GlioblastomaPhase 1NCT03636477
A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102
A Phase 1 study testing Ad-RTS-hIL-12, veledimex and Nivolumab in people with Glioblastoma, run by Alaunos Therapeutics at 4 sites in United States.
Trial summary
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human interleukin-12 (IL-12). IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Ad-RTS-hIL-12, veledimex and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Jun 2018to 30 Jun 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject ≥18 and ≤75 years of age
- Provision of written informed consent for tumor resection, stereotactic surgery, tumor biopsy, samples collection, and treatment with investigational products prior to undergoing any study specific procedures
- Histologically confirmed supratentorial glioblastoma
- Evidence of tumor recurrence/progression by magnetic resonance imaging (MRI) according to response assessment in neuro-oncology (RANO) criteria after standard initial therapy
- Previous standard-of-care antitumor treatment including surgery and/or biopsy and chemoradiation. At the time of registration, subjects must have recovered from the toxic effects of previous treatments as determined by the treating physician. The washout periods from prior therapies are intended as follows: (windows other than what is listed below should be allowed only after consultation with the Medical Monitor)
- Nitrosureas: 6 weeks
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- Other cytotoxic agents: 4 weeks
- Antiangiogenic agents, including bevacizumab: 4weeks
- Targeted agents, including small molecule tyrosine kinase inhibitors: 2 weeks
- Vaccine-based therapy: 3 months
- Able to undergo standard MRI scans with contrast agent before enrollment and after treatment
- Karnofsky Performance Status ≥70%
- Adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements:
- Hemoglobin ≥9 g/L
- Lymphocytes >500/mm3
- Absolute neutrophil count ≥1500/mm3
- Platelets ≥100,000/mm3
- Serum creatinine ≤1.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤5 x ULN
- Total bilirubin < 1.5 x ULN
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal institutional limits
- Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate <5% per year) from the Screening Visit through 28 days after the last dose of study drug. Women of childbearing potential (perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential) must have a negative pregnancy test at screening.
- Normal cardiac and pulmonary function as evidenced by a normal electrocardiogram (ECG) and peripheral oxygen saturation (SpO2) ≥90% by pulse oximetry
Who cannot join
- Previous treatment with inhibitors of immunocheckpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody) or other agents specifically targeting T cells
- Radiotherapy treatment within 4 weeks or less prior to veledimex dosing
- Subjects with clinically significant increased intracranial pressure (eg, impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures
- Known immunosuppressive disease, or autoimmune conditions, and/or chronic viral infections (eg, human immunodeficiency virus [HIV], hepatitis)
- Use of systemic antibacterial, antifungal, or antiviral medications for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is allowed perioperatively.
- Use of enzyme inducing antiepileptic drugs (EIAED) within 7 days prior to the first dose of study drug. Note: Levetiracetam (Keppra®) is not an EIAED and is allowed.
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- Other concurrent clinically active malignant disease, requiring treatment, with the exception of non-melanoma cancers of the skin or carcinoma in situ of the cervix or nonmetastatic prostate cancer
- Nursing or pregnant females
- Prior exposure to veledimex
- Use of medications that induce, inhibit, or are substrates of cytochrome p450 (CYP450) 3A4 within 7 days prior to veledimex dosing without consultation with the Medical Monitor
- Presence of any contraindication for a neurosurgical procedure
- Unstable or clinically significant concurrent medical condition that would, in the opinion of the Investigator or Medical Monitor, jeopardize the safety of a subject and/or their compliance with the protocol. Examples include, but are not limited to: unstable angina, congestive heart failure, myocardial infarction within 2 months of screening, ongoing maintenance therapy for life-threatening ventricular arrhythmia or uncontrolled asthma.
- History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Protocol ATI001-102 Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Combination With Nivolumab in Subjects With Recurrent or Progressive Glioblastoma
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human interleukin-12 (IL-12). IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor.
Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Opdivo (Nivolumab) is currently FDA approved in the United States for melanoma (a type of skin cancer), non-small cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not approved in glioblastoma. Nivolumab may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with Nivolumab to enhance the IL-12 mediated effect observed to date.
The main purpose of this substudy is to evaluate the safety and tolerability of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with nivolumab.
Read the detailed description
Eligible patients will receive one dose of nivolumab, via infusion, one week prior to standard of care craniotomy and tumor resection (subtotal or total). On the day of surgery, patients will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12 will be administered by free-hand injection. Patients will continue on oral veledimex for 14 days. Following veledimex, patients will receive nivolumab via infusion every two weeks.
The study is divided into three periods: the screening period, the treatment period and the follow-up period.
