GlioblastomaPhase 1/2PRIDENCT04922723
Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma
A Phase 1/2 study testing Daratumumab in people with Glioblastoma, run by West Virginia University at 1 site in United States.
Trial summary
TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the preclinical data along with existing in vivo studies by others provides the rationale for therapeutic targeting of CD38 in GBM and its… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to Dec 2026
- Phase
- Phase 1/2
- 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
- Subjects must have high radiological likelihood of GBM with plan for resection/biopsy for histologically confirmed GBM
- ECOG Performance status ≤ 2
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count ≥ 100,000/mcL
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- Total bilirubin within normal institutional limits
- AST (SGOT) ≤ 3 X institutional upper limit of normal
- ALT (SGPT) ≤ 3 X institutional upper limit of normal
- Serum Creatinine within normal institutional limits OR glomerular filtration rate (GFR) 60 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2
- The effects of Daratumumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Daratumumab and TMZ administration.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who received prior treatment for GBM.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Daratumumab and TMZ.
- BCG (Intravesical), Deferiprone, and Dipyrone are risk X category and should be avoided when Daratumumab is used. Chloramphenicol (Ophthalmic), promazine and Clozapine are in the risk category C and myelosuppression signs should be monitored when used in combination with Daratumumab.
- Avoid category Risk X drugs such as BCG (Intravesical), Deferiprone, Dipyrone, Natalizumab, Tacrolimus (Topical), Vaccines (Live) and Pimecrolimus concurrently with TMZ. Consider therapy modifications of category D drugs such as Baricitinib, Echinacea, Fingolimod, Leflunomide, Lenograstim, Lipegfilgrastim, Nivolumab, Palifermin, Roflumilast, Tofacitinib, Vaccines (Inactivated when used with TMZ. Monitor therapy for category risk C drugs such as Chloramphenicol (Ophthalmic), CloZAPine, Coccidioides immitis Skin Test, Denosumab, Ocrelizumab, Pidotimod, Promazine, Sipuleucel-T, Trastuzumab, and Valproate Products.
- Patients with uncontrolled intercurrent illness.
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- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because there are no animal and human data to assess the risk of Daratumumab during pregnancy. On the other hand, TMZ is a category D drug where adverse events are observed in animal reproduction studies. May cause fetal harm when administered to pregnant females. Male and female patients should use effective contraception to avoid pregnancy while receiving temozolomide. May impair male fertility based on animal data).
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal.
- o Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is <50% of predicted normal.
- Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
- o Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.
- Clinically significant cardiac disease, including:
- Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV).
- Uncontrolled cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
About this study
Official title: A Study of Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma (PRIDE).
TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the preclinical data along with existing in vivo studies by others provides the rationale for therapeutic targeting of CD38 in GBM and its microenvironment. Daratumumab is commercially available, is safe and well tolerated when combined with alkylating chemotherapy, radiation therapy and has attained therapeutic CSF levels. Thus, the addition of Daratumumab to the frontline treatment regimen of GBM can potentially have a significant clinical benefit. Approximately 16 subjects will be enrolled in this trial. Up to 6 will be enrolled in the phase I part and 10 to 13 in the phase II part to come up with a total of 16 patients with 2 phases combined.
Read the detailed description
Glioblastoma (GBM) is an aggressive brain cancer. Current therapeutic strategies include maximal safe surgical resection followed by course of Temozolomide (TMZ) and radiation therapy (RT). Despite trimodality treatment, recurrence remains inevitable. Our study will use Daratumumab, an anti-CD38 monoclonal antibody, in combination with TMZ and RT in newly diagnosed GBM patients. There is pre-clinical evidence suggesting Daratumumab is cytotoxic to GBM in a multimodal fashion, its safe when combined with chemotherapy \& radiation therapy as well as has the potential to cross blood brain barrier.
