Recurrent GlioblastomaPhase 1NCT06917885
CUE-102 in Recurrent Glioblastoma
A Phase 1 study testing CUE-102 in people with Recurrent Glioblastoma and Glioblastoma, run by David Reardon, MD at 2 sites in United States.
Trial summary
The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM). The name of the study drug involved in this study is: -CUE-102 (a type of fusion protein) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma, Glioblastoma, Glioma, Malignant
- What is being tested?
- CUE-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jul 2025to 31 Jan 2028
- 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
- Have HLA-A*0201 genotype as determined by genomic testing performed locally;
- Have histologically confirmed World Health Organization (WHO) Grade 4 glioblastoma, other WHO grade 4 malignant glioma or molecular GBM (based on the 2021 WHO Classification) at first recurrence. Patients with gliosarcoma are NOT eligible;
- Be willing and able to provide written informed consent/assent for the trial;
- Be ≥ 18 years of age on day of signing informed consent;
- Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A);
- Participants must be at least 4 weeks from start of last chemotherapy cycle (at least 6 weeks for nitrosoureas and at least 1 week for metronomic dosing) and at least 4 weeks or 5 half-lives (whichever is shorter) for any prior investigational agent. There is no minimal time from cessation of Optune TTF nor for prior cancer vaccine therapy.
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- MRI within 14 days prior to registration. MRIs should include vascular imaging when possible. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening MRI scan and the start of treatment, a new baseline MRI or CT is required;
- Patients must have fully completed initial radiation therapy with or without daily temozolomide including 60 Gy in 30 fractions, 59.4 Gy in 1.8 Gy per fraction or equivalent;
- At least 12 weeks from completion of radiotherapy +/- temozolomide. Patients < 12 weeks from the completion of radiation therapy may be eligible if they have either of the following: 1) histopathologic confirmation of recurrent tumor; or 2) new contrast enhancing disease outside the primary radiation field. Participants who have received investigational therapies as a component of treatment for newly diagnosed GBM as long as remaining eligibility criteria are satisfied;
- Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (exceptions include alopecia, laboratory values listed per inclusion criteria, and lymphopenia, which is common after therapy with temozolomide);
- Participants must meet the following organ and marrow function as defined below, all screening labs should be performed within 14 days of registration:
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)
- Serum creatinine ≤ 1.5 X institutional ULN OR
- Measured or calculated creatinine clearance (CrCl) ≥45 mL/min for participant with creatinine levels > 1.5 X institutional ULN (CrCl should be calculated per institutional standard, GFR can also be used in place of creatinine or CrCl)
- Serum total bilirubin ≤ 1.5 X institutional ULN OR
- Direct bilirubin ≤ institutional ULN for participants with total bilirubin levels > 1.5 X institutional ULN
- AST (SGOT) and ALT (SGPT) ≤ 3.0 X institutional ULN OR ≤ 5 X institutional ULN for participants with Gilberts syndrome
- International Normalized Ratio (INR) OR Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 X institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- Resting baseline oxygen saturation by pulse oximetry ≥92% at rest
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative urine or serum pregnancy within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
- --Women in the following categories are not considered WOCBP:
- Premenarchal
- Premenopausal female with 1 of the following:
- Documented hysterectomy
- Documented bilateral salpingectomy
- Documented bilateral oophorectomy
- Note: Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical history interview.
- Postmenopausal female
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- -----A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.
- Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
- Women of child-bearing potential (WOCBP; see definition above), must agree to use a highly effective method of contraception consistently and correctly as described below during study treatment and for 120 days after study treatment discontinuation or the initiation of other cancer therapy (whichever is shorter);
- Highly Effective Contraceptive Methods That Are User Dependent a (Failure rate of < 1% per year when used consistently and correctly.)
- Combined (estrogen- and progestogen- containing) hormonal contraception
- i. Oral
- ii. Intravaginal
- iii. Transdermal
- iv. Injectable
- Progestogen-only hormonal contraception
- v. Oral
- vi. Injectable
- Highly Effective Methods That Have Low User Dependency (Failure rate of <1% per year when used consistently and correctly)
- Progestogen- only contraceptive implant
- Intrauterine hormone-releasing system (IUS) Intrauterine device (IUD)
- Bilateral tubal occlusion
- Vasectomized partner (A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used).
- Sexual abstinence (Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant).
- NOTES: Use should be consistent with local regulations regarding the use of contraceptive methods for participants of clinical studies.
- a. Typical use failure rates are lower than perfect-use failure rates (i.e. when used consistently and correctly).
- b. If hormonal contraception efficacy is potentially decreased due to interaction with study treatment, condoms must be used in addition to the hormonal contraception during the treatment period and for at least during study treatment and for 120 days after study treatment discontinuation after the last dose of study treatment or the initiation of other cancer therapy (whichever is shorter).
- c. If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive implants are limited to those which inhibit ovulation.
- Male participants must agree to use at least one of the following methods of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy or the initiation of other cancer therapy (whichever is shorter):
- Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- Use a male condom plus partner use of a contraceptive method with a failure rate of <1% per year when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.
