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Autism Spectrum DisorderPhase 2NCT06500637

TB006 for Autism Spectrum Disorder

A Phase 2 study testing TB006 in people with Autism Spectrum Disorder, run by Rossignol Medical Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multisite 14-week prospective double-blind placebo controlled parallel-group randomized clinical trial with 14-week open-label extension at the end of double-blind treatment phase for placebo subjects. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
TB006
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
2 sitesUnited States
Study dates
3 Aug 2024to 31 Jan 2027
Phase
Phase 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 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Autism Spectrum Disorder as defined below by the ADOS or ADI-R.
  • Between 18 and 35 years of age at baseline.
  • English included in the languages in which the individual is being raised.
  • Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale.
  • Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
  • Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry.
  • In males and females of childbearing age, two forms of birth control must be used unless they are not sexually active.
  • A caretaker who will accompany the patient to all procedures and has adequate contact with the participant to complete caregiver questionnaires.

Who cannot join

  • LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele.
  • History of infusion reactions to immunoglobulin product.
  • Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior.
  • Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill).
  • Severe prematurity (<34 weeks gestation) as determined by medical history.
  • Current uncontrolled gastroesophageal disorders.
Show all 22Show fewer
  • Current or history of liver or kidney disease as determined by medical history and safety labs (See Laboratory Values Monitoring Plan for specific laboratory values).
  • Genetic syndromes.
  • Congenital brain malformations.
  • Active Epilepsy Diagnosis (Epilepsy Diagnosis is defined as History of two or more unprovoked seizures; Patient with a history of epilepsy who have been off medication without seizures for more than two years do not qualify as active epilepsy).
  • Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
  • Significant negative reaction (i.e., fainting, vomiting, etc.) because of a previous blood draw.
  • Failure to thrive or < 5%ile for Body Mass Index or weight at the time of screening.
  • Concurrent treatment with drug that would significantly interact with the investigational product.
  • Allergy or Sensitivity to ingredients in the investigational product or placebo.
  • Evaluation with the NIH Toolbox or BOSCC within 3 months of entering the study.
  • Planned evaluation with the NIH Toolbox or BOSCC during the study.
  • Pregnancy
  • Current DSM-5 diagnosis requiring alternative pharmacotherapy, e.g., Major Depression, Bipolar Disorder, a psychotic disorder (based on clinical assessment assisted by the Child and Adolescent Symptom Inventory).
  • Refusal to comply with the use of birth control if sexually active.
  • Abnormal vital signs (systolic blood pressure > 180 mmHg or < 90 mmHg; heart rate > 120 beats per minute or < 55 beats per minute; temperature > 101.0o F; oxygen saturation < 90%)
  • Prolonged QTc (defined as > 450ms for males and >470ms for female) or any abnormalities felt by the investigator to be of concern.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alina Espinoza contact

844-ADTF-Research ext. 0

info@autismdiscovery.org

United States2 sites, 2 recruiting

  • Rossignol Medical Center

    Aliso Viejo, California, 92656

    Desiree Chandler, PA, 321-259-7111, info@autismdiscovery.org

    Recruiting

  • Rossignol Medical Center

    Phoenix, Arizona, 85050

    Richard E Frye, M.D., PhD, 321-259-7111, info@autismdiscovery.org

    Richard E Frye, M.D., PhD

    Recruiting

Other trials in United States

About this study

Official title: A Multi-center Double Blind Placebo Controlled Study to Assess the Safety and Efficacy of TB006 for Improving Core Symptoms in Adults With Autism Spectrum Disorder

Multisite 14-week prospective double-blind placebo controlled parallel-group randomized clinical trial with 14-week open-label extension at the end of double-blind treatment phase for placebo subjects. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment.

Read the detailed description

A key molecular mechanism implicated in ASD is immune dysregulation and unchecked neuroinflammation marked by increased microglial activation. Galectin-3 (Gal-3), a galactoside-binding lectin, is critical to activation of neuroinflammation resulting in the proliferation of microglia.7 Gal-3 has been shown to be elevated in individuals with ASD. To inhibit Gal-3's contribution to neuroinflammation, Truebinding has developed TB006, a neutralizing monoclonal antibody against Gal-3. Our overall hypothesis is that TB006 will significantly improve core and associated behavioral symptoms of ASD and be well tolerated with no significant adverse effects in adults with ASD.

Being tested
TB006
Medical subject headings
Autism Spectrum Disorder

What participants receive

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

  • TB006Drug

    TB006 is a humanized immunoglobulin G4 (IgG4) (S228P) type monoclonal antibody that is highly specific and has a high affinity to human Galectin-3 (hGal-3).

Study groups in NCT06500637
Study groupRoleWhat they receive
TB006ExperimentalTB006 is a humanized immunoglobulin G4 (IgG4) (S228P) type monoclonal antibody that is highly specific and has a high affinity to human Galectin-3 (hGal-3). Galectins are a ubiquitous group of proteins found in a variety of cells, tissues, and extravascular spaces, and are involved in numerous metabolic processes and functions. The galectins preferentially bind to β-galactoside derivatives and can cross-link surface glycoproteins by binding galactose residues. The Gal-3 protein plays an important role in different pathogenic conditions, including neurodegenerative and neuroinflammatory disorders. Serum levels of Gal-3 have been found to be elevated in ASD.
Receives: Drug: TB006
PlaceboPlacebo comparatorIdentical IV solution without TB006 product
Receives: Drug: TB006

What is being measured

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

  1. Childhood Autism Rating Scores (CARS)

    The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.

