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CAR T-cell Therapy
Engineered NK Cells for Recurrent Glioblastoma
Phase 1
Recruiting
Led By Shiao-Pei S Weathers
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until the time of first disease progression or relapse (as defined by rano criteria), or death due to disease, assessed up to 6 months post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is to find out the benefits and side effects of using engineered natural killer cells to treat patients with recurrent glioblastoma.
Who is the study for?
Adults with recurrent glioblastoma who've had prior radiation and temozolomide therapy can join this trial. They must have a stable health status, including normal organ function and blood counts, not be pregnant or breastfeeding, agree to use contraception, and understand the study's requirements. Excluded are those with severe allergies to monoclonal antibodies, certain infections or immunodeficiencies, recent immunosuppressive therapy, other active cancers requiring treatment, bleeding disorders or full-dose anticoagulation.
What is being tested?
The trial is testing genetically engineered NK cells designed to fight cancer by deleting TGF-betaR2 and NR3C1 in patients with recurrent glioblastoma. It aims to determine the optimal dose of these modified cells while monitoring for any potential benefits or side effects.
What are the potential side effects?
Potential side effects may include immune reactions due to genetic modifications of the NK cells which could lead to inflammation in various organs. As it's an early-phase trial focusing on dosage safety, specific side effect profiles will be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment until the time of first disease progression or relapse (as defined by rano criteria), or death due to disease, assessed up to 6 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment until the time of first disease progression or relapse (as defined by rano criteria), or death due to disease, assessed up to 6 months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose-limiting toxicities (DLTs) (Group 1)
Secondary study objectives
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
+1 moreSide effects data
From 2016 Phase 2 trial • 60 Patients • NCT0009622693%
Fatigue
81%
Dyspnea
72%
Cough
67%
Hemoglobin
65%
Leukopenia NOS
61%
Nausea
60%
Anorexia
60%
Hyperglycemia NOS
58%
Dysphagia
56%
Esophagitis NOS
53%
Dermatitis radiation NOS
49%
Peripheral sensory neuropathy
46%
Weight decreased
44%
Constipation
44%
Alopecia
39%
Neutrophil count
35%
Pneumonitis NOS
33%
Chest pain
32%
Skin hyperpigmentation
30%
Platelet count decreased
30%
Chest wall pain
28%
Hypoalbuminemia
26%
Hyponatremia
25%
Lymphopenia
25%
Diarrhea NOS
25%
Pleural effusion
23%
Dyspepsia
23%
Vomiting NOS
21%
Aspartate aminotransferase increased
21%
Arthralgia
21%
Insomnia
19%
Sinus tachycardia
19%
Pain - Other
19%
Alanine aminotransferase increased
19%
Dehydration
19%
Hypocalcemia
19%
Myalgia
18%
Esophageal pain
18%
Pericardial effusion
18%
Supraventricular arrhythmia NOS
18%
Pyrexia
18%
Hypokalemia
18%
Atelectasis
18%
Pneumothorax NOS
16%
Blood alkaline phosphatase increased
16%
Hyperkalemia
16%
Dysgeusia
14%
Hypomagnesemia
14%
Back pain
14%
Headache
14%
Dizziness
14%
Pharyngolaryngeal pain
14%
Pruritus
12%
Blood/bone marrow - Other
12%
Pulmonary fibrosis
12%
Dry skin
12%
Sweating increased
12%
Hypersensitivity NOS
11%
Radiation recall syndrome
11%
Metabolic/laboratory - Other
11%
Pain in extremity
11%
Depression
11%
Hypoxia
11%
Laryngitis NOS
11%
Dermatitis exfoliative NOS
11%
Hypotension NOS
9%
Dry mouth
9%
Stomatitis
9%
Blood bilirubin increased
9%
Blood creatinine increased
9%
Anxiety
9%
Thrombosis
9%
Pulmonary/upper respiratory - Other
9%
Dermatology/skin - Other
7%
Edema: limb
7%
Hypermagnesemia
7%
Bone pain
7%
Pollakiuria
7%
Bronchospasm
7%
Hot flushes NOS
7%
Rigors
5%
Gastritis NOS
5%
Vision blurred
5%
Mucositis/stomatitis (functional/symptomatic): Esophagus
5%
Blood bicarbonate decreased
5%
Hypercalcemia
5%
Hypophosphatemia
5%
Muscle weakness NOS
5%
Peripheral motor neuropathy
5%
Ataxia
5%
Confusional state
5%
Epistaxis
5%
Rhinitis allergic NOS
5%