- Conditions
- Glioblastoma
- Being tested
- Ad-RTS-hIL-12, veledimex, Nivolumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad-RTS-hIL-12Biological
- 2.0 x 10^11 viral particles (vp) per injection
- intratumoral injection of Ad-RTS-hIL-12
veledimexDrug
- 2 doses (10mg/day, 20mg/day)
- 15 oral daily doses of veledimex
NivolumabDrug
Also called Opdivo
- 2 doses (1mg/kg, 3mg/kg)
- Every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ad-RTS-hIL-12 + veledimex in combination with nivolumab | Experimental | Intratumoral Ad-RTS-hIL-12 and varying doses of oral veledimex (activator ligand) given in combination with nivolumab via infusion. Receives: Biological: Ad-RTS-hIL-12; Drug: veledimex; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Evaluation of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 will be based on the incidence, intensity and type of adverse event.
AEs will be regarded as treatment-emergent adverse events (TEAEs) during the treatment period regardless of relationship to study drug if:
- The AE occurred or worsened from baseline during or after administration of the first dose of study drug (on or after Day 0).
Measured: 2 years and 4 months
Number of Participants With Veledimex Dose Compliance
Evaluation will be based on expected dose compliance. Subjects were instructed to document veledimex dosing compliance in a subject diary, including the time each dose was taken, the time of the last meal prior to administration of veledimex, the number of capsules taken, whether the subject missed any veledimex doses, and reason for any missed doses. Investigational product container(s) with any remaining capsules were returned to the study staff on Day 15, and staff assessed dose compliance.
Measured: From Day 0 through Day 14 for each participant
Secondary outcomes (15)
Number of Participants With a Dose-Limiting Toxicity (DLT)
The primary objective was to determine the Maximum Tolerated Dose (MTD), defined as the dose at which fewer than 33% of subjects experience a Dose-Limiting Toxicity (DLT). The MTD was not reached; a Maximum Administered Dose (MAD) of 20mg veledimex and 3mg/kg nivolumab was determined. This measure reports the number of subjects who experienced a DLT during the first treatment cycle in each dose cohort.
Measured: The first treatment cycle (21 days).
Tumor Objective Response Rate (ORR)
To determine investigator assessment of response including tumor ORR of Ad-RTS-hIL-12 + veledimex when administered in combination with nivolumab. Investigator assessment of ORR was determined according to Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria. iRANO is a set of criteria built on RANO criteria but adapts them for immune-related effects to evaluate treatment response in brain tumor patients receiving immunotherapy. It addresses unique challenges like pseudoprogression, where immune-related inflammation mimics tumor growth on imaging allowing continued treatment despite early radiographic worsening if the patient is clinically stable. This criteria requires confirmation of progression with follow-up imaging ≥3 months later, especially within the first 6 months of immunotherapy.
Measured: 2 years and 4 months
Progression Free Survival (PFS)
PFS is the time in days from the first treatment (either veledimex or Ad-RTS-hIL-12) to the first assessment on which the overall response is reported as disease progression (per Response Assessment in Neuro-Oncology [RANO] or Immunotherapy Response Assessment in Neuro-Oncology [iRANO] criteria). Subjects withdrawing from the study will be censored at their last non progressive disease response assessment. If a subject does not have a non-progressive disease response assessment, the subject will be censored on the date of the first treatment as described above.
Measured: 2 years and 4 months
Rate of Pseudo-progression (PSP)
PSP -- Progression free survival was originally defined for determination of PSP requiring confirmation of progression (per Response Assessment in Neuro-Oncology [RANO] or Immunotherapy Response Assessment in Neuro-Oncology [iRANO] criteria).
Measured: 2 years and 4 months
Overall Survival (OS)
The percentage of participants alive at each time point (6, 9, 12, 15, 18, and 24 months) are reported.
Measured: Up to 24 months
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Nivolumab.
Blood samples for pharmacodynamic biomarker evaluation were collected at screening, during treatment, and post-treatment. The immunological and biological response markers include serum cytokines (IL-12 and IFNℽ), and T and B cell subpopulations. Serum IL-12 and downstream IFNℽ expressions are reported by time point.
Measured: From Screening through Day 28, assessed at Screening and Days 0, 1, 3, 7, 14, and 28
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Nivolumab.
Blood samples for pharmacodynamic biomarker evaluation were collected at screening, during treatment, and post-treatment.
Whole blood flow cytometry was used to assess the circulating blood cell subpopulations (e.g., T-reg and T cell panels).
