IrAEPhase 4NCT06178146
Thymosin Alpha-1 for irAE Secondary to ICIs
A Phase 4 study testing Thymosin Alpha1 and Immunosuppressant in people with IrAE, run by Jun Wang at 1 site in China.
Trial summary
Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IrAE
- What is being tested?
- Thymosin Alpha1 and Immunosuppressant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are males or females, aged 18 to 75 years;
- Subjects who are willing to sign the informed consent forms and receive follow-up visits;
- Subjects who are cytologically or histologically diagnosed with malignant solid tumors, including but not limited to genitourinary, gynecological, lung, liver, gastrointestinal tumors and melanoma;
- Subjects with malignant solid tumors who have developed irAEs within 6 months of immune checkpoint inhibitor therapy (CTLA-4, PD-1 and/or PD-L1). The immune checkpoint inhibitors can be used alone, or combined with chemotherapy drugs or other ICIs;
- Subjects with Grade 2 to 4 skin toxicity, enteritis, pneumonia and hepatitis secondary to ICIs according to CTCAE V5.0 and CSCO guidelines
- Subjects with sufficient bone marrow functions and meet the following requirements:
- Hemoglobin level ≥ 90 g/L (2) Neutrophil count ≥ 1.0×10^9/L (3) Lymphocyte count ≥ 0.5×10^9/L (4) Platelet count ≥75×10^9/L (5) PT, PTT, INR≤1.5 times ULN 7. Subjects with sufficient liver functions: Child-Pugh A and B; 8. Subjects with sufficient renal function: the estimated clearance rate calculated by the Cockroft-Gault formula is ≥40mL/min; 9. Suitable pregnant women who need to take effective contraceptive measures;
Who cannot join
- Subjects who have ever immune-related adverse events due to ICI treatment;
- Subjects who are diagnosed with immunodeficiency disease or are receiving systemic immunosuppressive therapy;
- Subjects who have skin damage, liver damage, lung damage, etc. caused by the progression of malignant tumors;
- Subjects who have the thromboembolic disease, biliary tract compression, perfusion injury, opportunistic infection, and liver injury caused by non-ICI drug reactions;
- Subjects who have abnormal laboratory indicators caused by hepatotropic viruses (such as HAV, HBC, HCV) and non-hepatotropic viruses (such as Epstein-Barr virus, cytomegalovirus, and herpes simplex virus);
- Subjects who are diagnosed with infectious colitis (e.g., caused by infections such as bacteria, Clostridium difficile, virus, fungus, parasite, etc.);
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- Subjects who suffer from autoimmune diseases, including but not limited to autoimmune hepatitis, primary cholangitis, primary sclerosing cholangitis, rheumatoid arthritis, vitiligo, psoriasis, Crohn's disease, type I diabetes, Grave's disease, etc.;
- Subjects who suffer from other respiratory diseases with clear etiology, including malignant pulmonary infiltration, active infection, alternative systemic pulmonary toxicity or radiation pneumonitis;
- Subjects with any other infectious diseases of grade 3 and above;
- Subjects who have received and used thymosin products or other immunomodulators before enrollment;
- Subjects who are allergic to thymosin products;
- Pregnant or breastfeeding women;
- Subjects who have any known bacterial, fungal or viral infections that may affect their safety or study compliance as deemed by the Investigator within 2 weeks before enrollment;
- Subjects who have any health conditions that may prevent them from participating in and complying with the procedures related to the study as deemed by the Investigator, including additional laboratory abnormalities or mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Shandong First Medical University
Jinan, Shandong, 250014
Jun Wang, Professor
About this study
Official title: A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events
Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).
- Conditions
- IrAE
- Being tested
- Thymosin Alpha1, Immunosuppressant
- Keywords
- immune-related adverse event, thymosin alpha 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin Alpha1Drug
Also called thymalfasin
Based on the conventional treatment, subcutaneous injection of Tα-1 (1.6 mg, qd) in Week 1; and in Week 2, subcutaneous injection of thymalfasin 1.6 mg, 3 times a week, followed by twice a week for 1 month since Week 3.
ImmunosuppressantDrug
Also called Prednisone, Cortisone, Mycophenolate Mofetil, Tacrolimus
Grade 2 irAEs: corticosteroid alone Grade 3 and above irAEs: corticosteroids combined with other immunosuppressants Steroid-refractory irAE: After 48-72 hours of systemic steroid therapy, the symptoms do not improve or worsen, and the second-line immunosuppressant therapy is adopted.
| Study group | Role | What they receive |
|---|---|---|
| Tα-1 group | Experimental | Subcutaneous injection with 1.6mg Thymosin alpha 1 in combination with the conventional therapy Receives: Drug: Thymosin Alpha1; Drug: Immunosuppressant |
| Control group | Active comparator | Conventional therapy includes corticosteroids and other immunosuppressants according to CSCO guidelines. Receives: Drug: Immunosuppressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms relieving rate
The proportion of immune-related adverse events reduced by at least 1 grade within 1 week after the first injection of thymalfasin.
