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 statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • NK Cells

    Drug

    Given by Ommaya Reservoir

  • NK Cells

    Drug

    Given by IV

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Arm 1 Intra-tumoralExperimental treatment 1 intervention
Group B: Arm 2 Intra-VentricularExperimental treatment 1 intervention
Group C: Arm 3 Intra-arterialExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and adverse events (AEs).

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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