CTX-009 with or without CTX-471 for Recurrent Glioblastoma
This study is looking at two drugs, CTX-009 and CTX-471, for people with recurrent glioblastoma (a type of brain cancer that has come back). Researchers want to see if CTX-009 alone, or in combination with CTX-471, is safe and effective. CTX-009 works by targeting ways tumors resist other treatments, and CTX-471 helps boost the body's immune response against the cancer. You might be able to join if you are 18 or older, have recurrent glioblastoma that has been confirmed by a biopsy or scan, and have had standard treatments. The study aims to enroll 54 participants. The main goals are to understand the safety of the treatments and find the right dose for future studies.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a Phase 1B/2 study and plans to enroll 54 participants.
- What's involved
- You would receive CTX-009 and/or CTX-471 intravenously (through a vein) every two weeks in a 28-day cycle. These treatments are given on an outpatient basis.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the start of treatment through 60 days after treatment, which is estimated to be 14 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07392957
Safety and Efficacy of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~54 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:CTX-009CTX-471
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase IB Arm 1: Toxicity as measured by number of participants with adverse events
Measured over Start of treatment through 60 days after treatment (estimated to be 14 months)
+4 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Tanner M Johanns, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically or radiographically confirmed recurrent CNS WHO grade 4 IDH wild-type glioma following standard of care treatment including radiation, chemotherapy, and/or tumor-treating fields. No more than 2 recurrences are allowed.
Patients may receive palliative treatment for recurrent disease prior to study enrollment with surgery or laser thermal ablation but must wait at least 4 weeks post-procedure to start study drug(s) and must have recovered from all procedure-related complications.
At least 18 years of age.
KPS performance status ≥ 60%
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.0 K/cumm
Platelets ≥ 75 K/cumm
Hemoglobin ≥ 8.0 g/dL
Total bilirubin ≤ 1.5 x IULN, unless suspected or documented history of Gilbert's Syndrome, in which case ≤ 2.5 x IULN
AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
Creatinine clearance \> 30 mL/min by Cockcroft-Gault
Urine Protein : Creatinine ratio (UPCR) \< 300 mg/g
QTcF \< 480 msec; in the setting of bundle branch block or other arrhythmia that makes QTcF unreliable, a JT interval \< 350 msec can be used as a substitute.
The effects of CTX-009 and CTX-471 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
Resolution, or stable control with medical management, of all prior anti-cancer therapy toxicities to ≤ grade 1 per NCI-CTCAE v5.0. If the patient has had major surgery, 4 weeks must have elapsed from the date of surgery and the first dose of study drug(s).
Stable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to start of study drug(s). For Arm 2: a maximum of 2 mg daily dose of dexamethasone or equivalent at time of study drug(s) initiation is allowed.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion
Have progressed on prior anti-VEGF-A therapy (i.e., bevacizumab) or developed clinically significant adverse reaction to any anti-VEGF therapy (i.e., bevacizumab, regorafenib) which led to discontinuation of treatment. Prior treatment with low dose anti-VEGF therapy for management of symptomatic vasogenic edema or radiation necrosis is permitted as long as progression was not noted while receiving treatment with the anti-VEGF agent, and is not needed for continued control of symptoms. A 4-week washout from last dose of low-dose anti-VEGF therapy is required.
Prior systemic anti-cancer therapy including: investigational agents or immunotherapy within 4 weeks (can consider 2 week interval for agents with known 5 half-lives \<14 days following discussion with study PI); chemotherapy within 4 weeks (6 weeks for BCNU or CCNU); or targeted therapy within 2 weeks prior to treatment.
Use of aspirin, NSAIDs, or other antiplatelet agents within 7 days of study drug(s) initiation. Regular use (i.e., daily) of these agents should be avoided while on study treatment.
Use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes within 7 days of study drug(s) initiation. Prophylactic dosing of DOAC, such as apixaban or edoxaban, or LMWH for patency of venous access devices is allowed (preference is given to DOAC over LMWH).
History of intraparenchymal or subdural hemorrhage. History of hemorrhage-related or gastroenterological disease including active hemorrhage, hemorrhagic diathesis, coagulopathy, or tumor in great arteries. History of clinically significant gastroenterological disease, such as peptic ulcer, GI bleeding, GI or non-GI fistula, perforation, abdominal abscess, percutaneous drains, clinical symptoms and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease (IBD).
History of unprovoked high-risk thromboembolic events.
A history of the following cardiovascular diseases in the past 5 years (a case-by-case evaluation can be considered in consultation with the study PI):
Congestive heart failure that corresponds to Class II or a higher class under NYHA classification or \< 50% of LVEF
Uncontrolled hypertension (140/90 mmHg despite best care including anti-hypertensive medications). White coat hypertension is not exclusionary.
Hypertensive crisis or pre-existing hypertensive encephalopathy
Pulmonary hypertension
Myocardial infarction
Uncontrolled arrhythmia
Unstable angina
Significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to study entry
For Arm 2: Prior treatment with other investigational immune-oncology therapies targeting CD137 (4-1BB).
For Arm 2: Systemic therapy with non-steroidal immunosuppressive agents within 7 days prior to first dose. Patients with a prior history of autoimmune disease not requiring immunosuppressive therapy may be eligible following discussion with the study PI. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed.
Prior solid organ or hematologic cell transplantation.
For Arm 2: Has received a live or live-attenuated vaccine within 30 days prior to the first dose. Note: administration of killed vaccines is allowed.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CTX-009 or CTX-471.
Active uncontrolled seizure disorder.
Active uncontrolled intercurrent illness including, but not limited to: infection, hypertension, open wound(s), or cardiac arrhythmia. Chronic illnesses controlled (i.e., clinically asymptomatic) with oral medications are allowed.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose for Arm 1 or 72 hours of first dose for Arm 2.
HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
What this trial measures
- Phase IB Arm 1: Toxicity as measured by number of participants with adverse eventsStart of treatment through 60 days after treatment (estimated to be 14 months)
Adverse events will be graded according to CTCAE v6.0
- Phase IB Arm 1: Recommended Phase 2 Dose (RP2D)Start of treatment through completion of cycle 1 (each cycle is 28 days)
RP2D will be determined from the phase IB portion of Arm 1 by assessing tolerability. Tolerability is defined as ≤1 among patients experiencing excessive dose limiting toxicities (DLTs). The dose level in phase IB determined to be tolerable is the RP2D.
- Phase IB Arm 2: Toxicity as measured by number of participants with adverse eventsStart of treatment through 60 days after treatment (estimated to be 14 months)
Adverse events will be graded according to CTCAE v6.0
- Phase II Arm 1: Overall survival rate at 12 months (OS12)12 months
Overall survival is defined from time of treatment start to time of death due to any cause or latest follow-up, whichever is earlier, with an inference focus on 12-month overall survival.
- Phase II Arm 2: Overall survival rate at 12 months (OS12)12 months
Overall survival is defined from time of treatment start to time of death due to any cause or latest follow-up, whichever is earlier, with an inference focus on 12-month overall survival.