Prolonged chest tube drainage or air leak after pulmonary resection
2%
Arrhythmia NOS
2%
Myocardial ischemia
2%
Abdominal distention
2%
Colonic obstruction
2%
Ocular/visual - Other
2%
Ileus paralytic
2%
Serum sickness
2%
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
2%
Anal infection NOS
2%
Gingival infection
2%
Urinary retention
2%
Acute respiratory distress syndrome
2%
Erythema multiforme
2%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation, Surgery, Chemotherapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2 (CB-NK-TGF-betaR2-/NR3C1-, resection)Experimental Treatment2 Interventions
Patients receive CB-NK-TGF-betaR2-/NR3C1- intratumorally over 5-10 minutes on days 0, 7, and 14. Patients undergo standard of care surgical resection on day 15. Beginning 2 weeks after surgery, patients receive CB-NK-TGF-betaR2-/NR3C1- intratumorally over 5-10 minutes weekly for up to 5 doses (total of 8 doses) in the absence of disease progression or unacceptable toxicity.
Group II: Group 1 (CB-NK-TGF-betaR2-/NR3C1- )Experimental Treatment1 Intervention
Patients receive CB-NK-TGF-betaR2-/NR3C1- intratumorally over 5-10 minutes weekly for up to 8 doses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2023
Completed Phase 2
~420
Cord Blood-derived Expanded Allogeneic Natural Killer Cells
2017
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,240 Total Patients Enrolled
1 Trials studying Supratentorial Glioblastoma
144 Patients Enrolled for Supratentorial Glioblastoma
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,440 Total Patients Enrolled
6 Trials studying Supratentorial Glioblastoma
881 Patients Enrolled for Supratentorial Glioblastoma
Shiao-Pei S WeathersPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood counts meet the required levels for treatment.I have been treated with Gliadel wafers before.I have had cancer treatment directly into the tumor or nearby area.I have a lung condition not caused by an infection.I had radiation therapy less than 3 months ago, unless my cancer showed early progression.I agree to use two effective birth control methods during and for 3 months after the study.I have an immune system disorder or have taken drugs that weaken my immune system in the last week.My cancer is primarily in my brainstem, spinal cord, or has spread outside the brain.I have received treatment with drugs that target immune checkpoints.My tumor is larger than 5 cm.I am 18 years or older.I have HIV, HTLV1/2, active Hepatitis B or C, but not just from a vaccine.I have not received a live vaccine in the last 30 days.I have a bleeding or clotting disorder.I am on a full dose of blood thinners or medication to prevent blood clots.I haven't had chemotherapy or targeted therapy in the last 2 weeks, or I have mild neuropathy.It's been 12 weeks since my last radiation, or my cancer has grown despite treatment.My neurosurgeon believes my tumor can be removed with surgery.My liver tests are within normal limits.I have a tumor larger than 1cm2 that can be surgically removed.I am mostly able to care for myself and carry out normal activities.I have another cancer besides the one being studied, but it's either not growing or doesn't need treatment right now, except for certain skin cancers or cervical cancer that's been treated.I do not have an active infection needing strong medication that could affect my trial participation.My brain cancer has multiple distinct tumors that need separate treatment areas.I haven't needed strong medicine for an autoimmune disease in the last 3 months.I have had an organ transplant that requires me to take medicine to suppress my immune system.I had a brain MRI within the last 30 days.I had surgery over 3 weeks ago or a biopsy over a week ago and have recovered.I have a specific type of brain tumor that has come back after treatment.I am a woman who can have children and have a recent negative pregnancy test.I am using two birth control methods or am not having sex to join this study.My kidney function is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (CB-NK-TGF-betaR2-/NR3C1- )
- Group 2: Group 2 (CB-NK-TGF-betaR2-/NR3C1-, resection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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