Steroid Refractory Graft Versus Host DiseasePhase 1/2NCT07576699
CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
A Phase 1/2 study testing CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched) in people with Steroid Refractory Graft Versus Host Disease, run by Cellenkos, Inc..
Trial summary
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Steroid Refractory Graft Versus Host Disease
- What is being tested?
- CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Jun 2029
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Age ≥12 years old (first 3 subjects will be ≥ 18 years)
- 2. Grade 2-4 acute GVHD (aGVHD) at baseline
- 3. No other prior aGVHD treatment
- 4. Steroid Refractory
- Progressed after 3 days of treatment with 2 mg/kg methylprednisolone (MPE)
- No improvement after 7 days of treatment with 2 mg/kg MPE
Show all 12Show fewer
- Progressed to a new organ after treatment with 1 mg/kg MPE for skin or upper gastrointestinal (UGI) aGVHD
- Progressed from nadir during or after a steroid taper
- 5. Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test.
- 6. Agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
- 7. Willing and able to provide written informed consent.
- 8. Signed informed consent
Who cannot join
- 1. 30 days prior treatment with any other investigational agent after allogeneic HSCT.
- 2. Known HIV seropositivity.
- 3. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- 4. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and/or impair the activity of CK0802.
- 5. Subjects who are pregnant or breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
Read the detailed description
This clinical trial will be conducted in two parts where the first part of Phase 1b will determine the safety and tolerability of CK0802 in patients with steroid refractory GVHD and the second part of Phase 2a will examine the preliminary efficacy of CK0802 in patients with steroid refractory GVHD
- Being tested
- CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)
- Keywords
- gvhd, Tregs, graft vs. host disease, steroid refractory, steroid refractory GVHD, CK0802, T regulatory cells, CK0802 Tregs
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)Biological
Subjects will receive seven planned doses of CK0802 on study day +1, +3 (+/-1 day), +5 (+/-1 day), +7 (+/- 2 day), +14 (+/- 3 days), +21 (+/-3 days) and +28 (+/-3 days). A total of 7 doses will be administered.
If Day 29 assessment shows PR or MR, then 4 additional weekly infusion of CK0802 Tregs can be administered (study days: 35 (+/- 2 day), 42 (+/- 2 day), 49 (+/- 2 day), and 55(+/- 2 day)), for a total of 11 infusions
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | CK0802 Tregs will be administered intravenously at a fixed dose of 100 million Treg cells. Receives: Biological: CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b
Dose limiting toxicities of CK0802 in SR GVHD as assessed by the incidence and severity of AE and SAEs determined by the NCI-CTCAE Version 6.0.
Non-Hematologic: Any ≥ Grade 3 non-hematologic AE as per CTCAE v6.0 Hematologic: Any new or worsened Grade 4 neutropenia, thrombocytopenia, or anemia compared with baseline that persists for >7 days despite supportive care and is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause.
Death: Death within 28 days that is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause
Measured: Day +29
Phase 2a
Overall Response (OR) at day +29. Overall response (OR) will include complete response (CR) and partial response (PR). Response to be determined from the maximum acute GVHD stage and grade in each organ.
Complete Response (CR): Stage 0 in all organs (skin, liver, and GI tract) and no intervening additional therapy Partial Response (PR): Improvement of at least 1 stage in 1 or more organs without progression in other organs, and no intervening additional therapy Overall Response (OR): Includes both CR and PR Very Good PR (VGPR): Improvement by at least one stage in one or more organs and
- Skin: No rash, or bullae, and residual erythematous rash involving <25% of the body surface
- Liver: Total serum bilirubin concentration of <2 mg/dL or <25% of baseline at enrollment
- Gut: Tolerating food or enteral feeding, predominantly formed stools, no overt GI bleeding or abdominal cramping, no more than occasional nausea or vomiting
- No intervening additional therapy
Measured: D +29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for Steroid Refractory Graft Versus Host DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple doses of CK0802 will be administered intravenously over approximately a month
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellenkos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576699
- Sponsor's protocol ID
- CK0802-101-1
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared based on request and after proper de-identifiers to protect individual patient information is in place.
Publications
WALLACE AB. The exposure treatment of burns. Lancet. 1951 Mar 3;1(6653):501-4. doi: 10.1016/s0140-6736(51)91975-7. No abstract available.
PubMed 14805109Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
PubMed 2702835Levine JE. Prediction and Prognostication of Acute Graft-Versus-Host Disease by MAGIC Biomarkers. Am J Hematol. 2025 May;100 Suppl 3(Suppl 3):5-13. doi: 10.1002/ajh.27594.
PubMed 40123552Malard F, Huang XJ, Sim JPY. Treatment and unmet needs in steroid-refractory acute graft-versus-host disease. Leukemia. 2020 May;34(5):1229-1240. doi: 10.1038/s41375-020-0804-2. Epub 2020 Apr 3.
PubMed 32242050Mahat U, Przepiorka D, Fashoyin-Aje LA. Remestemcel-L-rknd for Steroid-Refractory Acute Graft-vs-Host Disease in Pediatric Patients. JAMA. 2025 Jul 1;334(1):81-82. doi: 10.1001/jama.2025.6179.
PubMed 40397429Shneider NA, Nesta AV, Rifai OM, Yasek J, Elyaman W, Aziz-Zaman S, Lyu MA, Levy SHS, Hoover BN, Vlad G, Huang M, Zeng K, Sadeghi T, Reddy A, Flowers CR, Parmar S. Clinical Safety and Preliminary Efficacy of Regulatory T Cells for ALS. NEJM Evid. 2025 May;4(5):EVIDoa2400249. doi: 10.1056/EVIDoa2400249. Epub 2025 Apr 22.
PubMed 40261116Gladstone DE, Kim BS, Mooney K, Karaba AH, D'Alessio FR. Regulatory T Cells for Treating Patients With COVID-19 and Acute Respiratory Distress Syndrome: Two Case Reports. Ann Intern Med. 2020 Nov 17;173(10):852-853. doi: 10.7326/L20-0681. Epub 2020 Jul 6. No abstract available.
PubMed 32628535Kadia TM, Huang M, Pemmaraju N, Abbas HA, Ly C, Masarova L, Yilmaz M, Lyu MA, Zeng K, Sadeghi T, Cook R, DiNardo CD, Daver N, Issa GC, Jabbour E, Borthakur G, Jain N, Garcia-Manero G, Parmar S, Flowers C, Kantarjian H, Verstovsek S. Phase 1 Study of CK0801 in Treatment of Bone Marrow Failure Syndromes. NEJM Evid. 2024 Jun;3(6):EVIDoa2300362. doi: 10.1056/EVIDoa2300362. Epub 2024 May 28.
PubMed 38804782Gladstone DE, D'Alessio F, Howard C, Lyu MA, Mock JR, Gibbs KW, Abrams D, Huang M, Zeng K, Herlihy JP, Castillo ST, Bassett R, Sadeghi T, Parmar S, Flowers CR, Mukherjee S, Schoenfeld D, Thall PF, Slutsky AS. Randomized, double-blinded, placebo-controlled trial of allogeneic cord blood T-regulatory cells for treatment of COVID-19 ARDS. Blood Adv. 2023 Jul 11;7(13):3075-3079. doi: 10.1182/bloodadvances.2022009619. No abstract available.
PubMed 36961352Fajgenbaum DC, June CH. Cytokine Storm. N Engl J Med. 2020 Dec 3;383(23):2255-2273. doi: 10.1056/NEJMra2026131. No abstract available.
PubMed 33264547Chen R, Lan Z, Ye J, Pang L, Liu Y, Wu W, Qin X, Guo Y, Zhang P. Cytokine Storm: The Primary Determinant for the Pathophysiological Evolution of COVID-19 Deterioration. Front Immunol. 2021 Apr 28;12:589095. doi: 10.3389/fimmu.2021.589095. eCollection 2021.
PubMed 33995341Wang Y, Perlman S. COVID-19: Inflammatory Profile. Annu Rev Med. 2022 Jan 27;73:65-80. doi: 10.1146/annurev-med-042220-012417. Epub 2021 Aug 26.
PubMed 34437814Martelli MF, Di Ianni M, Ruggeri L, Falzetti F, Carotti A, Terenzi A, Pierini A, Massei MS, Amico L, Urbani E, Del Papa B, Zei T, Iacucci Ostini R, Cecchini D, Tognellini R, Reisner Y, Aversa F, Falini B, Velardi A. HLA-haploidentical transplantation with regulatory and conventional T-cell adoptive immunotherapy prevents acute leukemia relapse. Blood. 2014 Jul 24;124(4):638-44. doi: 10.1182/blood-2014-03-564401. Epub 2014 Jun 12.
