Diabetes type1Phase 1/2NCT03751007

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)

A Phase 1/2 study testing AG019 - Low Dose, Teplizumab and AG019 - High Dose in people with Diabetes type1, run by Precigen Actobio T1D, LLC at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D). Read more about this study

Who is it for?: Ages 12 to 40 years
Conditions the study is for: Diabetes type1
What is being tested?: AG019 - Low Dose, Teplizumab and AG019 - High Dose
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 18 sitesin 2 countries
Study dates: 24 Oct 2018to 13 Oct 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or non-pregnant, non-lactating females, 18 - 40 years of age (both inclusive) or 12-17 years of age (both inclusive)
Diagnosis of diabetes according to the American Diabetes Association (ADA) recommended criteria
Evidence of auto-antibodies to at least 1 β-cell autoantigen
Stimulated C-peptide measured during 4h Mixed Meal tolerance Test (MMTT) > 0.2 nmol/L
The first administration of AG019 should occur no later than 150 days post diagnosis of diabetes
Body weight ≥ 33kg
Written informed consent obtained and documented (participant, parent, guardian as applicable)

Who cannot join

Previous history of serious cytokine release syndrome to teplizumab or other humanized anti-CD3 monoclonal antibodies with no or minimal capacity to bind Fc receptors. (Participants enrolled in the second phase of the trial in either Combination Cohort 1 or Combination Cohort 2, only)
Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization
Participation in another investigational drug trial within 12 weeks prior to the first study drug intake and during participation in this study
History of recurrent infections, other autoimmune diseases, cardiac disease, malignancy, or any other (chronic) medical condition which, in the investigator's opinion, could compromise participant safety
Documented history of human immunodeficiency virus (HIV), Hepatitis Virus Type C (HCV), Hepatitis Virus Type B (HBV) infection
Evidence of active infection with Epstein-Barr Virus (EBV) or cytomegalovirus (CMV)

Show all 13Show fewer

Evidence of active or latent tuberculosis (TB)
Administration of anti-CD3 antibody in past year
Current therapy with any other anti-diabetic agents other than insulin (MDI, CSII or analogue). Current or planned therapy with experimental (i.e., unapproved) insulin. Patients on therapy for type 2 diabetes (e.g. metformin) should stop their therapy in order to be eligible for study participation.
Use of medications known to influence glucose tolerance
Daily use of non-steroidal anti-inflammatory agents
Compromised GI mucosal integrity or motility, not attributable to T1D (i.e., recent diarrhea, gluten sensitive enteropathy, inflammatory bowel disease, irritable bowel syndrome), or current use of medications known to influence GI motility
Positive result of SARS-Cov2 PCR test at screening or within 3 days before randomization

Trial locations and contacts

18 sites in 2 countries.

Country

City, postcode or hospital

18 sites in 2 countries

United States15 sites

University of Colorado
Aurora, Colorado, 80045
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749
Barry J Reiner, MD, LLC
Baltimore, Maryland, 21229
University of Alabama, Birmingham
Birmingham, Alabama, 35294
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411
Research Institute of Dallas
Dallas, Texas, 75231
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, 64108
University of Miami
Miami, Florida, 33136
University of Minnesota Health
Minneapolis, Minnesota, 55454
Yale Center for Clinical Investigation
New Haven, Connecticut, 06519
University of California, San Francisco
San Francisco, California, 94158
Benaroya Research Institute
Seattle, Washington, 98101
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, 57117
University of South Florida
Tampa, Florida, 33612
Coastal Metabolic Research Centre
Ventura, California, 93003

Other trials in United States

Belgium3 sites

UZ Brussel
Brussels, 1090
UZ Antwerpen
Edegem, 2650
UZ Leuven
Leuven, 3000

Other trials in Belgium

About this study

Official title: A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)

Read the detailed description

This Phase 1b/2a, multi-center study will be conducted in participants with clinical recent-onset type 1 diabetes (T1D).

The primary objective of this study is to assess the safety and tolerability of different doses of AG019 alone as well as AG019 in combination with teplizumab. The secondary objectives of this study are: to obtain pharmacodynamic (PD) data of AG019 alone as well as AG019 in combination with teplizumab; and to determine the potential presence of AG019 in systemic circulation (safety - systemic exposure) and the presence of L. lactis bacteria in fecal excretion (local exposure): Pharmacokinetic (PK) profile.

This study consists of 2 phases:

Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2 different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age).

Phase 2a: this randomized, double-blind part of the study will investigate the safety and tolerability of AG019, in combination with teplizumab, in 2 age groups (18-40 years of age and 12-17 years of age).

Conditions: Diabetes type1
Being tested: AG019 - Low Dose, Teplizumab, Placebo-AG019, Placebo-Teplizumab, AG019 - High Dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AG019 - Low DoseBiological
Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)
TeplizumabDrug
Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
Placebo-AG019Drug
Formulated identically to AG019 with the active ingredient removed.
Placebo-TeplizumabDrug
Formulated identically to teplizumab with the active ingredient removed.
AG019 - High DoseBiological
Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks
AG019 - High DoseBiological
Solid, orally administered capsule - 6 capsules per day for 8 weeks.

Study groups in NCT03751007
Study group	Role	What they receive
AG019 Cohort 1 - Low Dose/Adults	Experimental	Not described Receives: Biological: AG019 - Low Dose
AG019 Cohort 2 - High Dose/Adults	Experimental	Not described Receives: Biological: AG019 - High Dose
AG019 Cohort 3 - Low Dose/Adolescents	Experimental	Not described Receives: Biological: AG019 - Low Dose
AG019 Cohort 4 - High Dose/Adolescents	Experimental	Not described Receives: Biological: AG019 - High Dose
Combination Cohort 1 - Adults	Experimental	Not described Receives: Drug: Teplizumab; Drug: Placebo-AG019; Drug: Placebo-Teplizumab; Biological: AG019 - High Dose
Combination Cohort 2 - Adolescents	Experimental	Not described Receives: Drug: Teplizumab; Drug: Placebo-AG019; Drug: Placebo-Teplizumab; Biological: AG019 - High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-emergent Adverse Events (TEAE)
Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab
Measured: up to 6 months

Secondary outcomes (4)

AG019 in Systemic Circulation
The presence of live L. lactis bacteria in blood will be assessed by plating
Measured: Up to 3 months after initiation of the treatment
L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation
The presence of L. lactis-secreted hPINS or hIL-10 in the blood will be assessed by ELISA (enzyme-linked immunosorbent assay)
Measured: Up to 3 months after initiation of the treatment
AG019 in Feces
The presence of L. lactis (live or dead) in feces will be assessed by Q-PCR (quantitative real-time polymerase chain reaction)
Measured: Up to 8 days after completion of the treatment
C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months
MMTT-stimulated 2-hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.
Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201813 Oct 2021

First posted23 Nov 2018
Study start24 Oct 2018
Primary completion13 Oct 2021
Study completion13 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes type1Studies 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: Randomised
Intervention model: Sequential
Model description: The phase 1b part of the study will enroll 4 sequential AG019 cohorts of up to 6 participants, in ascending dose cohorts and descending age cohorts. All participants in these cohorts will be treated with AG019 in an open label fashion. The phase 2a part of the study will evaluate 2 cohorts of participants administered AG019 and teplizumab. The first 2 participants will be treated with active treatment in an open label fashion. Participants 3-12 will be randomized (4:1) to receive active treatment or placebo in a double-blind fashion.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03751007
Sponsor's protocol ID: AG019-T1D-101
Other IDs: 2017-002871-24, 2017
Status last verified: Jan 2023
First submitted: 8 Nov 2018
Last updated: 1 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Mathieu C, Wiedeman A, Cerosaletti K, Long SA, Serti E, Cooney L, Vermeiren J, Caluwaerts S, Van Huynegem K, Steidler L, Blomme S, Rottiers P, Nepom GT, Herold KC; AG019-T1D-101 Trial Investigators. A first-in-human, open-label Phase 1b and a randomised, double-blind Phase 2a clinical trial in recent-onset type 1 diabetes with AG019 as monotherapy and in combination with teplizumab. Diabetologia. 2024 Jan;67(1):27-41. doi: 10.1007/s00125-023-06014-2. Epub 2023 Oct 2.
PubMed 37782353
Alexander LM, van Pijkeren JP. Modes of therapeutic delivery in synthetic microbiology. Trends Microbiol. 2023 Feb;31(2):197-211. doi: 10.1016/j.tim.2022.09.003. Epub 2022 Oct 8.
PubMed 36220750

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Exploration of Health Literacy in Diabetes in Reunion Island and France
Diabetes type1, Diabetes Type 2
Recruiting
Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes
Type1 Diabetes Mellitus
RecruitingPhase 2
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Diabetes type1, Obesity
Active, not recruitingPhase 2
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Diabetes Mellitus, Type 1, Diabetes type1
Active, not recruitingPhase 2
Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
Diabetes Mellitus, Type 1 Diabetes

All Diabetes type1 trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)
ClinicalTrials.gov ID: NCT03751007
Acronym / sponsor ID: AG019-T1D-101
Conditions: Diabetes type1
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Precigen Actobio T1D, LLCIndustry (pharma, biotech, devices)
Collaborators: Intrexon Actobiotics NV, d/b/a Precigen Actobio
Study start: 24 Oct 2018 (actual)
Primary completion: 13 Oct 2021 (actual)
Study completion: 13 Oct 2021 (actual)
First posted: 23 Nov 2018 (actual)
Results: Posted 1 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This Phase 1b/2a, multi-center study will be conducted in participants with clinical recent-onset type 1 diabetes (T1D).

