EpendymomaPhase 1NCT05106296
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
A Phase 1 study testing Indoximod, Ibrutinib and Cyclophosphamide in people with Ependymoma and Medulloblastoma, run by Theodore S. Johnson at 1 site in United States.
Trial summary
Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Ependymoma, Medulloblastoma, Glioblastoma
- What is being tested?
- Indoximod, Ibrutinib and Cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 30 Sep 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 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis:
- Patients must have prior documented progressive or refractory disease with histologically proven initial diagnosis of ependymoma, medulloblastoma, glioblastoma, or another type of primary cancer of the central nervous system with no curative conventional therapy options available.
- Metastatic disease is acceptable.
- Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease.
- Patients must be able to swallow pills.
- Lansky or Karnofsky performance status score must be ≥ 50%.
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- Adequate renal function:
- Creatinine clearance (CLcr) > 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient.
- Adequate liver function:
- Alanine aminotransferase (ALT) ≤ 3-times upper limit of normal.
- Aspartate aminotransferase (AST) ≤ 3-times upper limit of normal.
- Total bilirubin ≤ 1.5-times upper limit of normal unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1000/mm3 (independent of growth factor support).
- Platelets ≥ 100,000/mm3 (independent of transfusion support).
- Hemoglobin ≥ 8 g/dL (independent of transfusion support).
- Seizure disorders must be well controlled on antiepileptic medication.
- Prior therapy:
- Patients previously treated with chemotherapy drugs included in this protocol are eligible for enrollment.
- At the time of Screening, patients must be at least 21 days from the administration of any investigational agent (other than indoximod) or prior cytotoxic therapy (including chemotherapy).
- At the time of Screening, patients must be at least 28 days from administration of antibody-based therapies (e.g., bevacizumab), tumor-directed vaccines, or cellular immune therapies (e.g., T cells, NK cells, etc.).
- At the time of Screening, patients must be at least 56 days from administration of tumor-directed therapies using infectious agents (e.g., viruses, bacteria, etc.).
- At the time of Screening, patients must be at least 90 days from any radiation or proton therapy (all modalities, including radiosurgery) that targeted all sites of known disease.
- There is no lock-out window for patients who were treated with focal radiation or focal proton therapy (all modalities, including radiosurgery) that did not target all disease sites, if at least one site of active tumor is expected to persist and/or grow.
- Concurrent anti-neoplastic therapy:
- No investigational or commercial agents, including intrathecal drugs, other than that described by this clinical study protocol (GCC2020) may be administered with the intent to treat the patient's malignancy while they remain enrolled on this study.
- Contraception, pregnancy, and breastfeeding:
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study. Men must agree to not donate sperm during and for 3 months after the study.
- Women who are pregnant or breastfeeding are ineligible for this study.
- Patients who become pregnant while participating in this study will have to stop Study Therapy.
- Patients, or their parent for patients less than 18 years of age, must sign an Informed Consent Document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
- .
Who cannot join
- Patients who are unable to swallow pills.
- Patients with known hypersensitivity to any drugs in the treatment plan.
- Patients with active autoimmune disease that requires systemic therapy.
- Allergies, allergic conditions, and reactive inflammatory conditions that are not autoimmune in nature would not exclude patients (e.g., eczema, asthma, etc.).
- Pregnant or breastfeeding women.
- Major surgery or a wound that has not fully healed within 4 weeks of Screening.
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- Known central nervous system lymphoma.
- Patients with active bleeding or history of thrombotic or hemorrhagic stroke, or intracranial hemorrhage, within 6 months prior to Screening; with the exception of retained blood products from recent prior uncomplicated surgery (e.g., tumor biopsy, debulking, or resection; VP shunt placement, etc.).
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon).
- Requires chronic treatment with strong CYP3A inhibitor drugs.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- Patients with baseline QTc interval of more than 470 msec at the time of Screening, and patients with congenital long QT syndrome.
- Vaccinated with live, attenuated vaccines within 4 weeks of Screening.
- Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib, indoximod, or chemotherapy, or put the study outcomes at undue risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Augusta University, Georgia Cancer Center
Augusta, Georgia, 30912
Theodore S Johnson, MD, PhD, 706-721-4962, thjohnson@augusta.edu
Robin Dobbins, RN, 706-721-2154, rdobbins@augusta.edu
About this study
Official title: Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer
Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity.