PubMed 24923299Matsuoka K, Kim HT, McDonough S, Bascug G, Warshauer B, Koreth J, Cutler C, Ho VT, Alyea EP, Antin JH, Soiffer RJ, Ritz J. Altered regulatory T cell homeostasis in patients with CD4+ lymphopenia following allogeneic hematopoietic stem cell transplantation. J Clin Invest. 2010 May;120(5):1479-93. doi: 10.1172/JCI41072. Epub 2010 Apr 12.
PubMed 20389017Rezvani K, Mielke S, Ahmadzadeh M, Kilical Y, Savani BN, Zeilah J, Keyvanfar K, Montero A, Hensel N, Kurlander R, Barrett AJ. High donor FOXP3-positive regulatory T-cell (Treg) content is associated with a low risk of GVHD following HLA-matched allogeneic SCT. Blood. 2006 Aug 15;108(4):1291-7. doi: 10.1182/blood-2006-02-003996. Epub 2006 Apr 20.
PubMed 16627754
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
- ClinicalTrials.gov ID
- NCT07576699
- Acronym / sponsor ID
- CK0802-101-1
- Keywords
- gvhd, Tregs, graft vs. host disease, steroid refractory, steroid refractory GVHD, CK0802, T regulatory cells, CK0802 Tregs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cellenkos, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 May 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.
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
Detailed description
This clinical trial will be conducted in two parts where the first part of Phase 1b will determine the safety and tolerability of CK0802 in patients with steroid refractory GVHD and the second part of Phase 2a will examine the preliminary efficacy of CK0802 in patients with steroid refractory GVHD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple doses of CK0802 will be administered intravenously over approximately a month
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)CK0802 Tregs will be administered intravenously at a fixed dose of 100 million Treg cells. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Age ≥12 years old (first 3 subjects will be ≥ 18 years)
- 2. Grade 2-4 acute GVHD (aGVHD) at baseline
- 3. No other prior aGVHD treatment
- 4. Steroid Refractory
- Progressed after 3 days of treatment with 2 mg/kg methylprednisolone (MPE)
Key exclusion criteria (5 listed)
- 1. 30 days prior treatment with any other investigational agent after allogeneic HSCT.
- 2. Known HIV seropositivity.
- 3. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- 4. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and/or impair the activity of CK0802.
- 5. Subjects who are pregnant or breastfeeding.
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 |
|---|---|---|
| CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)Subjects will receive seven planned doses of CK0802 on study day +1, +3 (+/-1 day), +5 (+/-1 day), +7 (+/- 2 day), +14 (+/- 3 days), +21 (+/-3 days) and +28 (+/-3 days). A total of 7 doses will be administered. If Day 29 assessment shows PR or MR, then 4 additional weekly infusion of CK0802 Tregs can be administered (study days: 35 (+/- 2 day), 42 (+/- 2 day), 49 (+/- 2 day), and 55(+/- 2 day)), for a total of 11 infusions | Biological | Treatment Arm |
Primary outcome
Phase 1b
Time frame: Day +29
Dose limiting toxicities of CK0802 in SR GVHD as assessed by the incidence and severity of AE and SAEs determined by the NCI-CTCAE Version 6.0. Non-Hematologic: Any ≥ Grade 3 non-hematologic AE as per CTCAE v6.0 Hematologic: Any new or worsened Grade 4 neutropenia, thrombocytopenia, or anemia compared with baseline that persists for >7 days despite supportive care and is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause. Death: Death within 28 days that is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause
Phase 2a
Time frame: D +29
Overall Response (OR) at day +29. Overall response (OR) will include complete response (CR) and partial response (PR). Response to be determined from the maximum acute GVHD stage and grade in each organ. Complete Response (CR): Stage 0 in all organs (skin, liver, and GI tract) and no intervening additional therapy Partial Response (PR): Improvement of at least 1 stage in 1 or more organs without progression in other organs, and no intervening additional therapy Overall Response (OR): Includes both CR and PR Very Good PR (VGPR): Improvement by at least one stage in one or more organs and * Skin: No rash, or bullae, and residual erythematous rash involving <25% of the body surface * Liver: Total serum bilirubin concentration of <2 mg/dL or <25% of baseline at enrollment * Gut: Tolerating food or enteral feeding, predominantly formed stools, no overt GI bleeding or abdominal cramping, no more than occasional nausea or vomiting * No intervening additional therapy
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 21 Oct 2026.
- Background: PubMed 14805109WALLACE AB. The exposure treatment of burns. Lancet. 1951 Mar 3;1(6653):501-4. doi: 10.1016/s0140-6736(51)91975-7. No abstract available.
