GVHDPhase 1/2NCT06411184
Safety and Efficacy of Treg Cell in the Treatment of GVHD
A Phase 1/2 study testing Regulator T Cells in people with GVHD, run by Xuzhou Medical University.
Trial summary
This is a randomized, single-center phase 1/2a clinical trial without blinding. Regulatory T cells (Tregs) have shown potential in treating various immune-related diseases, including autoimmune disorders, transplant rejection, and inflammatory diseases. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- GVHD
- What is being tested?
- Regulator T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 May 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.
- Those with persistent manifestations of graft-versus-host disease (GVHD) and suitable for systemic treatment.
- Previously received at least 1 but not more than 5 lines of systemic treatment for GVHD.
- Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose >0.5mg/kg/day for four weeks, with ongoing GVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to >0.25mg/kg/day or an equivalent dose.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1.
- Anticipated survival of more than 12 months.
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- General criteria:
- Serum pregnancy test negative for women of childbearing age during the screening period.
- Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication.
Who cannot join
- Patients who have received experimental treatment for systemic GVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.
- Blood cancer relapse (according to the corresponding criteria for relapse of the primary blood cancer) or post-transplant lymphoproliferative disease at the time of screening.
- Laboratory tests:
- Absolute neutrophil count (ANC) <1.5×10^9/L (excluding GVHD as the cause).
- Platelet count <50×10^9/L (excluding GVHD as the cause).
- Alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) >3×ULN (excluding GVHD as the cause).
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- Total bilirubin (TBIL) >1.5×ULN (excluding GVHD as the cause).
- Creatinine clearance CrCl <60 mL/min (Cockcroft-Gault formula).
- General criteria:
- Pregnant or lactating women.
- History of serious illness or other evidence indicating a serious illness, or any other condition that the investigator believes may make the subject unsuitable for this study.
- History of severe cardiovascular disease [New York Heart Association (NYHA) functional class III or IV], including but not limited to ventricular arrhythmias requiring clinical intervention, uncontrolled hypertension (systolic blood pressure ≥160mmHg and/ or diastolic blood pressure ≥100mmHg); within 6 months prior to enrollment, there is unstable angina, acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of class III or above; at screening, NYHA functional class ≥II or left ventricular ejection fraction (LVEF) <50% on echocardiography.
- Unable to take oral medications, with severe (NCI CTCAE v5.0 ≥ grade 3) chronic gastrointestinal dysfunction, the presence of malabsorption syndrome, or any other condition affecting gastrointestinal absorption.
- History of clear neurological or psychiatric disorders (including epilepsy or dementia), currently suffering from psychiatric disorders, or judged by the investigator to be non-compliant and unsuitable for participation in the study.
- History of other severe (NCI CTCAE v5.0 ≥ grade 3) systemic diseases, deemed unsuitable for participation in the clinical trial by the investigator.
- Other circumstances in which the investigator deems it inappropriate to participate in this study.
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
Official title: Safety and Efficacy of Treg Cell in the Treatment of GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
This is a randomized, single-center phase 1/2a clinical trial without blinding. Regulatory T cells (Tregs) have shown potential in treating various immune-related diseases, including autoimmune disorders, transplant rejection, and inflammatory diseases. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of autologous Tregs in the treatment of GVHD.
Read the detailed description
This randomized, single-center phase 1/2a clinical trial, conducted without blinding, aims to explore the therapeutic promise of regulatory T cells (Tregs). Tregs are specialized immune cells that play a crucial role in modulating the body's immune response, thus offering a unique therapeutic avenue for immune-related conditions. They have already demonstrated significant potential in managing a spectrum of diseases, including autoimmune disorders such as multiple sclerosis and type 1 diabetes, inflammatory conditions like inflammatory bowel disease, and transplant rejection, which is commonly encountered in organ and stem cell transplants. The trial's primary focus is on graft-versus-host disease (GVHD), a severe complication that can occur after allogeneic hematopoietic stem cell transplantation (HSCT). GVHD emerges when the donated immune cells attack the recipient's tissues, leading to symptoms ranging from mild to life-threatening. Currently, GVHD treatment relies on broad immunosuppressive therapies, which often come with significant side effects and may not always be effective. By recruiting participants for this clinical trial, we aim to assess the safety and efficacy of Tregs in mitigating the immune system's attack on the recipient's body. Autologous Tregs offer a more targeted approach due to their ability to distinguish between harmful and beneficial immune responses, potentially reducing the need for broad immunosuppression. The trial's structure includes dose-escalation and dose-expansion phases to evaluate optimal dosages, assess any adverse reactions, and measure the therapeutic benefits in GVHD management. Through this systematic and thorough evaluation, the investigators hope to refine Treg therapy and establish a clear safety profile. Ultimately, this trial seeks to unlock the therapeutic potential of autologous Tregs, paving the way for future applications in a broader range of conditions.
- Conditions
- GVHD
- Being tested
- Regulator T Cells
- Keywords
- Regulatory T-Lymphocytes, GVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulator T CellsDrug
Also called Regulatory T-Lymphocytes
Autologous Regulatory T-Lymphocytes 1*10^6/kg, 2*10^6/kg, 4*10^6/kg and 8*10^6/kg, respectively until restrictive toxic reaction occurs
| Study group | Role | What they receive |
|---|---|---|
| Regulatory T-Lymphocytes | Experimental | Autologous Regulatory T-Lymphocytes 1*10^6/kg, 2*10^6/kg, 4*10^6/kg and 8*10^6/kg, respectively until restrictive toxic reaction occurs Receives: Drug: Regulator T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events assessed according to NCI-CTCAE v5.0
Measured: Baseline up to 60 days after taking Iguratimod]
Secondary outcomes (4)
complete response (CR)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
partial response (PR)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
stable disease (SD)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
progressed disease (PD)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Measured: Month 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHDStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Lin Xu，MD, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411184
- Sponsor's protocol ID
- XYFY2024-KL045-01
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Treg Cell in the Treatment of GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06411184
- Acronym / sponsor ID
- XYFY2024-KL045-01
- Conditions
- GVHD
- Keywords
- Regulatory T-Lymphocytes, GVHD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 May 2024 (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 randomized, single-center phase 1/2a clinical trial without blinding. Regulatory T cells (Tregs) have shown potential in treating various immune-related diseases, including autoimmune disorders, transplant rejection, and inflammatory diseases. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of autologous Tregs in the treatment of GVHD.
Detailed description
This randomized, single-center phase 1/2a clinical trial, conducted without blinding, aims to explore the therapeutic promise of regulatory T cells (Tregs). Tregs are specialized immune cells that play a crucial role in modulating the body's immune response, thus offering a unique therapeutic avenue for immune-related conditions. They have already demonstrated significant potential in managing a spectrum of diseases, including autoimmune disorders such as multiple sclerosis and type 1 diabetes, inflammatory conditions like inflammatory bowel disease, and transplant rejection, which is commonly encountered in organ and stem cell transplants. The trial's primary focus is on graft-versus-host disease (GVHD), a severe complication that can occur after allogeneic hematopoietic stem cell transplantation (HSCT). GVHD emerges when the donated immune cells attack the recipient's tissues, leading to symptoms ranging from mild to life-threatening. Currently, GVHD treatment relies on broad immunosuppressive therapies, which often come with significant side effects and may not always be effective. By recruiting participants for this clinical trial, we aim to assess the safety and efficacy of Tregs in mitigating the immune system's attack on the recipient's body. Autologous Tregs offer a more targeted approach due to their ability to distinguish between harmful and beneficial immune responses, potentially reducing the need for broad immunosuppression. The trial's structure includes dose-escalation and dose-expansion phases to evaluate optimal dosages, assess any adverse reactions, and measure the therapeutic benefits in GVHD management. Through this systematic and thorough evaluation, the investigators hope to refine Treg therapy and establish a clear safety profile. Ultimately, this trial seeks to unlock the therapeutic potential of autologous Tregs, paving the way for future applications in a broader range of conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regulatory T-Lymphocytes | Experimental | Drug: Regulator T CellsAutologous Regulatory T-Lymphocytes 1*10^6/kg, 2*10^6/kg, 4*10^6/kg and 8*10^6/kg, respectively until restrictive toxic reaction occurs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.
- Those with persistent manifestations of graft-versus-host disease (GVHD) and suitable for systemic treatment.
- Previously received at least 1 but not more than 5 lines of systemic treatment for GVHD.
- Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose >0.5mg/kg/day for four weeks, with ongoing GVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to >0.25mg/kg/day or an equivalent dose.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1.
Key exclusion criteria (16 listed)
- Patients who have received experimental treatment for systemic GVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.
- Blood cancer relapse (according to the corresponding criteria for relapse of the primary blood cancer) or post-transplant lymphoproliferative disease at the time of screening.
- Absolute neutrophil count (ANC) <1.5×10^9/L (excluding GVHD as the cause).
- Platelet count <50×10^9/L (excluding GVHD as the cause).
- Alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) >3×ULN (excluding GVHD as the cause).
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 |
|---|---|---|
| Regulator T CellsAlso: Regulatory T-LymphocytesAutologous Regulatory T-Lymphocytes 1*10^6/kg, 2*10^6/kg, 4*10^6/kg and 8*10^6/kg, respectively until restrictive toxic reaction occurs | Drug | Regulatory T-Lymphocytes |
Primary outcome
Adverse events
Time frame: Baseline up to 60 days after taking Iguratimod]
Adverse events assessed according to NCI-CTCAE v5.0
4 secondary outcomes
complete response (CR)
Time frame: Month 1, 2, 3 and 4
partial response (PR)
Time frame: Month 1, 2, 3 and 4
stable disease (SD)
Time frame: Month 1, 2, 3 and 4
progressed disease (PD)
Time frame: Month 1, 2, 3 and 4
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 13 May 2024.
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Graft vs Host Disease
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 Regulator T Cells in people with GVHD, run by Xuzhou Medical University.
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 9 inclusion and 16 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 13 May 2024. 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 Kailin Xu, MD.,PD. (15162166166, lihmd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Baseline up to 60 days after taking Iguratimod]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.