The GCC2020 trial is a prospective open-label phase 1 trial to determine the best safe dose of the BTK-inhibitor ibrutinib to use in combination with previously studied chemo-immunotherapy regimens comprised of the investigational IDO-inhibitor indoximod plus oral palliative chemotherapy for participants, age 6 to 25 years, with relapsed or refractory primary brain cancer. Those previously treated with indoximod-based therapy may be eligible, including prior treatment via the phase 2 indoximod study (GCC1949, NCT04049669), the now closed phase 1 study (NLG2105, NCT02502708), or any expanded access (compassionate use) protocols. Ibrutinib will be combined with either indoximod plus oral cyclophosphamide and etoposide (Regimen A) or indoximod plus oral temozolomide (Regimen B). No cross-over between these two regimens will be allowed. Dose-escalation cohorts will determine the best safe dose of ibrutinib for each of these regimens. This will be followed by expansion cohorts, using ibrutinib at the best safe dose for each regimen, to allow assessment of preliminary evidence of efficacy.
- Conditions
- Ependymoma, Medulloblastoma, Glioblastoma, Primary Brain Tumor
- Being tested
- Indoximod, Ibrutinib, Cyclophosphamide, Etoposide, Temozolomide
- Keywords
- IDO, indoleamine 2,3-dioxygenase, indoximod, BTK, Bruton's Tyrosine Kinase, ibrutinib, immunotherapy, pediatric, childhood, brain tumor, brain cancer, glioblastoma, medulloblastoma, ependymoma, PNET, cyclophosphamide, etoposide, immune, central nervous system, CNS
- Medical subject headings
- Ependymoma, Medulloblastoma, Glioblastoma, Brain Neoplasms, Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndoximodDrug
Indoximod will be taken by mouth twice daily, throughout each treatment cycle.
IbrutinibDrug
For Regimen A, Ibrutinib will be taken by mouth once daily, on days 1-21 of each treatment cycle.
CyclophosphamideDrug
Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
EtoposideDrug
Etoposide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
IbrutinibDrug
For Regimen B, Ibrutinib will be taken by mouth once daily, on days 1-14 of each treatment cycle.
TemozolomideDrug
Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | Patients will be treated with ibrutinib plus indoximod, cyclophosphamide, and etoposide. Cycles are a minimum of 28 days. Receives: Drug: Indoximod; Drug: Ibrutinib; Drug: Cyclophosphamide; Drug: Etoposide |
| Regimen B | Experimental | Patients will be treated with ibrutinib plus indoximod and temozolomide. Cycles are a minimum of 28 days. Receives: Drug: Indoximod; Drug: Ibrutinib; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of regimen-limiting toxicity (RLT) for Regimen A
To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen A)
Measured: First 90 days of treatment
Objective Response Rate (ORR) for Regimen A
Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria
Measured: Up to 5 years
Incidence of regimen-limiting toxicity (RLT) for Regimen B
To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen B)
Measured: First 90 days of treatment
Objective Response Rate (ORR) for Regimen B
Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria
Measured: Up to 5 years
Secondary outcomes (8)
Adverse events (AEs)
To assess frequency, severity, and recoverability of AEs for the treatment regimen
Measured: Up to 19 months
Frequency of cycle delays for toxicity
To assess whether the immunotherapy contributes to delays in starting subsequent cycles of the chemotherapy drugs
Measured: Up to 18 months
Frequency of dose-reductions of the chemotherapy regimen
To assess whether the immunotherapy contributes to reductions in the doses of the chemotherapy drugs
Measured: Up to 18 months
Complete Response Rate (CRR)
Defined as the proportion of patients with a best objective response of CR using iRANO criteria
Measured: Up to 5 years
Partial Response Rate (PRR)
Defined as the proportion of patients with a best objective response of PR using iRANO criteria
Measured: Up to 5 years
Modified Objective Response Rate (mORR)
Defined as the proportion of patients with best objective response of complete response (CR), partial response (PR), or stable disease (SD, on at least 2 sequential study-timed MRIs) using iRANO criteria
Measured: Up to 5 years
iRANO-PFS
Time of Progression-Free Survival (PFS), defined as time from study entry to progression using iRANO criteria
Measured: Up to 5 years
Overall Survival (OS)
Time from study entry to death
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start8 Feb 2022
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpendymomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theodore S. Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University, CureSearch, Rally Foundation for Childhood Cancer Research
- Responsible party
- Sponsor-investigator, Theodore S. Johnson, Augusta University
- Investigators
- Theodore S. Johnson, MD, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106296
- Sponsor's protocol ID
- GCC2020
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johnson TS, MacDonald TJ, Pacholczyk R, Aguilera D, Al-Basheer A, Bajaj M, Bandopadhayay P, Berrong Z, Bouffet E, Castellino RC, Dorris K, Eaton BR, Esiashvili N, Fangusaro JR, Foreman N, Fridlyand D, Giller C, Heger IM, Huang C, Kadom N, Kennedy EP, Manoharan N, Martin W, McDonough C, Parker RS, Ramaswamy V, Ring E, Rojiani A, Sadek RF, Satpathy S, Schniederjan M, Smith A, Smith C, Thomas BE, Vaizer R, Yeo KK, Bhasin MK, Munn DH. Indoximod-based chemo-immunotherapy for pediatric brain tumors: A first-in-children phase I trial. Neuro Oncol. 2024 Feb 2;26(2):348-361. doi: 10.1093/neuonc/noad174.
