Recurrent High-grade GliomaPhase 1Peds CHAMP1ONNCT07031765
Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma
A Phase 1 study testing exHSC, Nivolumab and Resection or biopsy in people with Recurrent High-grade Glioma and Grade III Astrocytoma, run by University of Florida at 1 site in United States.
Trial summary
This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is recurrent… Read more about this study
- Who is it for?
- Ages 4 to 26 years
- Conditions the study is for
- Recurrent High-grade Glioma, Grade III Astrocytoma, Oligodendroglioma
- What is being tested?
- exHSC, Nivolumab and Resection or biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to Dec 2032
- 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 4 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have a histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is recurrent, progressive or refractory following radiotherapy with or without chemotherapy. Patients must be candidates for standard of care surgical resection or biopsy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in two dimensions.
- Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 2 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study.
- Patients must have received their last dose of known myelosuppressive anticancer therapy greater than 21 days prior to enrollment.
- Patients must have received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.
- For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration must be discussed with and approved by the study chair.
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- Monoclonal antibody treatment and/or agents with prolonged half-lives: At least three half-lives must have elapsed prior to enrollment.
- Patients must have had their last fraction of:
- Craniospinal irradiation ≥ 3 months prior to enrollment.
- Other substantial bone marrow irradiation ≥6 weeks prior to enrollment
- Local palliative XRT ≥2 weeks
- ≥ 12 weeks since autologous bone marrow/stem cell transplant prior to enrollment
- Patients with any history of allogeneic transplant are not eligible
- Patient must be ≥ 4 but ≤ 26 years of age at the time of enrollment.
- Karnofsky ≥ 60% for > 16 years of age; Lansky ≥ 60% for children ≤ 16 years of age
- Participants who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Patients must have adequate organ and marrow function as defined below:
- Absolute neutrophil count >1000 cells/μL
- Platelets >75,000 cells/μL(unsupported, defined as no platelet transfusion within 7 days)
- Hemoglobin ≥8g/dl (may receive transfusions)
- Total bilirubin ≤1.5 times institutional upper limit of normal (ULN)
- ALT(SGPT) <3 x institutional upper limit of normal
- Albumin ≥2 g/dl
- Serum creatinine based on age/gender as noted in Table 1 Patients that do not meet the criteria below but have a 24hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 ml/min/1.73 m2 are eligible.
- INR or PT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Pulmonary function - Pulse oximetry > 93% on room air and no evidence of dyspnea at rest.
- Patient must be a candidate for surgical resection or biopsy at the time of enrollment. The goal of surgical resection is both cytoreduction and tumor debulking, or biopsy for diagnosis confirmation as part of standard of care.
- Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment. A baseline detailed neurological exam should clearly document the neurological status of the patient at the time of enrollment on the study.
- Patients must be on a stable or decreasing dose of corticosteroids for 7 days prior to enrollment. A maximum dexamethasone dose of 0.1 mg/kg/day is allowed (4 mg maximum), but preferably have been discontinued (inhaled or topical use of steroids is allowed).
- The effects of nivolumab on the developing human fetus are unknown. 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, for the duration of study participation, and for 5 months after completion of nivolumab administration. 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 5 months after completion of nivolumab administration.
- Female subjects of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Ability to understand and the willingness to sign a written informed consent document. Parents/Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- Patients with evidence of leptomeningeal, primary spinal cord, or multicentric disease.
- Patients who have not recovered to ≤ Grade 1 or baseline from adverse events due to prior anti-cancer therapy.
- Patients who are receiving any other investigational agents.
- Female subjects of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
- Prior treatment with an anti-PD-1, anti PD-L1 and anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
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- Patients who have had prior allogenic hematopoietic stem cell transplant.
- Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Patients with uncontrolled intercurrent illness or any other significant condition(s) (serious infections or significant psychiatric, cardiac, pulmonary, hepatic, or other organ dysfunction that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity, or would interfere with the study procedures or results.
- Patients who have had live vaccines within 30 days prior to the first dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Children's Hospital/Shands Hospital
Gainesville, Florida, 32608
About this study
Official title: Peds CHAMP1ON - Combinatorial Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade Phase 1 Trial for RecurreNt Pediatric High-Grade Glioma
This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is recurrent, progressive or refractory following radiotherapy with or without chemotherapy. Patients must be candidates for standard of care surgical resection or biopsy.
Read the detailed description
This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with recurrent high-grade glioma. One cycle will be 28 days in length with exHSCs + Nivolumab being administered on day 1 and Nivolumab alone being administered on day 15 of each cycle for a total of 10 cycles. Nivolumab may continue for a total two years of therapy, at the discretion of the treating team.
There are two arms: Arm 1 - Immediate maximal surgical resection or biopsy, untreated tumor. exHSCs and Nivolumab will be administered after maximal surgical resection. Arm 2 - exHSCs + Nivolumab will be administered prior to maximal surgical resection or biopsy. exHSCs + Nivolumab will be administered after surgery.
- Conditions
- Recurrent High-grade Glioma, Grade III Astrocytoma, Oligodendroglioma, Oligoastrocytoma, Ependymoma, Grade IV Astrocytoma
- Being tested
- exHSC, Nivolumab, Resection or biopsy
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma, Ependymoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exHSCBiological
Ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) at a targeted dose of 2.5 x 106 cells/kg (or maximal achievable dose, with a minimum deliverable dose of 1/10 target dose; max dose 1.0 x 108 total cells for patients ≥40kg).
NivolumabDrug
Nivolumab 3mg/kg once every 2 weeks, max dose 240mg. Nivolumab will be administered on day 1 and day 15 of each cycle for a total of 10 cycles. Nivolumab may continue for a total two years of therapy, at the discretion of the treating team.