- Background: PubMed 2702835Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
- Background: PubMed 40123552Levine JE. Prediction and Prognostication of Acute Graft-Versus-Host Disease by MAGIC Biomarkers. Am J Hematol. 2025 May;100 Suppl 3(Suppl 3):5-13. doi: 10.1002/ajh.27594.
- Background: PubMed 32242050Malard F, Huang XJ, Sim JPY. Treatment and unmet needs in steroid-refractory acute graft-versus-host disease. Leukemia. 2020 May;34(5):1229-1240. doi: 10.1038/s41375-020-0804-2. Epub 2020 Apr 3.
- Background: PubMed 40397429Mahat U, Przepiorka D, Fashoyin-Aje LA. Remestemcel-L-rknd for Steroid-Refractory Acute Graft-vs-Host Disease in Pediatric Patients. JAMA. 2025 Jul 1;334(1):81-82. doi: 10.1001/jama.2025.6179.
- Background: PubMed 40261116Shneider NA, Nesta AV, Rifai OM, Yasek J, Elyaman W, Aziz-Zaman S, Lyu MA, Levy SHS, Hoover BN, Vlad G, Huang M, Zeng K, Sadeghi T, Reddy A, Flowers CR, Parmar S. Clinical Safety and Preliminary Efficacy of Regulatory T Cells for ALS. NEJM Evid. 2025 May;4(5):EVIDoa2400249. doi: 10.1056/EVIDoa2400249. Epub 2025 Apr 22.
- Background: PubMed 32628535Gladstone DE, Kim BS, Mooney K, Karaba AH, D'Alessio FR. Regulatory T Cells for Treating Patients With COVID-19 and Acute Respiratory Distress Syndrome: Two Case Reports. Ann Intern Med. 2020 Nov 17;173(10):852-853. doi: 10.7326/L20-0681. Epub 2020 Jul 6. No abstract available.
- Background: PubMed 38804782Kadia TM, Huang M, Pemmaraju N, Abbas HA, Ly C, Masarova L, Yilmaz M, Lyu MA, Zeng K, Sadeghi T, Cook R, DiNardo CD, Daver N, Issa GC, Jabbour E, Borthakur G, Jain N, Garcia-Manero G, Parmar S, Flowers C, Kantarjian H, Verstovsek S. Phase 1 Study of CK0801 in Treatment of Bone Marrow Failure Syndromes. NEJM Evid. 2024 Jun;3(6):EVIDoa2300362. doi: 10.1056/EVIDoa2300362. Epub 2024 May 28.
- Background: PubMed 36961352Gladstone DE, D'Alessio F, Howard C, Lyu MA, Mock JR, Gibbs KW, Abrams D, Huang M, Zeng K, Herlihy JP, Castillo ST, Bassett R, Sadeghi T, Parmar S, Flowers CR, Mukherjee S, Schoenfeld D, Thall PF, Slutsky AS. Randomized, double-blinded, placebo-controlled trial of allogeneic cord blood T-regulatory cells for treatment of COVID-19 ARDS. Blood Adv. 2023 Jul 11;7(13):3075-3079. doi: 10.1182/bloodadvances.2022009619. No abstract available.
- Background: PubMed 33264547Fajgenbaum DC, June CH. Cytokine Storm. N Engl J Med. 2020 Dec 3;383(23):2255-2273. doi: 10.1056/NEJMra2026131. No abstract available.
- Background: PubMed 33995341Chen R, Lan Z, Ye J, Pang L, Liu Y, Wu W, Qin X, Guo Y, Zhang P. Cytokine Storm: The Primary Determinant for the Pathophysiological Evolution of COVID-19 Deterioration. Front Immunol. 2021 Apr 28;12:589095. doi: 10.3389/fimmu.2021.589095. eCollection 2021.
- Background: PubMed 34437814Wang Y, Perlman S. COVID-19: Inflammatory Profile. Annu Rev Med. 2022 Jan 27;73:65-80. doi: 10.1146/annurev-med-042220-012417. Epub 2021 Aug 26.
- Individual participant dataSharing planned: Yes. IPD can be shared based on request and after proper de-identifiers to protect individual patient information is in place.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched) in people with Steroid Refractory Graft Versus Host Disease, run by Cellenkos, Inc..
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 5 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Clinical Trial Specialist (8002178247, contact@cellenkosinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b (time frame: Day +29). 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 NCT07576699, which also lists 66 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 21 Oct 2026.