- Conditions
- Glioblastoma
- Being tested
- Daratumumab
- Keywords
- Immunotherapy, Radiation/Temozolomide, Antitumor Efficacy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called Darzalex
Daratumumab will be administered by IV infusion to subjects in combination with current therapeutic strategies of surgical resection followed by a course of Temozolomide and radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab | Experimental | Daratumumab, IV, 16 mg/KG -
1 dose prior to surgery or biopsy; Weeks 1 - 8 = 1 dose weekly; Weeks 9 - 24 = 1 dose every other week; Weeks 25 onward (determined by disease progression) = 1 dose every 4 weeks Receives: Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT) rate of Daratumumab
Rate of subjects that experience DLT. Subjects will be evaluated for DLTs after 6 doses of Daratumumab. If there is no DLT in the first 3 patients, the investigators will move forward to conduct the phase II clinical trial. If there is a DLT, another three patients will be enrolled. The study may be suspended with additional discussions in the data monitoring committee if there are ≥2 identified DLTs in the first 3 patients or ≥2 DLTs in the first 6 patients. The sample size justification is based on the standard 3+3 design.
Measured: Up to 6 weeks
Phase II - Median overall survival of newly diagnosed GBM patients
Evaluate the median overall survival of newly diagnosed GBM patients. All patients in phase I part will be included in the efficacy analysis on overall survival (OS) in phase II part. If the 1-year survival rate of the study subjects is above 50% (median survival rate), it will be considered that the new intervention is promising.
Measured: Up to 12 months
Secondary outcomes (7)
Phase I - Median overall survival of newly diagnosed GBM patients
Evaluate the median overall survival of newly diagnosed GBM patients. All patients in phase I part will be included in the efficacy analysis on overall survival (OS) in phase II part. If the 1-year survival rate of the study subjects is above 50% (median survival rate), it will be considered that the new intervention is promising.
Measured: Up to 6 weeks
Phase I - Evaluate the Progression-Free Survival (PFS)
Duration of time from start of Daratumumab treatment to time of progression or death, whichever occurs first.
Measured: Up to 6 weeks
Phase I - Assess the treatment-emergent adverse events
Treatment-emergent Adverse Events are events not present prior to the initiation of treatment or any event already present that worsens in either intensity or frequency following the treatment.
Measured: Up to 6 weeks
Phase I - Estimate the tumor response rate
To estimate tumor response rates after treatment with Daratumumab.
Measured: Up to 6 weeks
Phase II - Evaluate the Progression-Free Survival (PFS)
Duration of time from start of Daratumumab treatment to time of progression or death, whichever occurs first.
Measured: Up to 12 months
Phase II - Assess the treatment-emergent adverse events
Treatment-emergent Adverse Events are events not present prior to the initiation of treatment or any event already present that worsens in either intensity or frequency following the treatment.
Measured: Up to 12 months
Phase II - Estimate the tumor response rate
To estimate tumor response rates after treatment with Daratumumab.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start3 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonikpreet Aulakh, West Virginia University
- Investigators
- Sonikpreet Aulakh, MD, Principal investigator, WVU Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922723
- Sponsor's protocol ID
- 2109412076
- Other IDs
- IND# Pending
- Acronym
- PRIDE
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Norouzi S, Aulakh S. CD38 overexpression drives glioblastoma progression via L1CAM/ICAM1/JAK-STAT-Driven tumor microenvironment rewiring. Transl Oncol. 2026 May;67:102758. doi: 10.1016/j.tranon.2026.102758. Epub 2026 Apr 6.
PubMed 41946147
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma (PRIDE).
- ClinicalTrials.gov ID
- NCT04922723
- Acronym / sponsor ID
- PRIDE / 2109412076
- Conditions
- Glioblastoma
- Keywords
- Immunotherapy, Radiation/Temozolomide, Antitumor Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 2021 (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.
TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the preclinical data along with existing in vivo studies by others provides the rationale for therapeutic targeting of CD38 in GBM and its microenvironment. Daratumumab is commercially available, is safe and well tolerated when combined with alkylating chemotherapy, radiation therapy and has attained therapeutic CSF levels. Thus, the addition of Daratumumab to the frontline treatment regimen of GBM can potentially have a significant clinical benefit. Approximately 16 subjects will be enrolled in this trial. Up to 6 will be enrolled in the phase I part and 10 to 13 in the phase II part to come up with a total of 16 patients with 2 phases combined.
