GlioblastomaPhase 1NCT03679754
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
A Phase 1 study testing Ad-RTS-hIL-12 and veledimex 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 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. 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 and veledimex
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Sep 2018to 19 Jan 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, tumor biopsy, samples collection, and treatment with investigational products prior to undergoing any study specific procedures
- Histologically confirmed glioblastoma
- Evidence of supratentorial 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: 4 weeks (NOTE: short use (< 4 doses) of bevacizumab for controlling edema is allowed)
- 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) or partial thromboplastin time (PTT) 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
Who cannot join
- Previous treatment with bevacizumab for their disease (NOTE: short use (< 4 doses) of bevacizumab for controlling edema is allowed)
- Subjects receiving systemic corticosteroids during the previous 4 weeks
- Radiotherapy treatment within 4 weeks of starting veledimex
- 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
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- 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
- 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 CYP4503A4 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 may include, but are not limited to, colitis, pneumonitis, unstable angina, congestive heart failure, myocardial infarction within 2 months of screening, and ongoing maintenance therapy for life-threatening ventricular arrhythmia or uncontrolled asthma
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
NYU - Langone Health
New York, New York, 10016
About this study
Official title: Protocol ATI001-102 Expansion Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex 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 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.
The main purpose of this study is to evaluate the safety and tolerability of a single intratumoral injection of Ad-RTS-hIL-12 given with oral veledimex.
Read the detailed description
Patients who are scheduled for craniotomy and tumor resection 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.
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
- 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
- 20mg/day
- 15 oral daily doses of veledimex
| Study group | Role | What they receive |
|---|---|---|
| Ad-RTS-hIL-12 + veledimex | Experimental | Intratumoral Ad-RTS-hIL-12 and oral veledimex Receives: Biological: Ad-RTS-hIL-12; Drug: veledimex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Evaluation of adverse events as assessed by CTCAE v4.03. Adverse events will be summarized based on the incidence, intensity and type of adverse event.
Measured: From the first dose of study treatment until 30 days after the last dose of veledimex, lasting approximately 5 months.
Tolerability of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Will be Assessed Based on Expected Dose Compliance
The Day 0 (as applicable), and Day 1 doses of veledimex were administered by study personnel at the study center.
Thereafter, subjects could self-administer the remaining once daily dose of veledimex. Subjects were instructed to document veledimex dosing compliance in a subject diary, including the time each dose was taken, the time the subject ate 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: Days 1 through 14 of each 21-day treatment cycle, over a total treatment period of up to 6 cycles (approximately 4 months)
Secondary outcomes (14)
Determine the Overall Survival (OS) of Ad-RTS-hIL-12 + Veledimex
OS is defined as the duration of time from the first dose of study drug (Day 0) to the date of death from any cause in days or months. Subjects are censored based on the last date known to be alive. For example:
- Subjects who discontinue the study without documentation of additional follow-up will be censored at the date of discontinuation.
- Subjects who are lost to follow-up will be censored at last follow-up contact date.
- Subjects still alive up to 2 years from the first dose of study drug are classified as censored and as having completed all follow-up scheduling.
Measured: From the first dose of study drug for up to 2 years.
Veledimex Pharmacokinetic Profile: Maximum Plasma Concentration (Cmax)
The maximum plasma concentration (Cmax) of veledimex
Measured: 15 days
Veledimex Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration (Tmax) of veledimex. Tmax was estimated based on time of maximum concentration (Cmax) from predose (Day 0 or 14) to predose the following day (Day 1 or 15).
Measured: 15 days
Veledimex Pharmacokinetic Profile: Half-life (t1/2)
Half-life (t1/2) of veledimex
Measured: 15 days
Veledimex Pharmacokinetic Profile: Area-under-the-concentration Versus Time Curve (AUC)
Area-under-the-concentration versus time curve (AUC) of veledimex from Day 14 predose to Day 15 predose. AUC was estimated using the elimination rate constant k, where k = ln(Cmax/Ctrough)/time difference and AUC is approximately Cmax/k.
Measured: 15 days
Veledimex Pharmacokinetic Profile: Volume of Distribution (Vd)
Volume of distribution (Vd) of veledimex. Vd was calculated using AUC approximated as described in the Outcome Measure Description for Outcome Measure 6.
Measured: 15 days
Veledimex Pharmacokinetic Profile: Clearance (CL)
Clearance (CL) of veledimex. CL was calculated using AUC approximated as described in the Outcome Measure Description for Outcome Measure 6.
Measured: 15 days
Veledimex Concentration Ratio Between the Brain Tumor and the Blood
Veledimex concentration ratio was calculated based on the Day 0 tumor and plasma PK results.
Measured: Day 0 (at the time of tumor resection)
Tumor Objective Response Rate (ORR)
For the ORR calculation, responders are defined as those experiencing a confirmed complete response or confirmed partial response. Non-responders are those either with stable or progressive disease. Those subjects that cannot be assessed will be treated as non-responders for the purposes of deriving the percentage of responders and confidence intervals. Overall Response was assessed at multiple timepoints (day 56, week 16, week 24, and week 48) by the study investigators.
Changes to the original plan for exploration of estimates of efficacy are summarized below.
- The best overall response (BOR) endpoint was added to the efficacy assessment and reported here.
Measured: 48 weeks
Progression Free Survival (PFS)
PFS (progression free survival) is the time in months 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. 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: From the first dose of study drug for up to 2 years.