Measured: From Screening through Day 28, assessed at Screening, Days 0, 14, and 28
Veledimex Pharmacokinetic Profile: Maximum Plasma Concentration (Cmax)
Cmax was determined from the maximum plasma concentration from Day 0 (post veledimex and resection/craniotomy), 3-5 hours after the veledimex dose on Day 1, and 3-5 hours after the veledimex dose on Day 14.
Measured: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax)
Tmax was determined from the time of maximum plasma concentration from Day 0 (post veledimex and resection/craniotomy), 3-5 hours after the veledimex dose on Day 1, and 3-5 hours after the veledimex dose on Day 14.
Measured: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Half-life (t1/2)
t1/2 was determined from the plasma concentrations measured from Day 0 (post veledimex and resection/craniotomy) through Day 15 (24 hours post Day 14 dose)
Measured: Day 0 to Day 15 (24 hours post Day 14 dose)
Veledimex Pharmacokinetic Profile: Area Under the Concentration-versus-time Curve (AUC)
AUC was determined from the plasma concentrations measured from Day 0 (post veledimex and resection/craniotomy) through Day 15 (24 hours post Day 14 dose)
Measured: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Volume of Distribution (Vd)
Vd was determined from the plasma concentrations measured from Day 0 (post veledimex and resection/craniotomy) through Day 15 (24 hours post Day 14 dose).
Measured: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Clearance (CL)
CL was determined from the plasma concentrations measured from Day 0 (post veledimex and resection/craniotomy) through Day 15 (24 hours post Day 14 dose).
Measured: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Concentration Ratio Between the Brain Tumor and the Blood.
Tumor/plasma ratio at Day 0 by cohort
Measured: 1 day (Day 0 at time of resection)
Cumulative Dexamethasone Use During Days 0-14
To assess concomitant corticosteroid use during the first treatment cycle, the cumulative dose of dexamethasone administered to each subject from Day 0 to Day 14 was calculated. This measure reports the mean cumulative dose in milligrams (mg) for each cohort
Measured: Days 0 through 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start18 Jun 2018
- Primary completion15 Oct 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaymes Holland, Study director, Alaunos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636477
- Sponsor's protocol ID
- ATI001-102 CPI Substudy 1.0
- Status last verified
- Aug 2025
- First submitted
- 5 Jul 2018
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chiocca EA, Gelb AB, Chen CC, Rao G, Reardon DA, Wen PY, Bi WL, Peruzzi P, Amidei C, Triggs D, Seften L, Park G, Grant J, Truman K, Buck JY, Hadar N, Demars N, Miao J, Estupinan T, Loewy J, Chadha K, Tringali J, Cooper L, Lukas RV. Combined immunotherapy with controlled interleukin-12 gene therapy and immune checkpoint blockade in recurrent glioblastoma: An open-label, multi-institutional phase I trial. Neuro Oncol. 2022 Jun 1;24(6):951-963. doi: 10.1093/neuonc/noab271.
PubMed 34850166
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol ATI001-102 Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Combination With Nivolumab in Subjects With Recurrent or Progressive Glioblastoma
- ClinicalTrials.gov ID
- NCT03636477
- Acronym / sponsor ID
- ATI001-102 CPI Substudy 1.0
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human interleukin-12 (IL-12). IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor.
Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Opdivo (Nivolumab) is currently FDA approved in the United States for melanoma (a type of skin cancer), non-small cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not approved in glioblastoma. Nivolumab may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with Nivolumab to enhance the IL-12 mediated effect observed to date.
The main purpose of this substudy is to evaluate the safety and tolerability of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with nivolumab.
Detailed description
Eligible patients will receive one dose of nivolumab, via infusion, one week prior to standard of care craniotomy and tumor resection (subtotal or total). On the day of surgery, patients will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12 will be administered by free-hand injection. Patients will continue on oral veledimex for 14 days. Following veledimex, patients will receive nivolumab via infusion every two weeks.
The study is divided into three periods: the screening period, the treatment period and the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ad-RTS-hIL-12 + veledimex in combination with nivolumab | Experimental | Biological: Ad-RTS-hIL-12, Drug: veledimex, Drug: NivolumabIntratumoral Ad-RTS-hIL-12 and varying doses of oral veledimex (activator ligand) given in combination with nivolumab via infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female subject ≥18 and ≤75 years of age
- Provision of written informed consent for tumor resection, stereotactic surgery, tumor biopsy, samples collection, and treatment with investigational products prior to undergoing any study specific procedures
- Histologically confirmed supratentorial glioblastoma
- Evidence of tumor recurrence/progression by magnetic resonance imaging (MRI) according to response assessment in neuro-oncology (RANO) criteria after standard initial therapy
- Previous standard-of-care antitumor treatment including surgery and/or biopsy and chemoradiation. At the time of registration, subjects must have recovered from the toxic effects of previous treatments as determined by the treating physician. The washout periods from prior therapies are intended as follows: (windows other than what is listed below should be allowed only after consultation with the Medical Monitor)
Key exclusion criteria (13 listed)
- Previous treatment with inhibitors of immunocheckpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody) or other agents specifically targeting T cells
- Radiotherapy treatment within 4 weeks or less prior to veledimex dosing
- Subjects with clinically significant increased intracranial pressure (eg, impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures
- Known immunosuppressive disease, or autoimmune conditions, and/or chronic viral infections (eg, human immunodeficiency virus [HIV], hepatitis)
- Use of systemic antibacterial, antifungal, or antiviral medications for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is allowed perioperatively.