    Measured: Baseline, Week 8 and Week 14

Secondary outcomes (7)

  1. NIH Toolbox

    The NIH ToolBox is a set of short assessments for neurodevelopmental assessments. Direction of score depends on individual subtest.

    Measured: Baseline and Week 14

  2. Clinical Global Impression Scale (CGI)

    The CGI measures the overall disease severity and change. It is completed by a clinician. Scores range from 1 to 7. Lower score is better

    Measured: Baseline, Week 8 and Week 14

  3. Social Responsiveness Scale (SRS)

    The SRS is a caregiver report of autism symptoms Lower Score is Better, Scores range from 30 to 90 (T-scores)

    Measured: Baseline, Week 8, Week 12 and Week 14

  4. Aberrant Behavior Checklist (ABC)

    The ABC is a 58-item consisting five subscales: hyperactivity, irritability, social withdrawal, stereotypic behavior and inappropriate speech in children with developmental disabilities. A higher score indicates more frequent aberrant behaviors.

    Measured: Screening, Weeks 4, 8, 12 and 14

  5. Major Parental Concerns

    The parent nominates 2 most problematic symptoms. Responses are documented in a standardized format documenting frequency, intensity, and impact of behavior. The overall severity is rated using a CGI type scale.

    Measured: Baseline, Week 8, Week 12 and Week 14

  6. Ohio State University Clinical Impressions Scale

    a clinical rating of severity and improvement of 10 autism domains: social interaction, aberrant/abnormal behavior, repetitive/ritualistic behavior, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety/fears, sensory sensitivities, restricted/narrow interests, autism. Severity will be measured at baseline. Each item is rated from 1 (Normal) to 7 (Among the most severe) with a raw score range of 10-70. The raw score will be reported. Higher scores indicate more severe impairment. At the following time points, improvement will be measured. Each item is rated from 1 (Very much improved) to 7 (Very much worse) with a raw score range of 10-70. The raw score will be reported. Higher scores indicate more severe impairment.

    Measured: Baseline and Week 14

  7. Vineland Adaptive Behavior Scale

    A scale to assess adaptive behavior in children with developmental/intellectual disabilities. This is a 135-item parent-reported measure with ratings in the following domains: communication, daily living skills, and socialization. The frequency of each item is scaled from 0 (Never) to 2 (Usually). For each domain, there are 45 items with a maximum score of 90. Change in each domain will be measured by the change in standard score. Standard scores are calculated from the raw scores and based on age norms. A higher standard score in any domain indicates a higher level of adaptive behavior in that domain. Domain standard scores will be used to get a standard composite score. Change in adaptive behavior will be measured by the change in the standard score. A higher composite score indicates higher overall adaptive behavior ability.

    Measured: Baseline, Week 8 and Week 14

Timeline

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

  1. First posted15 Jul 2024
  2. Study start3 Aug 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500637
Sponsor's protocol ID
TB-RMC
Status last verified
Apr 2026
First submitted
8 Jul 2024
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rodriguez JI, Kern JK. Evidence of microglial activation in autism and its possible role in brain underconnectivity. Neuron Glia Biol. 2011 May;7(2-4):205-13. doi: 10.1017/S1740925X12000142. Epub 2012 Jul 6.

    PubMed 22874006

  • Garcia-Revilla J, Boza-Serrano A, Espinosa-Oliva AM, Soto MS, Deierborg T, Ruiz R, de Pablos RM, Burguillos MA, Venero JL. Galectin-3, a rising star in modulating microglia activation under conditions of neurodegeneration. Cell Death Dis. 2022 Jul 20;13(7):628. doi: 10.1038/s41419-022-05058-3.

    PubMed 35859075

  • Wang X, Zhang S, Lin F, Chu W, Yue S. Elevated Galectin-3 Levels in the Serum of Patients With Alzheimer's Disease. Am J Alzheimers Dis Other Demen. 2015 Dec;30(8):729-32. doi: 10.1177/1533317513495107. Epub 2013 Jul 2.

    PubMed 23823143

  • Artik A, Kocaman O, Kara H, Tuncer SC. Galectin-3 levels in school aged children with autism spectrum disorder. Int J Dev Disabil. 2022 Dec 1;69(5):757-761. doi: 10.1080/20473869.2022.2150035. eCollection 2023.

    PubMed 37547549

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TB006 in people with Autism Spectrum Disorder, run by Rossignol Medical Center at 2 sites in United States.

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 8 inclusion and 22 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 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 Alina Espinoza (844-ADTF-Research ext. 0, info@autismdiscovery.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Childhood Autism Rating Scores (CARS) (time frame: Baseline, Week 8 and Week 14). 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 NCT06500637, which also lists 4 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 14 Apr 2026.

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