PubMed 37715730Sharma MD, Pacholczyk R, Shi H, Berrong ZJ, Zakharia Y, Greco A, Chang CS, Eathiraj S, Kennedy E, Cash T, Bollag RJ, Kolhe R, Sadek R, McGaha TL, Rodriguez P, Mandula J, Blazar BR, Johnson TS, Munn DH. Inhibition of the BTK-IDO-mTOR axis promotes differentiation of monocyte-lineage dendritic cells and enhances anti-tumor T cell immunity. Immunity. 2021 Oct 12;54(10):2354-2371.e8. doi: 10.1016/j.immuni.2021.09.005. Epub 2021 Oct 5.
PubMed 34614413
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer
- ClinicalTrials.gov ID
- NCT05106296
- Acronym / sponsor ID
- GCC2020
- Conditions
- Ependymoma, Medulloblastoma, Glioblastoma, Primary Brain Tumor
- Keywords
- IDO, indoleamine 2,3-dioxygenase, indoximod, BTK, Bruton's Tyrosine Kinase, ibrutinib, immunotherapy, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Theodore S. JohnsonUniversity, hospital or other
- Collaborators
- Augusta University, CureSearch, Rally Foundation for Childhood Cancer Research
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Nov 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.
Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity.
The GCC2020 trial is a prospective open-label phase 1 trial to determine the best safe dose of the BTK-inhibitor ibrutinib to use in combination with previously studied chemo-immunotherapy regimens comprised of the investigational IDO-inhibitor indoximod plus oral palliative chemotherapy for participants, age 6 to 25 years, with relapsed or refractory primary brain cancer. Those previously treated with indoximod-based therapy may be eligible, including prior treatment via the phase 2 indoximod study (GCC1949, NCT04049669), the now closed phase 1 study (NLG2105, NCT02502708), or any expanded access (compassionate use) protocols. Ibrutinib will be combined with either indoximod plus oral cyclophosphamide and etoposide (Regimen A) or indoximod plus oral temozolomide (Regimen B). No cross-over between these two regimens will be allowed. Dose-escalation cohorts will determine the best safe dose of ibrutinib for each of these regimens. This will be followed by expansion cohorts, using ibrutinib at the best safe dose for each regimen, to allow assessment of preliminary evidence of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: Indoximod, Drug: Ibrutinib, Drug: Cyclophosphamide, Drug: EtoposidePatients will be treated with ibrutinib plus indoximod, cyclophosphamide, and etoposide. Cycles are a minimum of 28 days. |
| Regimen B | Experimental | Drug: Indoximod, Drug: Ibrutinib, Drug: TemozolomidePatients will be treated with ibrutinib plus indoximod and temozolomide. Cycles are a minimum of 28 days. |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (32 listed)
- Patients must have prior documented progressive or refractory disease with histologically proven initial diagnosis of ependymoma, medulloblastoma, glioblastoma, or another type of primary cancer of the central nervous system with no curative conventional therapy options available.
- Metastatic disease is acceptable.
- Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease.
- Patients must be able to swallow pills.
- Lansky or Karnofsky performance status score must be ≥ 50%.