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 |
|---|---|---|
| Ad-RTS-hIL-12* 2.0 x 10^11 viral particles (vp) per injection * intratumoral injection of Ad-RTS-hIL-12 | Biological | Ad-RTS-hIL-12 + veledimex in combination with nivolumab |
| veledimex* 2 doses (10mg/day, 20mg/day) * 15 oral daily doses of veledimex | Drug | Ad-RTS-hIL-12 + veledimex in combination with nivolumab |
| NivolumabAlso: Opdivo* 2 doses (1mg/kg, 3mg/kg) * Every 2 weeks | Drug | Ad-RTS-hIL-12 + veledimex in combination with nivolumab |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 2 years and 4 months
Evaluation of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 will be based on the incidence, intensity and type of adverse event. AEs will be regarded as treatment-emergent adverse events (TEAEs) during the treatment period regardless of relationship to study drug if: • The AE occurred or worsened from baseline during or after administration of the first dose of study drug (on or after Day 0).
Number of Participants With Veledimex Dose Compliance
Time frame: From Day 0 through Day 14 for each participant
Evaluation will be based on expected dose compliance. Subjects were instructed to document veledimex dosing compliance in a subject diary, including the time each dose was taken, the time of the last meal prior to administration of veledimex, the number of capsules taken, whether the subject missed any veledimex doses, and reason for any missed doses. Investigational product container(s) with any remaining capsules were returned to the study staff on Day 15, and staff assessed dose compliance.
15 secondary outcomes
Number of Participants With a Dose-Limiting Toxicity (DLT)
Time frame: The first treatment cycle (21 days).
Tumor Objective Response Rate (ORR)
Time frame: 2 years and 4 months
Progression Free Survival (PFS)
Time frame: 2 years and 4 months
Rate of Pseudo-progression (PSP)
Time frame: 2 years and 4 months
Overall Survival (OS)
Time frame: Up to 24 months
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Nivolumab.
Time frame: From Screening through Day 28, assessed at Screening and Days 0, 1, 3, 7, 14, and 28
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Nivolumab.
Time frame: From Screening through Day 28, assessed at Screening, Days 0, 14, and 28
Veledimex Pharmacokinetic Profile: Maximum Plasma Concentration (Cmax)
Time frame: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax)
Time frame: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Half-life (t1/2)
Time frame: Day 0 to Day 15 (24 hours post Day 14 dose)
Veledimex Pharmacokinetic Profile: Area Under the Concentration-versus-time Curve (AUC)
Time frame: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Volume of Distribution (Vd)
Time frame: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Pharmacokinetic Profile: Clearance (CL)
Time frame: Day 0 to Day 15 (Day 14 24-hour post dose)
Veledimex Concentration Ratio Between the Brain Tumor and the Blood.
Time frame: 1 day (Day 0 at time of resection)
Cumulative Dexamethasone Use During Days 0-14
Time frame: Days 0 through 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34850166Chiocca EA, Gelb AB, Chen CC, Rao G, Reardon DA, Wen PY, Bi WL, Peruzzi P, Amidei C, Triggs D, Seften L, Park G, Grant J, Truman K, Buck JY, Hadar N, Demars N, Miao J, Estupinan T, Loewy J, Chadha K, Tringali J, Cooper L, Lukas RV. Combined immunotherapy with controlled interleukin-12 gene therapy and immune checkpoint blockade in recurrent glioblastoma: An open-label, multi-institutional phase I trial. Neuro Oncol. 2022 Jun 1;24(6):951-963. doi: 10.1093/neuonc/noab271.
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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. This study is not recruiting at the moment.
Jaymes Holland study director
Alaunos Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad-RTS-hIL-12, veledimex and Nivolumab in people with Glioblastoma, run by Alaunos Therapeutics at 4 sites 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 23 inclusion and 13 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: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: 2 years and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03636477, which also lists 1 linked publication.
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 12 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.