Type 1 Diabetes MellitusPhase 1NCT06708780
Immunotherapy with Autologous Tregs in T1DM
A Phase 1 study testing Ex vivo Expanded Human Autologous Regulatory T Cells and Routine Care in people with Type 1 Diabetes Mellitus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an… Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Ex vivo Expanded Human Autologous Regulatory T Cells and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2023to Dec 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 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
- Aged 8 to 65 years;
- At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
- Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.
Who cannot join
- The condition of diabetic ketoacidosis has not been controlled;
- Severe allergic constitution;
- Known or suspected tumor;
- Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
- Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
- Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
- Mental illness, alcohol or drug abuse, unable to cooperate with treatment;
- According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Dr. Lu, medical doctor, 0086-025-68182432, lujing@njglyy.com
Prof. Zhu, Medical doctor, 0086-025-68182432, zhudalong@nju.edu.cn
About this study
Official title: Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an autoimmune attack. Previouse studies have revealed the potential theraputic effects of autologous Treg transplantation in T1D. We have modified the preparation protocol for autologous Tregs. The purpose of this study is to assess the safety and effect of autologous Treg therapy in patients with T1D.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Ex vivo Expanded Human Autologous Regulatory T Cells, Routine Care
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo Expanded Human Autologous Regulatory T CellsBiological
Peripheral blood component donation is used to collect Treg cells for ex vivo expansion, with technical guidance provided by the Center for Biotechnology Drug Development at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
Routine CareOther
Routine care is provided to all participants according to clinical guidelines for T1DM.
| Study group | Role | What they receive |
|---|---|---|
| Treg Group | Experimental | Participants in this group are transplanted with expanded autologous Tregs in addition to routine therapy for T1DM. Receives: Biological: Ex vivo Expanded Human Autologous Regulatory T Cells; Other: Routine Care |
| Control Group | Other | Participants in this group receive only routine therapy for T1DM. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity.
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (1)
Therapeutic effects on diabetes-related outcomes
Therapeutic effects on diabetes-related outcomes 1 year after intervention include: 1) C-peptide response during mixed meal tolerance test, reported as the change from baseline in the fasting level, postprandial level and area under the curve; 2) Insulin Use; 3) Hemoglobin A1c.
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start12 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Responsible party
- Principal investigator, Zhu DaLong, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708780
- Sponsor's protocol ID
- 2021-427-TREG
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
- ClinicalTrials.gov ID
- NCT06708780
- Acronym / sponsor ID
- 2021-427-TREG
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Nov 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.
Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an autoimmune attack. Previouse studies have revealed the potential theraputic effects of autologous Treg transplantation in T1D. We have modified the preparation protocol for autologous Tregs. The purpose of this study is to assess the safety and effect of autologous Treg therapy in patients with T1D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treg Group | Experimental | Biological: Ex vivo Expanded Human Autologous Regulatory T Cells, Other: Routine CareParticipants in this group are transplanted with expanded autologous Tregs in addition to routine therapy for T1DM. |
| Control Group | Other | Other: Routine CareParticipants in this group receive only routine therapy for T1DM. |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
- Aged 8 to 65 years;
- At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
- Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.
Key exclusion criteria (8 listed)
- The condition of diabetic ketoacidosis has not been controlled;
- Severe allergic constitution;
- Known or suspected tumor;
- Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
- Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
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 |
|---|---|---|
| Ex vivo Expanded Human Autologous Regulatory T CellsPeripheral blood component donation is used to collect Treg cells for ex vivo expansion, with technical guidance provided by the Center for Biotechnology Drug Development at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. | Biological | Treg Group |
| Routine CareRoutine care is provided to all participants according to clinical guidelines for T1DM. | Other | Control Group, Treg Group |
Primary outcome
Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity.
Time frame: From enrollment to the end of treatment at 1 year
1 secondary outcome
Therapeutic effects on diabetes-related outcomes
Time frame: From enrollment to the end of treatment at 1 year
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 27 Nov 2024.
- 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.
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 Ex vivo Expanded Human Autologous Regulatory T Cells and Routine Care in people with Type 1 Diabetes Mellitus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 4 inclusion and 8 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 27 Nov 2024. 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 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 Dr. Lu, MD (0086-025-868182432, lujing@njglyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity. (time frame: From enrollment to the end of treatment at 1 year). 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 27 Nov 2024.