Resection or biopsyProcedure or surgery
Patients must be candidates for standard of care surgical resection or biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant exHSCs + Nivolumab (starting after surgery/biopsy) (Arm 1) | Experimental | Immediate maximal surgical resection or biopsy, untreated tumor. exHSCs and Nivolumab will be administered after maximal surgical resection. Receives: Biological: exHSC; Drug: Nivolumab; Procedure: Resection or biopsy |
| Neoadjuvant exHSCs + Nivolumab (starting before surgery/biopsy) (Arm 2) | Experimental | exHSCs + Nivolumab will be administered prior to maximal surgical resection or biopsy. Receives: Biological: exHSC; Drug: Nivolumab; Procedure: Resection or biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of DLTs in treated participants
Rate of DLTs in participants treated with exHSCs + αPD-1. Cycle 1 Day 1 is the first day exHSCs + Nivo is given.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Rate of ability to manufacture a product that meets release specifications and deliver the first study treatment
Feasibility of delivering exHSCs + αPD-1. Cycle 1 Day 1 is the first day exHSCs + Nivo is given.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start25 Jul 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent High-grade GliomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- John Ligon, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031765
- Sponsor's protocol ID
- 20252524
- Other IDs
- OCR47280
- Acronym
- Peds CHAMP1ON
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peds CHAMP1ON - Combinatorial Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade Phase 1 Trial for RecurreNt Pediatric High-Grade Glioma
- ClinicalTrials.gov ID
- NCT07031765
- Acronym / sponsor ID
- Peds CHAMP1ON / 20252524
- Conditions
- Recurrent High-grade Glioma, Grade III Astrocytoma, Oligodendroglioma, Oligoastrocytoma, Ependymoma, Grade IV Astrocytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 22 Jun 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.
This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is recurrent, progressive or refractory following radiotherapy with or without chemotherapy. Patients must be candidates for standard of care surgical resection or biopsy.
Detailed description
This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with recurrent high-grade glioma. One cycle will be 28 days in length with exHSCs + Nivolumab being administered on day 1 and Nivolumab alone being administered on day 15 of each cycle for a total of 10 cycles. Nivolumab may continue for a total two years of therapy, at the discretion of the treating team.
There are two arms: Arm 1 - Immediate maximal surgical resection or biopsy, untreated tumor. exHSCs and Nivolumab will be administered after maximal surgical resection. Arm 2 - exHSCs + Nivolumab will be administered prior to maximal surgical resection or biopsy. exHSCs + Nivolumab will be administered after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant exHSCs + Nivolumab (starting after surgery/biopsy) (Arm 1) | Experimental | Biological: exHSC, Drug: Nivolumab, Procedure: Resection or biopsyImmediate maximal surgical resection or biopsy, untreated tumor. exHSCs and Nivolumab will be administered after maximal surgical resection. |
| Neoadjuvant exHSCs + Nivolumab (starting before surgery/biopsy) (Arm 2) | Experimental | Biological: exHSC, Drug: Nivolumab, Procedure: Resection or biopsyexHSCs + Nivolumab will be administered prior to maximal surgical resection or biopsy. |
Who may qualify
- Ages
- 4 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (33 listed)
- Patients must have a histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is recurrent, progressive or refractory following radiotherapy with or without chemotherapy. Patients must be candidates for standard of care surgical resection or biopsy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in two dimensions.
- Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 2 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study.
- Patients must have received their last dose of known myelosuppressive anticancer therapy greater than 21 days prior to enrollment.
- Patients must have received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.
Key exclusion criteria (10 listed)
- Patients with evidence of leptomeningeal, primary spinal cord, or multicentric disease.
- Patients who have not recovered to ≤ Grade 1 or baseline from adverse events due to prior anti-cancer therapy.
- Patients who are receiving any other investigational agents.
- Female subjects of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
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 |
|---|---|---|
| exHSCEx vivo expanded CD34+ hematopoietic stem cells (exHSCs) at a targeted dose of 2.5 x 106 cells/kg (or maximal achievable dose, with a minimum deliverable dose of 1/10 target dose; max dose 1.0 x 108 total cells for patients ≥40kg). | Biological | Adjuvant exHSCs + Nivolumab (starting after surgery/biopsy) (Arm 1), Neoadjuvant exHSCs + Nivolumab (starting before surgery/biopsy) (Arm 2) |
| NivolumabNivolumab 3mg/kg once every 2 weeks, max dose 240mg. Nivolumab will be administered on day 1 and day 15 of each cycle for a total of 10 cycles. Nivolumab may continue for a total two years of therapy, at the discretion of the treating team. | Drug | Adjuvant exHSCs + Nivolumab (starting after surgery/biopsy) (Arm 1), Neoadjuvant exHSCs + Nivolumab (starting before surgery/biopsy) (Arm 2) |
| Resection or biopsyPatients must be candidates for standard of care surgical resection or biopsy. | Procedure or surgery | Adjuvant exHSCs + Nivolumab (starting after surgery/biopsy) (Arm 1), Neoadjuvant exHSCs + Nivolumab (starting before surgery/biopsy) (Arm 2) |
Primary outcome
Rate of DLTs in treated participants
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Rate of DLTs in participants treated with exHSCs + αPD-1. Cycle 1 Day 1 is the first day exHSCs + Nivo is given.
Rate of ability to manufacture a product that meets release specifications and deliver the first study treatment
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Feasibility of delivering exHSCs + αPD-1. Cycle 1 Day 1 is the first day exHSCs + Nivo is given.
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
John Ligon, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exHSC, Nivolumab and Resection or biopsy in people with Recurrent High-grade Glioma and Grade III Astrocytoma, run by University of Florida 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 33 inclusion and 10 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 23 Sep 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 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?
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?
Rate of DLTs in treated participants (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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 23 Sep 2026.