This study consists of 2 phases:

Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2 different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: The phase 1b part of the study will enroll 4 sequential AG019 cohorts of up to 6 participants, in ascending dose cohorts and descending age cohorts. All participants in these cohorts will be treated with AG019 in an open label fashion. The phase 2a part of the study will evaluate 2 cohorts of participants administered AG019 and teplizumab. The first 2 participants will be treated with active treatment in an open label fashion. Participants 3-12 will be randomized (4:1) to receive active treatment or placebo in a double-blind fashion.

Arm	Type	Receives
AG019 Cohort 1 - Low Dose/Adults	Experimental	Biological: AG019 - Low Dose
AG019 Cohort 2 - High Dose/Adults	Experimental	Biological: AG019 - High Dose
AG019 Cohort 3 - Low Dose/Adolescents	Experimental	Biological: AG019 - Low Dose
AG019 Cohort 4 - High Dose/Adolescents	Experimental	Biological: AG019 - High Dose
Combination Cohort 1 - Adults	Experimental	Drug: Teplizumab, Drug: Placebo-AG019, Drug: Placebo-Teplizumab, Biological: AG019 - High Dose
Combination Cohort 2 - Adolescents	Experimental	Drug: Teplizumab, Drug: Placebo-AG019, Drug: Placebo-Teplizumab, Biological: AG019 - High Dose

Who may qualify

Ages: 12 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Male or non-pregnant, non-lactating females, 18 - 40 years of age (both inclusive) or 12-17 years of age (both inclusive)
Diagnosis of diabetes according to the American Diabetes Association (ADA) recommended criteria
Evidence of auto-antibodies to at least 1 β-cell autoantigen
Stimulated C-peptide measured during 4h Mixed Meal tolerance Test (MMTT) > 0.2 nmol/L
The first administration of AG019 should occur no later than 150 days post diagnosis of diabetes

Key exclusion criteria (13 listed)

Previous history of serious cytokine release syndrome to teplizumab or other humanized anti-CD3 monoclonal antibodies with no or minimal capacity to bind Fc receptors. (Participants enrolled in the second phase of the trial in either Combination Cohort 1 or Combination Cohort 2, only)
Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization
Participation in another investigational drug trial within 12 weeks prior to the first study drug intake and during participation in this study
History of recurrent infections, other autoimmune diseases, cardiac disease, malignancy, or any other (chronic) medical condition which, in the investigator's opinion, could compromise participant safety
Documented history of human immunodeficiency virus (HIV), Hepatitis Virus Type C (HCV), Hepatitis Virus Type B (HBV) infection

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
AG019 - Low DoseSolid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)	Biological	AG019 Cohort 1 - Low Dose/Adults, AG019 Cohort 3 - Low Dose/Adolescents
TeplizumabDaily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).	Drug	Combination Cohort 1 - Adults, Combination Cohort 2 - Adolescents
Placebo-AG019Formulated identically to AG019 with the active ingredient removed.	Drug	Combination Cohort 1 - Adults, Combination Cohort 2 - Adolescents
Placebo-TeplizumabFormulated identically to teplizumab with the active ingredient removed.	Drug	Combination Cohort 1 - Adults, Combination Cohort 2 - Adolescents
AG019 - High DoseSolid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks	Biological	AG019 Cohort 2 - High Dose/Adults, AG019 Cohort 4 - High Dose/Adolescents
AG019 - High DoseSolid, orally administered capsule - 6 capsules per day for 8 weeks.	Biological	Combination Cohort 1 - Adults, Combination Cohort 2 - Adolescents

Primary outcome

Incidence of Treatment-emergent Adverse Events (TEAE)
Time frame: up to 6 months
Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab

4 secondary outcomes

AG019 in Systemic Circulation
Time frame: Up to 3 months after initiation of the treatment
L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation
Time frame: Up to 3 months after initiation of the treatment
AG019 in Feces
Time frame: Up to 8 days after completion of the treatment
C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months
Time frame: up to 12 months

Results and safety

Results posted to the registry on 1 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AG019 Cohort 1 - Low (Single) Dose/Adults	2	2
AG019 Cohort 1 - Low (Repeat) Dose/Adults	5	5
AG019 Cohort 2 - High (Single) Dose/Adults	2	2
AG019 Cohort 2 - High (Repeat) Dose/Adults	5	4
AG019 Cohort 3 - Low (Single) Dose/Adolescents	2	2
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents	4	4
AG019 Cohort 4 - High (Single) Dose/Adolescents	2	2
AG019 Cohort 4 - High (Repeat) Dose/Adolescents	5	4
Combination Cohort 1 - Active AG019/Teplizumab - Adults	10	10
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults	2	2
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents	5	4
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents	1	0

Primary outcome: Incidence of Treatment-emergent Adverse Events (TEAE)

Time frame: up to 6 months. Number. Unit: Events

Measure	AG019 Cohort 1 - Low (Single) Dose/Adults n = 2	AG019 Cohort 1 - Low (Repeat) Dose/Adults n = 5	AG019 Cohort 2 - High (Single) Dose/Adults n = 2	AG019 Cohort 2 - High (Repeat) Dose/Adults n = 5	AG019 Cohort 3 - Low (Single) Dose/Adolescents n = 2	AG019 Cohort 3 - Low (Repeat) Dose/Adolescents n = 4	AG019 Cohort 4 - High (Single) Dose/Adolescents n = 2	AG019 Cohort 4 - High (Repeat) Dose/Adolescents n = 5	Combination Cohort 1 - Active AG019/Teplizumab - Adults n = 10	Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults n = 2	Combination Cohort 2 - Active AG019/Teplizumab - Adolescents n = 5	Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents n = 1
Value	1	6	1	19	1	28	1	19	91	25	22	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AG019 Cohort 1 - Low (Single) Dose/Adults	0 of 2 (0%)	1 of 2 (50%)	0 of 2
AG019 Cohort 1 - Low (Repeat) Dose/Adults	0 of 5 (0%)	3 of 5 (60%)	0 of 5
AG019 Cohort 2 - High (Single) Dose/Adults	0 of 2 (0%)	1 of 2 (50%)	0 of 2
AG019 Cohort 2 - High (Repeat) Dose/Adults	0 of 5 (0%)	2 of 5 (40%)	0 of 5
AG019 Cohort 3 - Low (Single) Dose/Adolescents	0 of 2 (0%)	1 of 2 (50%)	0 of 2
AG019 Cohort 3 - Low (Repeat) Dose/Adolescents	0 of 4 (0%)	2 of 4 (50%)	0 of 4
AG019 Cohort 4 - High (Single) Dose/Adolescents	0 of 2 (0%)	1 of 2 (50%)	0 of 2
AG019 Cohort 4 - High (Repeat) Dose/Adolescents	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Combination Cohort 1 - Active AG019/Teplizumab - Adults	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Combination Cohort 2 - Active AG019/Teplizumab - Adolescents	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37782353Mathieu C, Wiedeman A, Cerosaletti K, Long SA, Serti E, Cooney L, Vermeiren J, Caluwaerts S, Van Huynegem K, Steidler L, Blomme S, Rottiers P, Nepom GT, Herold KC; AG019-T1D-101 Trial Investigators. A first-in-human, open-label Phase 1b and a randomised, double-blind Phase 2a clinical trial in recent-onset type 1 diabetes with AG019 as monotherapy and in combination with teplizumab. Diabetologia. 2024 Jan;67(1):27-41. doi: 10.1007/s00125-023-06014-2. Epub 2023 Oct 2.
Derived from this study: PubMed 36220750Alexander LM, van Pijkeren JP. Modes of therapeutic delivery in synthetic microbiology. Trends Microbiol. 2023 Feb;31(2):197-211. doi: 10.1016/j.tim.2022.09.003. Epub 2022 Oct 8.

Related trials for Diabetes type1

RecruitingObservational study
Exploration of Health Literacy in Diabetes in Reunion Island and France
Diabetes type1, Diabetes Type 2
Recruiting
Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes
Type1 Diabetes Mellitus
RecruitingPhase 2
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Diabetes type1, Obesity
Active, not recruitingPhase 2
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Diabetes Mellitus, Type 1, Diabetes type1
Active, not recruitingPhase 2
Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
Diabetes Mellitus, Type 1 Diabetes

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.

Chantal Mathieu, MD principal investigator

University Hospital of Leuven, Clinical and Experimental Endocrinology

Kevan Herold, MD principal investigator

Yale Center for Clinical Investigation; Yale University

18 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AG019 - Low Dose, Teplizumab and AG019 - High Dose in people with Diabetes type1, run by Precigen Actobio T1D, LLC at 18 sites in 2 countries.

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 13 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: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Belgium. 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 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?

Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-emergent Adverse Events (TEAE) (time frame: up to 6 months). 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 NCT03751007, which also lists 2 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 1 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.