 4 weeks since last dose of agent administration.

Has known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v5.0), any history of anaphylaxis, within 5 months.

Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1/2 antibodies); HTLV1 and/or HTLV2; active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Participants with prior HBV vaccination (anti-HBs positive, HBsAg negative, anti-HBc negative) will NOT be excluded.

Trial design

Treatments tested in this trial

  • NK Cells
  • NK Cells

Treatment groups

36 Participants
are divided into 3 treatment groups

Locations

1
MD Anderson Cancer Center77030, HoustonTexas, United States

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor