CancerPhase 1NCT07919509
A Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures
A Phase 1 study testing Panitumumab-IRDye800 in people with Cancer and Chemotherapy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a pilot project to determine the safety and feasibility of using panitumumab-IRDye800 to detect cancerous tissue compared to normal surrounding tissue in participants with ovarian cancer undergoing surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Chemotherapy, Squamous Cell Carcinoma (SCC)
- What is being tested?
- Panitumumab-IRDye800
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed diagnosis of ovarian cancer.
- Diagnosis of any stage.
- Diagnosis of any histology.
- Planning to undergo surgical resection via any modality (i.e., open, laparoscopic, robotic) with primary cytoreduction or interval debulking following neoadjuvant chemotherapy.
- Age ≥ 18 years
- ECOG 1
Show all 12Show fewer
- Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9 gm/dL
- Absolute Neutrophil Count ≥ 1500
- White Blood Cell count > 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
Who cannot join
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
- History of infusion reactions to any monoclonal antibody therapies
- Pregnant or breast-feeding
- Evidence of QT prolongation on pretreatment EKG (greater than 440 ms in males or greater than 450 ms in females)
- Magnesium or potassium lower than the normal institutional values
Show all 9Show fewer
- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- TSH > 13 micro International Units/mL
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
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Michelle Osoinak, BSN, RN, CNOR, 205-539-2903, mosoinak@uabmc.edu
Teresa Boitano, MD
About this study
Official title: Pilot Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures
This is a pilot project to determine the safety and feasibility of using panitumumab-IRDye800 to detect cancerous tissue compared to normal surrounding tissue in participants with ovarian cancer undergoing surgical resection. This study is an extension of the work previously done using this agent in patients with squamous cell carcinoma (SCC) of the head and neck, exploring its utility in a different cancer type.
Read the detailed description
The study is an open label, single site, Phase I study to determine the safety and feasibility of using conjugated panitumumab-IRDye800 in patients with ovarian cancer undergoing surgical resection. Tumor to background ratios (TBRs) will be determined by comparing fluorescence intensity of tumor tissue to grossly normal tissue in the field. The presence of tumor tissue and fluorescence will be confirmed by histopathologic analysis.
Panitumumab-IRDye800CW has a toxicity and pharmacodynamic profile that matches the parent compound. In this study, patients will receive a 50mg flat dose of panitumumab-IRdye800 without a loading dose of panitumumab alone, which was found in the Phase I study of patient with head and neck cancer to be the safest and most cost-effective dose in a dose-range escalation study with high sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) for fluorescence detection of tumor compared to normal background tissue. This infusion will occur 24-72 hours prior to planned surgery.
- Conditions
- Cancer, Chemotherapy, Squamous Cell Carcinoma (SCC)
- Being tested
- Panitumumab-IRDye800
- Keywords
- Cancer, Chemotherapy, squamous cell carcinoma (SCC)
- Medical subject headings
- Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab-IRDye800Drug
Single IV systemic infusion of panitumumab-IRDye800 and NIR imaging of cancer during and after surgical resection.
Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. All appropriate labs, tests, and safety monitoring will occur as outlined in Section 8.1. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring surgical resection of ovarian cancer | Experimental | Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity. Receives: Drug: Panitumumab-IRDye800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) defined as any grade 2 or greater toxicity that is considered definitely related to the study drug, considered clinically significant by the Principal Investigator, and occurs within 15 days of receiving treatment.
Measured: up to 15 days after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Boitano, University of Alabama at Birmingham
- Investigators
- Teresa Boitano, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919509
- Sponsor's protocol ID
- STUDY00000341
- Other IDs
- UAB
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agnes RS, Broome AM, Wang J, Verma A, Lavik K, Basilion JP. An optical probe for noninvasive molecular imaging of orthotopic brain tumors overexpressing epidermal growth factor receptor. Mol Cancer Ther. 2012 Oct;11(10):2202-11. doi: 10.1158/1535-7163.MCT-12-0211. Epub 2012 Jul 17.
PubMed 22807580Agusti N, Barajas K, Rauh-Hain JA. Minimally invasive surgery in advanced and recurrent ovarian cancer: current evidence and future directions. Curr Opin Oncol. 2025 Sep 1;37(5):478-486. doi: 10.1097/CCO.0000000000001162. Epub 2025 Jun 5.
PubMed 40511607Andrades P, Rosenthal EL, Carroll WR, Baranano CF, Peters GE. Zygomatic-maxillary buttress reconstruction of midface defects with the osteocutaneous radial forearm free flap. Head Neck. 2008 Oct;30(10):1295-302. doi: 10.1002/hed.20874.
PubMed 18642322Bailey L, Stone LD, Gonzalez ML, Thomas CM, Jeyarajan H, Warram JM, Panuganti B. Panitumumab-IRDye800 Improves Laryngeal Tumor Mapping During Transoral Laser Microsurgery. Laryngoscope. 2024 Apr;134(4):1837-1841. doi: 10.1002/lary.31078. Epub 2023 Oct 20.
PubMed 37860983Barnes TG, Volpi D, Cunningham C, Vojnovic B, Hompes R. Improved urethral fluorescence during low rectal surgery: a new dye and a new method. Tech Coloproctol. 2018 Feb;22(2):115-119. doi: 10.1007/s10151-018-1757-6. Epub 2018 Feb 19.
PubMed 29460054Chiu CH, Chao YK, Liu YH, Wen CT, Chen WH, Wu CY, Hsieh MJ, Wu YC, Liu HP. Clinical use of near-infrared fluorescence imaging with indocyanine green in thoracic surgery: a literature review. J Thorac Dis. 2016 Oct;8(Suppl 9):S744-S748. doi: 10.21037/jtd.2016.09.70.
PubMed 28066678Cohen R, Stammes MA, de Roos IH, Stigter-van Walsum M, Visser GW, van Dongen GA. Inert coupling of IRDye800CW to monoclonal antibodies for clinical optical imaging of tumor targets. EJNMMI Res. 2011 Dec 1;1(1):31. doi: 10.1186/2191-219X-1-31.
PubMed 22214225Day KE, Beck LN, Deep NL, Kovar J, Zinn KR, Rosenthal EL. Fluorescently labeled therapeutic antibodies for detection of microscopic melanoma. Laryngoscope. 2013 Nov;123(11):2681-9. doi: 10.1002/lary.24102. Epub 2013 Apr 24.
PubMed 23616260Day KE, Beck LN, Heath CH, Huang CC, Zinn KR, Rosenthal EL. Identification of the optimal therapeutic antibody for fluorescent imaging of cutaneous squamous cell carcinoma. Cancer Biol Ther. 2013 Mar;14(3):271-7. doi: 10.4161/cbt.23300. Epub 2013 Jan 8.
PubMed 23298904Day KE, Sweeny L, Kulbersh B, Zinn KR, Rosenthal EL. Preclinical comparison of near-infrared-labeled cetuximab and panitumumab for optical imaging of head and neck squamous cell carcinoma. Mol Imaging Biol. 2013 Dec;15(6):722-9. doi: 10.1007/s11307-013-0652-9.
PubMed 23715932de Boer E, Warram JM, Tucker MD, Hartman YE, Moore LS, de Jong JS, Chung TK, Korb ML, Zinn KR, van Dam GM, Rosenthal EL, Brandwein-Gensler MS. In Vivo Fluorescence Immunohistochemistry: Localization of Fluorescently Labeled Cetuximab in Squamous Cell Carcinomas. Sci Rep. 2015 Jun 29;5:10169. doi: 10.1038/srep10169.
PubMed 26120042de Wit JG, Vonk J, Voskuil FJ, de Visscher SAHJ, Schepman KP, Hooghiemstra WTR, Linssen MD, Elias SG, Halmos GB, Plaat BEC, Doff JJ, Rosenthal EL, Robinson D, van der Vegt B, Nagengast WB, van Dam GM, Witjes MJH. EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial. Nat Commun. 2023 Aug 16;14(1):4952. doi: 10.1038/s41467-023-40324-8.
PubMed 37587149DiLoreto DA Jr, Das T, del Cerro C, Cox C, del Cerro M. Fluorescein as a marker for subretinal transplantation of human fetal neural retina. Curr Eye Res. 1997 Nov;16(11):1159-65. doi: 10.1076/ceyr.16.11.1159.5100.
PubMed 9395777DSouza AV, Lin H, Henderson ER, Samkoe KS, Pogue BW. Review of fluorescence guided surgery systems: identification of key performance capabilities beyond indocyanine green imaging. J Biomed Opt. 2016 Aug 1;21(8):80901. doi: 10.1117/1.JBO.21.8.080901.
PubMed 27533438Fagotti A, Ferrandina MG, Vizzielli G, Pasciuto T, Fanfani F, Gallotta V, Margariti PA, Chiantera V, Costantini B, Gueli Alletti S, Cosentino F, Scambia G. Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850). Int J Gynecol Cancer. 2020 Nov;30(11):1657-1664. doi: 10.1136/ijgc-2020-001640. Epub 2020 Oct 7.
PubMed 33028623
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures
- ClinicalTrials.gov ID
- NCT07919509
- Acronym / sponsor ID
- STUDY00000341
- Conditions
- Cancer, Chemotherapy, Squamous Cell Carcinoma (SCC)
- Keywords
- Cancer, Chemotherapy, squamous cell carcinoma (SCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 5 Nov 2026 (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 pilot project to determine the safety and feasibility of using panitumumab-IRDye800 to detect cancerous tissue compared to normal surrounding tissue in participants with ovarian cancer undergoing surgical resection. This study is an extension of the work previously done using this agent in patients with squamous cell carcinoma (SCC) of the head and neck, exploring its utility in a different cancer type.
Detailed description
The study is an open label, single site, Phase I study to determine the safety and feasibility of using conjugated panitumumab-IRDye800 in patients with ovarian cancer undergoing surgical resection. Tumor to background ratios (TBRs) will be determined by comparing fluorescence intensity of tumor tissue to grossly normal tissue in the field. The presence of tumor tissue and fluorescence will be confirmed by histopathologic analysis.
Panitumumab-IRDye800CW has a toxicity and pharmacodynamic profile that matches the parent compound. In this study, patients will receive a 50mg flat dose of panitumumab-IRdye800 without a loading dose of panitumumab alone, which was found in the Phase I study of patient with head and neck cancer to be the safest and most cost-effective dose in a dose-range escalation study with high sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) for fluorescence detection of tumor compared to normal background tissue. This infusion will occur 24-72 hours prior to planned surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring surgical resection of ovarian cancer | Experimental | Drug: Panitumumab-IRDye800Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Biopsy-confirmed diagnosis of ovarian cancer.
- Diagnosis of any stage.
- Diagnosis of any histology.
- Planning to undergo surgical resection via any modality (i.e., open, laparoscopic, robotic) with primary cytoreduction or interval debulking following neoadjuvant chemotherapy.
- Age ≥ 18 years
Key exclusion criteria (9 listed)
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
- History of infusion reactions to any monoclonal antibody therapies
- Pregnant or breast-feeding
- Evidence of QT prolongation on pretreatment EKG (greater than 440 ms in males or greater than 450 ms in females)
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 |
|---|---|---|
| Panitumumab-IRDye800Single IV systemic infusion of panitumumab-IRDye800 and NIR imaging of cancer during and after surgical resection. Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. All appropriate labs, tests, and safety monitoring will occur as outlined in Section 8.1. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity. | Drug | Patients requiring surgical resection of ovarian cancer |
Primary outcome
Number of Dose limiting toxicity (DLT)
Time frame: up to 15 days after infusion
Dose limiting toxicity (DLT) defined as any grade 2 or greater toxicity that is considered definitely related to the study drug, considered clinically significant by the Principal Investigator, and occurs within 15 days of receiving treatment.
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 Nov 2026.
- Background: PubMed 22807580Agnes RS, Broome AM, Wang J, Verma A, Lavik K, Basilion JP. An optical probe for noninvasive molecular imaging of orthotopic brain tumors overexpressing epidermal growth factor receptor. Mol Cancer Ther. 2012 Oct;11(10):2202-11. doi: 10.1158/1535-7163.MCT-12-0211. Epub 2012 Jul 17.
- Background: PubMed 40511607Agusti N, Barajas K, Rauh-Hain JA. Minimally invasive surgery in advanced and recurrent ovarian cancer: current evidence and future directions. Curr Opin Oncol. 2025 Sep 1;37(5):478-486. doi: 10.1097/CCO.0000000000001162. Epub 2025 Jun 5.
- Background: PubMed 18642322Andrades P, Rosenthal EL, Carroll WR, Baranano CF, Peters GE. Zygomatic-maxillary buttress reconstruction of midface defects with the osteocutaneous radial forearm free flap. Head Neck. 2008 Oct;30(10):1295-302. doi: 10.1002/hed.20874.
- Background: PubMed 37860983Bailey L, Stone LD, Gonzalez ML, Thomas CM, Jeyarajan H, Warram JM, Panuganti B. Panitumumab-IRDye800 Improves Laryngeal Tumor Mapping During Transoral Laser Microsurgery. Laryngoscope. 2024 Apr;134(4):1837-1841. doi: 10.1002/lary.31078. Epub 2023 Oct 20.
- Background: PubMed 29460054Barnes TG, Volpi D, Cunningham C, Vojnovic B, Hompes R. Improved urethral fluorescence during low rectal surgery: a new dye and a new method. Tech Coloproctol. 2018 Feb;22(2):115-119. doi: 10.1007/s10151-018-1757-6. Epub 2018 Feb 19.
- Background: PubMed 28066678Chiu CH, Chao YK, Liu YH, Wen CT, Chen WH, Wu CY, Hsieh MJ, Wu YC, Liu HP. Clinical use of near-infrared fluorescence imaging with indocyanine green in thoracic surgery: a literature review. J Thorac Dis. 2016 Oct;8(Suppl 9):S744-S748. doi: 10.21037/jtd.2016.09.70.
- Background: PubMed 22214225Cohen R, Stammes MA, de Roos IH, Stigter-van Walsum M, Visser GW, van Dongen GA. Inert coupling of IRDye800CW to monoclonal antibodies for clinical optical imaging of tumor targets. EJNMMI Res. 2011 Dec 1;1(1):31. doi: 10.1186/2191-219X-1-31.
- Background: PubMed 23616260Day KE, Beck LN, Deep NL, Kovar J, Zinn KR, Rosenthal EL. Fluorescently labeled therapeutic antibodies for detection of microscopic melanoma. Laryngoscope. 2013 Nov;123(11):2681-9. doi: 10.1002/lary.24102. Epub 2013 Apr 24.
- Background: PubMed 23298904Day KE, Beck LN, Heath CH, Huang CC, Zinn KR, Rosenthal EL. Identification of the optimal therapeutic antibody for fluorescent imaging of cutaneous squamous cell carcinoma. Cancer Biol Ther. 2013 Mar;14(3):271-7. doi: 10.4161/cbt.23300. Epub 2013 Jan 8.
- Background: PubMed 23715932Day KE, Sweeny L, Kulbersh B, Zinn KR, Rosenthal EL. Preclinical comparison of near-infrared-labeled cetuximab and panitumumab for optical imaging of head and neck squamous cell carcinoma. Mol Imaging Biol. 2013 Dec;15(6):722-9. doi: 10.1007/s11307-013-0652-9.
- Background: PubMed 26120042de Boer E, Warram JM, Tucker MD, Hartman YE, Moore LS, de Jong JS, Chung TK, Korb ML, Zinn KR, van Dam GM, Rosenthal EL, Brandwein-Gensler MS. In Vivo Fluorescence Immunohistochemistry: Localization of Fluorescently Labeled Cetuximab in Squamous Cell Carcinomas. Sci Rep. 2015 Jun 29;5:10169. doi: 10.1038/srep10169.
- Background: PubMed 37587149de Wit JG, Vonk J, Voskuil FJ, de Visscher SAHJ, Schepman KP, Hooghiemstra WTR, Linssen MD, Elias SG, Halmos GB, Plaat BEC, Doff JJ, Rosenthal EL, Robinson D, van der Vegt B, Nagengast WB, van Dam GM, Witjes MJH. EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial. Nat Commun. 2023 Aug 16;14(1):4952. doi: 10.1038/s41467-023-40324-8.
- FDA. (2005). Panitumumab - Pharmacology/toxicology review and evaluation. (125147).Link provided by the sponsor.
- 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.
Teresa Boitano, MD principal investigator
University of Alabama at Birmingham
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 Panitumumab-IRDye800 in people with Cancer and Chemotherapy, run by University of Alabama at Birmingham 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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Nov 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 Michelle Osoinak, BSN, RN, CNOR (205-539-2903, mosoinak@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dose limiting toxicity (DLT) (time frame: up to 15 days after infusion). 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 NCT07919509, which also lists 60 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 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.