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

NCT07579208 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-0884NCI-2026-03536
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chimera Antigen Receptor (CAR); Recurrent Glioblastoma; Phase 1; NK Cell; IL13Ra; EGFRvIII; NR3C1

Outcome Measures

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

  Through study completion; an average of 1 year

Study Arms (3)

Arm 1 Intra-tumoral

EXPERIMENTAL

Will receive the NK cells as an intra-tumoral administration

Drug: NK Cells

Arm 2 Intra-Ventricular

EXPERIMENTAL

Will receive the NK cells as an intra-arterial administration

Drug: NK Cells

Arm 3 Intra-arterial

EXPERIMENTAL

Will receive the NK cells as an intra-arterial administration .

Drug: NK Cells

Interventions

NK Cells DRUG

Given by Ommaya Reservoir

Arm 1 Intra-tumoral; Arm 2 Intra-Ventricular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy (such as tacrolimus, cyclosporine, infliximab) within 7 days prior to study registration.
• Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent such as thrombocytopenia or platelets toxicity. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study at the discretion of the treating investigator.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include superficial tumors considered adequately treated locally with curative intent, including but not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Any exceptions must be discussed with the protocol PI.
• Has known Gliomatous meningitis or extracranial disease, or tumor localized primarily to the brainstem or spinal cord
• Midline shift greater than 0.5 cm or pending herniation
• Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants receiving epidural steroid injections for pain will be excluded. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis
• Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the subject's participation, assessment of experimental treatment toxicity or increase the subject's risk of side effects
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Chibawany Ene, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chibawanye Ene, MD

CONTACT

713-792-2400; cene@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): October 24, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1)