Key exclusion criteria (15 listed)
- Patients who are unable to swallow pills.
- Patients with known hypersensitivity to any drugs in the treatment plan.
- Patients with active autoimmune disease that requires systemic therapy.
- Allergies, allergic conditions, and reactive inflammatory conditions that are not autoimmune in nature would not exclude patients (e.g., eczema, asthma, etc.).
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| IndoximodIndoximod will be taken by mouth twice daily, throughout each treatment cycle. | Drug | Regimen A, Regimen B |
| IbrutinibFor Regimen A, Ibrutinib will be taken by mouth once daily, on days 1-21 of each treatment cycle. | Drug | Regimen A |
| CyclophosphamideCyclophosphamide will be taken by mouth once daily, on days 1-21 of each treatment cycle. | Drug | Regimen A |
| EtoposideEtoposide will be taken by mouth once daily, on days 1-21 of each treatment cycle. | Drug | Regimen A |
| IbrutinibFor Regimen B, Ibrutinib will be taken by mouth once daily, on days 1-14 of each treatment cycle. | Drug | Regimen B |
| TemozolomideTemozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle. | Drug | Regimen B |
Primary outcome
Incidence of regimen-limiting toxicity (RLT) for Regimen A
Time frame: First 90 days of treatment
To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen A)
Objective Response Rate (ORR) for Regimen A
Time frame: Up to 5 years
Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria
Incidence of regimen-limiting toxicity (RLT) for Regimen B
Time frame: First 90 days of treatment
To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen B)
Objective Response Rate (ORR) for Regimen B
Time frame: Up to 5 years
Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria
8 secondary outcomes
Adverse events (AEs)
Time frame: Up to 19 months
Frequency of cycle delays for toxicity
Time frame: Up to 18 months
Frequency of dose-reductions of the chemotherapy regimen
Time frame: Up to 18 months
Complete Response Rate (CRR)
Time frame: Up to 5 years
Partial Response Rate (PRR)
Time frame: Up to 5 years
Modified Objective Response Rate (mORR)
Time frame: Up to 5 years
iRANO-PFS
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
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 9 Jan 2026.
- Background: PubMed 37715730Johnson TS, MacDonald TJ, Pacholczyk R, Aguilera D, Al-Basheer A, Bajaj M, Bandopadhayay P, Berrong Z, Bouffet E, Castellino RC, Dorris K, Eaton BR, Esiashvili N, Fangusaro JR, Foreman N, Fridlyand D, Giller C, Heger IM, Huang C, Kadom N, Kennedy EP, Manoharan N, Martin W, McDonough C, Parker RS, Ramaswamy V, Ring E, Rojiani A, Sadek RF, Satpathy S, Schniederjan M, Smith A, Smith C, Thomas BE, Vaizer R, Yeo KK, Bhasin MK, Munn DH. Indoximod-based chemo-immunotherapy for pediatric brain tumors: A first-in-children phase I trial. Neuro Oncol. 2024 Feb 2;26(2):348-361. doi: 10.1093/neuonc/noad174.
- Background: PubMed 34614413Sharma MD, Pacholczyk R, Shi H, Berrong ZJ, Zakharia Y, Greco A, Chang CS, Eathiraj S, Kennedy E, Cash T, Bollag RJ, Kolhe R, Sadek R, McGaha TL, Rodriguez P, Mandula J, Blazar BR, Johnson TS, Munn DH. Inhibition of the BTK-IDO-mTOR axis promotes differentiation of monocyte-lineage dendritic cells and enhances anti-tumor T cell immunity. Immunity. 2021 Oct 12;54(10):2354-2371.e8. doi: 10.1016/j.immuni.2021.09.005. Epub 2021 Oct 5.
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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.
Theodore S. Johnson, MD, PhD principal investigator
Augusta University
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 Indoximod, Ibrutinib and Cyclophosphamide in people with Ependymoma and Medulloblastoma, run by Theodore S. Johnson 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 32 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: looking for participants now, as of the sponsor's last update on 9 Jan 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?
Contact Theodore S. Johnson, MD, PhD (706-721-4962, thjohnson@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of regimen-limiting toxicity (RLT) for Regimen A (time frame: First 90 days of treatment). The study lists 4 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 NCT05106296, which also lists 2 linked publications.
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 9 Jan 2026.