Measured: within one week after the first injection of thymalfasin.
Secondary outcomes (3)
≤G1 rate
The proportion of total immune-related adverse events reduced to ≤ Grade 1 within 2, 4, 6 and 8 weeks after the first injection of thymalfasin;
Measured: up to 8 weeks
Median relieving time
The median time for an immune-related adverse event reduced to ≤ Grade 1
Measured: 8 weeks
The total dose of corticosteroid
The total dose of corticosteroids used during treatment, the duration and the proportion of intravenous infusion (IV)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Sep 2023
- Primary completionNov 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for IrAEStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Wang, Qianfoshan Hospital
- Investigators
- Jun Wang, Professor, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178146
- Sponsor's protocol ID
- ZAD-irAE
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serafino A, Pierimarchi P, Pica F, Andreola F, Gaziano R, Moroni N, Zonfrillo M, Sinibaldi-Vallebona P, Garaci E. Thymosin alpha1 as a stimulatory agent of innate cell-mediated immune response. Ann N Y Acad Sci. 2012 Oct;1270:13-20. doi: 10.1111/j.1749-6632.2012.06707.x.
PubMed 23050812Romani L, Oikonomou V, Moretti S, Iannitti RG, D'Adamo MC, Villella VR, Pariano M, Sforna L, Borghi M, Bellet MM, Fallarino F, Pallotta MT, Servillo G, Ferrari E, Puccetti P, Kroemer G, Pessia M, Maiuri L, Goldstein AL, Garaci E. Thymosin alpha1 represents a potential potent single-molecule-based therapy for cystic fibrosis. Nat Med. 2017 May;23(5):590-600. doi: 10.1038/nm.4305. Epub 2017 Apr 10.
PubMed 28394330Renga G, Bellet MM, Pariano M, Gargaro M, Stincardini C, D'Onofrio F, Mosci P, Brancorsini S, Bartoli A, Goldstein AL, Garaci E, Romani L, Costantini C. Thymosin alpha1 protects from CTLA-4 intestinal immunopathology. Life Sci Alliance. 2020 Aug 14;3(10):e202000662. doi: 10.26508/lsa.202000662. Print 2020 Oct.
PubMed 32817121Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
PubMed 23327199Liu J, Shen Y, Wen Z, Xu Q, Wu Z, Feng H, Li Z, Dong X, Huang S, Guo J, Zhang L, Chen Y, Li W, Zhu W, Du H, Liu Y, Wang T, Chen L, Teboul JL, Annane D, Chen D. Efficacy of Thymosin Alpha 1 in the Treatment of COVID-19: A Multicenter Cohort Study. Front Immunol. 2021 Aug 2;12:673693. doi: 10.3389/fimmu.2021.673693. eCollection 2021.
PubMed 34408744Liu F, Qiu B, Xi Y, Luo Y, Luo Q, Wu Y, Chen N, Zhou R, Guo J, Wu Q, Xiong M, Liu H. Efficacy of Thymosin alpha1 in Management of Radiation Pneumonitis in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043). Int J Radiat Oncol Biol Phys. 2022 Nov 1;114(3):433-443. doi: 10.1016/j.ijrobp.2022.07.009. Epub 2022 Jul 21.
PubMed 35870709
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events
- ClinicalTrials.gov ID
- NCT06178146
- Acronym / sponsor ID
- ZAD-irAE
- Conditions
- IrAE
- Keywords
- immune-related adverse event, thymosin alpha 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jun WangUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 20 Dec 2023 (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.
Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tα-1 group | Experimental | Drug: Thymosin Alpha1, Drug: ImmunosuppressantSubcutaneous injection with 1.6mg Thymosin alpha 1 in combination with the conventional therapy |
| Control group | Active comparator | Drug: ImmunosuppressantConventional therapy includes corticosteroids and other immunosuppressants according to CSCO guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are males or females, aged 18 to 75 years;
- Subjects who are willing to sign the informed consent forms and receive follow-up visits;
- Subjects who are cytologically or histologically diagnosed with malignant solid tumors, including but not limited to genitourinary, gynecological, lung, liver, gastrointestinal tumors and melanoma;
- Subjects with malignant solid tumors who have developed irAEs within 6 months of immune checkpoint inhibitor therapy (CTLA-4, PD-1 and/or PD-L1). The immune checkpoint inhibitors can be used alone, or combined with chemotherapy drugs or other ICIs;
- Subjects with Grade 2 to 4 skin toxicity, enteritis, pneumonia and hepatitis secondary to ICIs according to CTCAE V5.0 and CSCO guidelines
Key exclusion criteria (14 listed)
- Subjects who have ever immune-related adverse events due to ICI treatment;
- Subjects who are diagnosed with immunodeficiency disease or are receiving systemic immunosuppressive therapy;
- Subjects who have skin damage, liver damage, lung damage, etc. caused by the progression of malignant tumors;
- Subjects who have the thromboembolic disease, biliary tract compression, perfusion injury, opportunistic infection, and liver injury caused by non-ICI drug reactions;
- Subjects who have abnormal laboratory indicators caused by hepatotropic viruses (such as HAV, HBC, HCV) and non-hepatotropic viruses (such as Epstein-Barr virus, cytomegalovirus, and herpes simplex virus);
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 |
|---|---|---|
| Thymosin Alpha1Also: thymalfasinBased on the conventional treatment, subcutaneous injection of Tα-1 (1.6 mg, qd) in Week 1; and in Week 2, subcutaneous injection of thymalfasin 1.6 mg, 3 times a week, followed by twice a week for 1 month since Week 3. | Drug | Tα-1 group |
| ImmunosuppressantAlso: Prednisone, Cortisone, Mycophenolate Mofetil, TacrolimusGrade 2 irAEs: corticosteroid alone Grade 3 and above irAEs: corticosteroids combined with other immunosuppressants Steroid-refractory irAE: After 48-72 hours of systemic steroid therapy, the symptoms do not improve or worsen, and the second-line immunosuppressant therapy is adopted. | Drug | Control group, Tα-1 group |
Primary outcome
Symptoms relieving rate
Time frame: within one week after the first injection of thymalfasin.
The proportion of immune-related adverse events reduced by at least 1 grade within 1 week after the first injection of thymalfasin.
3 secondary outcomes
≤G1 rate
Time frame: up to 8 weeks
Median relieving time
Time frame: 8 weeks
The total dose of corticosteroid
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Results publication: PubMed 23050812Serafino A, Pierimarchi P, Pica F, Andreola F, Gaziano R, Moroni N, Zonfrillo M, Sinibaldi-Vallebona P, Garaci E. Thymosin alpha1 as a stimulatory agent of innate cell-mediated immune response. Ann N Y Acad Sci. 2012 Oct;1270:13-20. doi: 10.1111/j.1749-6632.2012.06707.x.
- Results publication: PubMed 28394330Romani L, Oikonomou V, Moretti S, Iannitti RG, D'Adamo MC, Villella VR, Pariano M, Sforna L, Borghi M, Bellet MM, Fallarino F, Pallotta MT, Servillo G, Ferrari E, Puccetti P, Kroemer G, Pessia M, Maiuri L, Goldstein AL, Garaci E. Thymosin alpha1 represents a potential potent single-molecule-based therapy for cystic fibrosis. Nat Med. 2017 May;23(5):590-600. doi: 10.1038/nm.4305. Epub 2017 Apr 10.
- Results publication: PubMed 32817121Renga G, Bellet MM, Pariano M, Gargaro M, Stincardini C, D'Onofrio F, Mosci P, Brancorsini S, Bartoli A, Goldstein AL, Garaci E, Romani L, Costantini C. Thymosin alpha1 protects from CTLA-4 intestinal immunopathology. Life Sci Alliance. 2020 Aug 14;3(10):e202000662. doi: 10.26508/lsa.202000662. Print 2020 Oct.
- Results publication: PubMed 23327199Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
- Results publication: PubMed 34408744Liu J, Shen Y, Wen Z, Xu Q, Wu Z, Feng H, Li Z, Dong X, Huang S, Guo J, Zhang L, Chen Y, Li W, Zhu W, Du H, Liu Y, Wang T, Chen L, Teboul JL, Annane D, Chen D. Efficacy of Thymosin Alpha 1 in the Treatment of COVID-19: A Multicenter Cohort Study. Front Immunol. 2021 Aug 2;12:673693. doi: 10.3389/fimmu.2021.673693. eCollection 2021.
- Results publication: PubMed 35870709Liu F, Qiu B, Xi Y, Luo Y, Luo Q, Wu Y, Chen N, Zhou R, Guo J, Wu Q, Xiong M, Liu H. Efficacy of Thymosin alpha1 in Management of Radiation Pneumonitis in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043). Int J Radiat Oncol Biol Phys. 2022 Nov 1;114(3):433-443. doi: 10.1016/j.ijrobp.2022.07.009. Epub 2022 Jul 21.
- 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.
Jun Wang, Professor principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thymosin Alpha1 and Immunosuppressant in people with IrAE, run by Jun Wang at 1 site in China.
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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Wang, Professor (0531-89269221, ggjun2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms relieving rate (time frame: within one week after the first injection of thymalfasin.). 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 NCT06178146, which also lists 6 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 20 Dec 2023; AzTrials last refreshed its copy on 26 Oct 2026.