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A Study of ATG-201 in Adult Participants With Autoimmune Diseases

ConditionsSystemic Lupus ErythematosusSystemic Sclerosis (SSc)Sjogren's DiseaseAutoimmune Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntengene Biologics Limited

About this trial

This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who give consent to this study participation and sign informed consent form.

Participants at least 18 years of age inclusive at screening visit.

Must be able to adhere to the study visit schedule and other protocol .requirements.

Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.

Disqualifiers

Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).

Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.

Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.

Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • ATG-201

    Drug

    ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19.

Treatment groups

149 Participants
are divided into 1 treatment group
Group A: ATG-201Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and TolerabilitySafety and Tolerability

Incidence and severity of adverse events (AEs), CRS.

Time frame
48 weeks

Secondary outcomes

Other outcomes

1

To evaluate the PK of ATG-201

Serum concentrations of ATG-201

Time frame
48 weeks
2

Detection of anti-drug antibodies

Detection of anti-drug antibodies

Time frame
48 weeks
3

Change from baseline in B lymphocyte cell numbers in peripheral bloo

B lymphocyte cell numbers and change from baseline in peripheral blood

Time frame
48 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Antengene Biologics Limited

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: