Phase 1Phase 1NCT07579208
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
A Phase 1 study testing NK Cells in people with Phase 1 and NK Cell, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find the best method of administering NK cells in patients with recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- NK Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2026to 30 Jul 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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
- Has received a live vaccine within 30 days prior to the first dose of trial treatment
- Has a contraindication for undergoing MRIs
- Has evidence of bleeding diathesis or coagulopathy
- Is on full dose anticoagulants or antiplatelet therapy that cannot be held (full dose depends on the actual anticoagulant)
- Has significant hemorrhage on baseline scan defined as >1 cm diameter of acute blood
- Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant)
- Has multifocal disease. Subject has multifocal GBM, defined as discrete sites of contrast enhancing disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Chibawany Ene, MD, 713-792-2400, cene@mdanderson.org
Chibawanye Ene, MD
About this study
To find the best method of administering NK cells in patients with recurrent glioblastoma.
Read the detailed description
Primary Objectives
- To undertake a window of opportunity (WOO) clinical trial to compare the biological endpoints of Dual CAR Dual KO NK cells persistence, immunological phenotype and anti-tumor function after administration of Dual CAR Dual KO NK cells via 3 different routes: intra-tumoral, intra-ventricular or intra-arterial injection. By quantitatively assessing post-treatment specimens, the trial will determine the optimal route of administration of this agent.
- To assess the safety of Dual CAR Dual KO NK cells after administration via 3 different routes: intra-tumoral, intra-ventricular or intra-arterial injection.
Secondary Objectives
- To determine response as measured by Response Assessment in Neuro-Oncology (RANO), progression free survival (PFS), time to progression (TTP), and overall survival (OS).
- To assess for systemic changes in immune cell subpopulations in the peripheral blood, serum analysis of immune correlates, CSF NK cell persistence/immune correlates, alloreactivity characterization, anti-HLA antibody analysis.
- Being tested
- NK Cells
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK CellsDrug
Given by Ommaya Reservoir
NK CellsDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Intra-tumoral | Experimental | Will receive the NK cells as an intra-tumoral administration Receives: Drug: NK Cells |
| Arm 2 Intra-Ventricular | Experimental | Will receive the NK cells as an intra-arterial administration Receives: Drug: NK Cells |
| Arm 3 Intra-arterial | Experimental | Will receive the NK cells as an intra-arterial administration . Receives: Drug: NK Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start21 Aug 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chibawany Ene, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579208
- Sponsor's protocol ID
- 2025-0884
- Other IDs
- NCI-2026-03536
- Status last verified
- Aug 2026
- First submitted
- 6 May 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07579208
- Acronym / sponsor ID
- 2025-0884
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find the best method of administering NK cells in patients with recurrent glioblastoma.
Detailed description
Primary Objectives
- To undertake a window of opportunity (WOO) clinical trial to compare the biological endpoints of Dual CAR Dual KO NK cells persistence, immunological phenotype and anti-tumor function after administration of Dual CAR Dual KO NK cells via 3 different routes: intra-tumoral, intra-ventricular or intra-arterial injection. By quantitatively assessing post-treatment specimens, the trial will determine the optimal route of administration of this agent.
- To assess the safety of Dual CAR Dual KO NK cells after administration via 3 different routes: intra-tumoral, intra-ventricular or intra-arterial injection.
Secondary Objectives
- To determine response as measured by Response Assessment in Neuro-Oncology (RANO), progression free survival (PFS), time to progression (TTP), and overall survival (OS).
- To assess for systemic changes in immune cell subpopulations in the peripheral blood, serum analysis of immune correlates, CSF NK cell persistence/immune correlates, alloreactivity characterization, anti-HLA antibody analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Intra-tumoral | Experimental | Drug: NK CellsWill receive the NK cells as an intra-tumoral administration |
| Arm 2 Intra-Ventricular | Experimental | Drug: NK CellsWill receive the NK cells as an intra-arterial administration |
| Arm 3 Intra-arterial | Experimental | Drug: NK CellsWill receive the NK cells as an intra-arterial administration . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK CellsGiven by Ommaya Reservoir | Drug | Arm 1 Intra-tumoral, Arm 2 Intra-Ventricular |
| NK CellsGiven by IV | Drug | Arm 3 Intra-arterial |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chibawany Ene, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NK Cells in people with Phase 1 and NK Cell, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chibawanye Ene, MD (713-792-2400, cene@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.