Rate of Pseudo-progression (PSP)
PSP Progression free survival was originally defined for determination of PSP requiring confirmation of progression based on RANO/iRANO criteria guidelines.
Measured: From the first dose of study drug for up to 2 years.
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex
Evaluation in changes in immune cell population markers, such as CD3 and CD8 in tumor
Measured: Baseline and Week 6.
Peak Serum Concentration of Interleukin-12 (IL-12)
Serum concentrations of IL-12 were measured at multiple timepoints post-dose. For each participant, the peak (maximum) concentration observed from Day 3 through the 30-day follow-up visit was identified. This measure summarizes the mean of those individual peak concentrations.
Measured: Samples were collected at Baseline (Day 1), Day 3, Day 8, and Day 15 of Cycle 1, and at the 30-day follow-up visit.
Peak Serum Concentration of Interferon-gamma (IFN-γ)
Serum concentrations of IFN-γ were measured at multiple timepoints post-dose. For each participant, the peak (maximum) concentration observed from Day 3 through the 30-day follow-up visit was identified. This measure summarizes the mean of those individual peak concentrations.
Measured: Samples were collected at Baseline (Day 1), Day 3, Day 8, and Day 15 of Cycle 1, and at the 30-day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start5 Sep 2018
- Primary completion2 Apr 2019
- Study completion19 Jan 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.
- 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
- 36 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
- NCT03679754
- Sponsor's protocol ID
- ATI001-102 EXP Substudy 2.0
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2018
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol ATI001-102 Expansion Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma
- ClinicalTrials.gov ID
- NCT03679754
- Acronym / sponsor ID
- ATI001-102 EXP Substudy 2.0
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 28 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 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.
The main purpose of this study is to evaluate the safety and tolerability of a single intratumoral injection of Ad-RTS-hIL-12 given with oral veledimex.
Detailed description
Patients who are scheduled for craniotomy and tumor resection 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.
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 | Experimental | Biological: Ad-RTS-hIL-12, Drug: veledimexIntratumoral Ad-RTS-hIL-12 and oral veledimex |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female subject ≥18 and ≤75 years of age
- Provision of written informed consent for tumor resection, tumor biopsy, samples collection, and treatment with investigational products prior to undergoing any study specific procedures
- Histologically confirmed glioblastoma
- Evidence of supratentorial 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 bevacizumab for their disease (NOTE: short use (< 4 doses) of bevacizumab for controlling edema is allowed)
- Subjects receiving systemic corticosteroids during the previous 4 weeks
- Radiotherapy treatment within 4 weeks of starting veledimex
- 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)
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 |
| veledimex* 20mg/day * 15 oral daily doses of veledimex | Drug | Ad-RTS-hIL-12 + veledimex |
Primary outcome
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event.
Time frame: From the first dose of study treatment until 30 days after the last dose of veledimex, lasting approximately 5 months.
Evaluation of adverse events as assessed by CTCAE v4.03. Adverse events will be summarized based on the incidence, intensity and type of adverse event.
Tolerability of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Will be Assessed Based on Expected Dose Compliance
Time frame: Days 1 through 14 of each 21-day treatment cycle, over a total treatment period of up to 6 cycles (approximately 4 months)
The Day 0 (as applicable), and Day 1 doses of veledimex were administered by study personnel at the study center. Thereafter, subjects could self-administer the remaining once daily dose of veledimex. Subjects were instructed to document veledimex dosing compliance in a subject diary, including the time each dose was taken, the time the subject ate 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.
14 secondary outcomes
Determine the Overall Survival (OS) of Ad-RTS-hIL-12 + Veledimex
Time frame: From the first dose of study drug for up to 2 years.
Veledimex Pharmacokinetic Profile: Maximum Plasma Concentration (Cmax)
Time frame: 15 days
Veledimex Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax)
Time frame: 15 days
Veledimex Pharmacokinetic Profile: Half-life (t1/2)
Time frame: 15 days
Veledimex Pharmacokinetic Profile: Area-under-the-concentration Versus Time Curve (AUC)
Time frame: 15 days
Veledimex Pharmacokinetic Profile: Volume of Distribution (Vd)
Time frame: 15 days
Veledimex Pharmacokinetic Profile: Clearance (CL)
Time frame: 15 days
Veledimex Concentration Ratio Between the Brain Tumor and the Blood
Time frame: Day 0 (at the time of tumor resection)
Tumor Objective Response Rate (ORR)
Time frame: 48 weeks
Progression Free Survival (PFS)
Time frame: From the first dose of study drug for up to 2 years.
Rate of Pseudo-progression (PSP)
Time frame: From the first dose of study drug for up to 2 years.
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex
Time frame: Baseline and Week 6.
Peak Serum Concentration of Interleukin-12 (IL-12)
Time frame: Samples were collected at Baseline (Day 1), Day 3, Day 8, and Day 15 of Cycle 1, and at the 30-day follow-up visit.
Peak Serum Concentration of Interferon-gamma (IFN-γ)
Time frame: Samples were collected at Baseline (Day 1), Day 3, Day 8, and Day 15 of Cycle 1, and at the 30-day follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 and veledimex 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 22 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 28 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 28 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?
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Subjects With Recurrent or Progressive Glioblastoma Based on Evaluation of Adverse Events Summarized by Incidence, Intensity and Type of Adverse Event. (time frame: From the first dose of study treatment until 30 days after the last dose of veledimex, lasting approximately 5 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?
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 28 Aug 2025.