- a. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration.
Who cannot join
- Received any therapy for tumor recurrence other than surgery;
- More than one episode of recurrent or progressive tumor;
- Is currently participating or plans to participate in another study of an investigational agent or using an investigational device.
- Tumor primarily localized to the brainstem or spinal cord;
- Presence of multifocal tumor, bi-hemispheric tumor (radiographic evidence of tumor extending from one hemisphere into the other through the corpus callosum), diffuse leptomeningeal or extracranial disease;
- Has a diagnosis of immunodeficiency;
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- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. Examples include - but are not limited to - unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements;
- Has history of known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of enrollment;
- Has evidence of intratumoral or peritumoral hemorrhage on baseline MRI scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans;
- Has gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE Grade > 3 within 6 months of enrollment;
- Has a known additional malignancy that is progressing or requires active treatment within 1 year of start of study drug, except for those treated with surgical therapy only (e.g. basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy);
- Has active autoimmune disease requiring systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg thyroxine, insulin, or physiologic corticosteroid replacement for adrenal insufficiency or pituitary/hypothalamic dysfunction, etc.) is not considered a form of systemic treatment;
- Has history of (non-infectious) pneumonitis that required steroids or has current pneumonitis;
- Has an active infection requiring systemic therapy within 7 days before enrollment;
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) and is receiving antiretroviral therapy.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);
- Has a history of non-healing wounds or ulcers, or bone refractures within 3 months of fracture;
- Has a history of arterial thromboembolism within 12 months of enrollment;
- Has had clinically significant cardiovascular disease within 12 months of start of study drug, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent;
- Has a known history of active TB (Bacillus Tuberculosis);
- Has a known hypersensitivity to any of the study therapy products and/or any of their excipients;
- Is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment or the initiation of other cancer therapy (whichever is shorter). Pregnant women are excluded because there is an unknown but potential risk for adverse events affecting a developing fetus and/or the mother secondary to treatment with CUE-102. There is also an unknown but potential risk for adverse events affecting nursing infants secondary to treatment of the mother with CUE-102, thus, breastfeeding must be discontinued if the mother is treated with CUE-102;
- Is receiving any form of immunosuppressive therapy (e.g. chronic systemic steroid therapy exceeding dosage of 10 mg daily of prednisone equivalent) within 7 days prior to enrollment;
- Has received systemic immunosuppressive treatments, aside from systemic corticosteroids (such as methotrexate, chloroquine, azathioprine, etc), within six months of enrollment;
- Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent for at least 3 consecutive days within 2 weeks of enrollment;
- Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption).
- Physiologic replacement doses of systemic corticosteroids are permitted, ≤10 mg/day prednisone equivalents.
- A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to enrollment; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed;
- Has received a live vaccine within 30 days prior to enrollment;
- Examples of live vaccines include - but are not limited to - the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- History of acute pancreatitis within 3 months before enrollment;
- Diverticulitis that is clinically significant in the opinion of the Investigator based on the extent or severity of known disease and/or the occurrence of clinically significant flares within 4 weeks before enrollment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
David A Reardon, MD, 617-632-4750, david_reardon@dfci.harvard.edu
David A Reardon, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
David A Reardon, MD, 647-632-4750, david_reardon@dfci.harvard.edu
David A Reardon, MD
About this study
Official title: Phase Ib Open-label Study of Adjuvant CUE-102, a WT-1-pHLA-IL2-Fc Fusion Protein in Glioblastoma (GBM) Patients at First Recurrence
The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM).
The name of the study drug involved in this study is:
-CUE-102 (a type of fusion protein)
Read the detailed description
This is a single center, open-label, Phase Ib trial evaluating the safety and tolerability of CUE-102 monotherapy in adult participants with Glioblastoma (GBM) at first recurrence. CUE-102 is designed to target tumor cells by activating T cells, potentially improving clinical outcomes in recurrent GBM.
The U.S. Food and Drug Administration (FDA) has not approved CUE-102 as a treatment for Recurrent Glioblastoma.
The research study procedures include screening for eligibility, in-clinic visits, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, blood and urine tests, and electrocardiograms (ECG).
It is expected that about 18 people will take part in this research study.
Cue Biopharma, Inc. is supporting this research study by providing the study drug, CUE-102.
- Conditions
- Recurrent Glioblastoma, Glioblastoma, Glioma, Malignant
- Being tested
- CUE-102
- Keywords
- Glioblastoma, Recurrent Glioblastoma, Glioma, Malignant
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUE-102Biological
A WT-1-pHLA-IL2-Fc fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.
| Study group | Role | What they receive |
|---|---|---|
| CUE-102 | Experimental | The first 12 participants will be enrolled using a standard 3 + 3 design in a safety lead-in to determine the maximum tolerated dose (MTD) of CUE-102 per protocol. Once the MTD has been determined, up to 6 additional participants will be enrolled in a dose expansion cohort. Participants will complete:
* Baseline visit
* Imaging every 9 weeks starting at Cycle 3
* Cycle 1 through End of Treatment (up to 1 year in total, approximately 17 cycles)
--Day 1 of 21 day cycle: Predetermined dose of CUE-102 1x daily.
* End of Treatment visit with imaging
* Long-Term Follow Up: every 3-4 months Receives: Biological: CUE-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-limiting-toxicities (DLT)
A DLT is defined as any adverse event (AE) considered related to CUE-102 that meets DLT criteria in the 21-day period following the first dose of CUE-102 including pre-treatment laboratory results required for C2D1.
Measured: 3 weeks
Maximum Tolerated Dose (MTD)
MTD is determined using a 3+3 design as listed in protocol section 1.1
Measured: 3 weeks
Secondary outcomes (1)
Safety and tolerability
safety and tolerability as measured by CTCAEv5.0 including clinical, laboratory, EKG and radiographic assessments.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start30 Jul 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Reardon, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Cue Biopharma
- Responsible party
- Sponsor-investigator, David Reardon, MD, Dana-Farber Cancer Institute
- Investigators
- David Reardon, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917885
- Sponsor's protocol ID
- 25-023
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Open-label Study of Adjuvant CUE-102, a WT-1-pHLA-IL2-Fc Fusion Protein in Glioblastoma (GBM) Patients at First Recurrence
- ClinicalTrials.gov ID
- NCT06917885
- Acronym / sponsor ID
- 25-023
- Conditions
- Recurrent Glioblastoma, Glioblastoma, Glioma, Malignant
- Keywords
- Glioblastoma, Recurrent Glioblastoma, Glioma, Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- David Reardon, MDUniversity, hospital or other
- Collaborators
- Cue Biopharma
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 Apr 2025 (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.
The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM).
The name of the study drug involved in this study is:
-CUE-102 (a type of fusion protein)
Detailed description
This is a single center, open-label, Phase Ib trial evaluating the safety and tolerability of CUE-102 monotherapy in adult participants with Glioblastoma (GBM) at first recurrence. CUE-102 is designed to target tumor cells by activating T cells, potentially improving clinical outcomes in recurrent GBM.
The U.S. Food and Drug Administration (FDA) has not approved CUE-102 as a treatment for Recurrent Glioblastoma.
The research study procedures include screening for eligibility, in-clinic visits, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, blood and urine tests, and electrocardiograms (ECG).
It is expected that about 18 people will take part in this research study.
Cue Biopharma, Inc. is supporting this research study by providing the study drug, CUE-102.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUE-102 | Experimental | Biological: CUE-102The first 12 participants will be enrolled using a standard 3 + 3 design in a safety lead-in to determine the maximum tolerated dose (MTD) of CUE-102 per protocol. Once the MTD has been determined, up to 6 additional participants will be enrolled in a dose expansion cohort. Participants will complete: * Baseline visit * Imaging every 9 weeks starting at Cycle 3 * Cycle 1 through End of Treatment (up to 1 year in total, approximately 17 cycles) --Day 1 of 21 day cycle: Predetermined dose of CUE-102 1x daily. * End of Treatment visit with imaging * Long-Term Follow Up: every 3-4 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (57 listed)
- Have HLA-A*0201 genotype as determined by genomic testing performed locally;
- Have histologically confirmed World Health Organization (WHO) Grade 4 glioblastoma, other WHO grade 4 malignant glioma or molecular GBM (based on the 2021 WHO Classification) at first recurrence. Patients with gliosarcoma are NOT eligible;
- Be willing and able to provide written informed consent/assent for the trial;
- Be ≥ 18 years of age on day of signing informed consent;
- Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A);
Key exclusion criteria (35 listed)
- Received any therapy for tumor recurrence other than surgery;
- More than one episode of recurrent or progressive tumor;
- Is currently participating or plans to participate in another study of an investigational agent or using an investigational device.
- Tumor primarily localized to the brainstem or spinal cord;
- Presence of multifocal tumor, bi-hemispheric tumor (radiographic evidence of tumor extending from one hemisphere into the other through the corpus callosum), diffuse leptomeningeal or extracranial disease;
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 |
|---|---|---|
| CUE-102A WT-1-pHLA-IL2-Fc fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol. | Biological | CUE-102 |
Primary outcome
Number of Participants Experiencing Dose-limiting-toxicities (DLT)
Time frame: 3 weeks
A DLT is defined as any adverse event (AE) considered related to CUE-102 that meets DLT criteria in the 21-day period following the first dose of CUE-102 including pre-treatment laboratory results required for C2D1.
Maximum Tolerated Dose (MTD)
Time frame: 3 weeks
MTD is determined using a 3+3 design as listed in protocol section 1.1
1 secondary outcome
Safety and tolerability
Time frame: Up to 1 year
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 5 Mar 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
David Reardon, MD principal investigator
Dana-Farber Cancer Institute
2 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 CUE-102 in people with Recurrent Glioblastoma and Glioblastoma, run by David Reardon, MD at 2 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 57 inclusion and 35 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 David Reardon, MD (617-632-4750, david_reardon@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-limiting-toxicities (DLT) (time frame: 3 weeks). 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 5 Mar 2026.