Detailed description
Glioblastoma (GBM) is an aggressive brain cancer. Current therapeutic strategies include maximal safe surgical resection followed by course of Temozolomide (TMZ) and radiation therapy (RT). Despite trimodality treatment, recurrence remains inevitable. Our study will use Daratumumab, an anti-CD38 monoclonal antibody, in combination with TMZ and RT in newly diagnosed GBM patients. There is pre-clinical evidence suggesting Daratumumab is cytotoxic to GBM in a multimodal fashion, its safe when combined with chemotherapy \& radiation therapy as well as has the potential to cross blood brain barrier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daratumumab | Experimental | Drug: DaratumumabDaratumumab, IV, 16 mg/KG - 1 dose prior to surgery or biopsy; Weeks 1 - 8 = 1 dose weekly; Weeks 9 - 24 = 1 dose every other week; Weeks 25 onward (determined by disease progression) = 1 dose every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects must have high radiological likelihood of GBM with plan for resection/biopsy for histologically confirmed GBM
- ECOG Performance status ≤ 2
- The effects of Daratumumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Key exclusion criteria (15 listed)
- Patients who received prior treatment for GBM.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Daratumumab and TMZ.
- BCG (Intravesical), Deferiprone, and Dipyrone are risk X category and should be avoided when Daratumumab is used. Chloramphenicol (Ophthalmic), promazine and Clozapine are in the risk category C and myelosuppression signs should be monitored when used in combination with Daratumumab.
- Avoid category Risk X drugs such as BCG (Intravesical), Deferiprone, Dipyrone, Natalizumab, Tacrolimus (Topical), Vaccines (Live) and Pimecrolimus concurrently with TMZ. Consider therapy modifications of category D drugs such as Baricitinib, Echinacea, Fingolimod, Leflunomide, Lenograstim, Lipegfilgrastim, Nivolumab, Palifermin, Roflumilast, Tofacitinib, Vaccines (Inactivated when used with TMZ. Monitor therapy for category risk C drugs such as Chloramphenicol (Ophthalmic), CloZAPine, Coccidioides immitis Skin Test, Denosumab, Ocrelizumab, Pidotimod, Promazine, Sipuleucel-T, Trastuzumab, and Valproate Products.
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 |
|---|---|---|
| DaratumumabAlso: DarzalexDaratumumab will be administered by IV infusion to subjects in combination with current therapeutic strategies of surgical resection followed by a course of Temozolomide and radiation therapy. | Drug | Daratumumab |
Primary outcome
Dose Limiting Toxicity (DLT) rate of Daratumumab
Time frame: Up to 6 weeks
Rate of subjects that experience DLT. Subjects will be evaluated for DLTs after 6 doses of Daratumumab. If there is no DLT in the first 3 patients, the investigators will move forward to conduct the phase II clinical trial. If there is a DLT, another three patients will be enrolled. The study may be suspended with additional discussions in the data monitoring committee if there are ≥2 identified DLTs in the first 3 patients or ≥2 DLTs in the first 6 patients. The sample size justification is based on the standard 3+3 design.
Phase II - Median overall survival of newly diagnosed GBM patients
Time frame: Up to 12 months
Evaluate the median overall survival of newly diagnosed GBM patients. All patients in phase I part will be included in the efficacy analysis on overall survival (OS) in phase II part. If the 1-year survival rate of the study subjects is above 50% (median survival rate), it will be considered that the new intervention is promising.
7 secondary outcomes
Phase I - Median overall survival of newly diagnosed GBM patients
Time frame: Up to 6 weeks
Phase I - Evaluate the Progression-Free Survival (PFS)
Time frame: Up to 6 weeks
Phase I - Assess the treatment-emergent adverse events
Time frame: Up to 6 weeks
Phase I - Estimate the tumor response rate
Time frame: Up to 6 weeks
Phase II - Evaluate the Progression-Free Survival (PFS)
Time frame: Up to 12 months
Phase II - Assess the treatment-emergent adverse events
Time frame: Up to 12 months
Phase II - Estimate the tumor response rate
Time frame: Up to 12 months
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 28 Apr 2026.
- Derived from this study: PubMed 41946147Norouzi S, Aulakh S. CD38 overexpression drives glioblastoma progression via L1CAM/ICAM1/JAK-STAT-Driven tumor microenvironment rewiring. Transl Oncol. 2026 May;67:102758. doi: 10.1016/j.tranon.2026.102758. Epub 2026 Apr 6.
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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.
Sonikpreet Aulakh, MD principal investigator
WVU Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Daratumumab in people with Glioblastoma, run by West Virginia University at 1 site 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 19 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Dose Limiting Toxicity (DLT) rate of Daratumumab (time frame: Up to 6 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?
On the ClinicalTrials.gov record for NCT04922723, 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 28 Apr 2026.