DR-0201 in Subjects With Autoimmune Diseases

Inclusion Criteria:

1. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)diagnosis of 1 of the following active autoimmune diseases: SLE or CLE (both musthave CLASI > 8 at both screening and baseline visits); pSS; PM/DM (probable ordefinite); and/or dcSSc (of < 3 years duration).

2. Subjects with SLE, CLE, or dcSSc must be willing to undergo skin biopsies atbaseline and 2 skin biopsies during the treatment period; subjects with pSS must bewilling to undergo salivary gland biopsies at baseline and 2 salivary gland biopsiesduring the treatment period; subjects with PM must be willing to undergo musclebiopsies at baseline and 2 muscle biopsies during the treatment period; and subjectswith DM must be willing to undergo muscle biopsies at baseline and 2 muscle biopsiesduring the treatment period or they may choose to undergo skin biopsies instead.

3. Between 18 and 75 years of age, inclusive, of either gender and of any race.

4. Stable, but active disease, such that in the opinion of the Investigator, it isunlikely that a change in the subject's therapeutic regimen would be required duringthe subsequent 3 to 4 months.

5. Photographs of skin lesions, when applicable, must be submitted for review toconfirm that the lesions are suitable for punch biopsy and caused by SLE, CLE, or DMdisease activity. Such confirmation by the Sponsor must be received prior toenrollment.

6. Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form (ICF).

7. Use of a highly effective contraceptive measure (< 1% failure rate; see Section 13.1) for all non-sterilized males and all females of childbearing potential duringstudy through 120 days after last DR-0201 dose. Females of childbearing potentialneed to have a negative serum pregnancy test within 7 days prior to the first doseof DR-0201. Females who are not of childbearing potential (i.e., who are consideredto be post-menopausal [≥ 12 months of non-therapy amenorrhea] or surgically sterile [absence of ovaries and/or uterus]) are not required to have a pregnancy test or usecontraception.

Exclusion Criteria:

1. Severe manifestation of the selected autoimmune rheumatic diseases under study thatcould impact participant safety, or is likely to require interventions that willaffect investigational drug PD.

2. Receipt of super-high potency (e.g., clobetasol propionate) or high potency (e.g.,fluocinonide) topical corticosteroids within 1 month prior to screening.

3. Received dose changes of mycophenolate mofetil, methotrexate, leflunomide,azathioprine, or nonsteroidal topical immunosuppressants within 28 days prior to Day 1 or dose changes of oral or topical corticosteroids within 14 days prior to Day 1.

4. Required regular use of medications known to cause, as a major side effect, drymouth/eyes, and which have not been on a stable dose for at least 30 days prior toscreening, or any anticipated change in the treatment regimen during the course ofthe study.

5. Receipt of any of the following medications within 6 months of Day 1:cyclophosphamide, leflunomide > 20 mg/day, abatacept.

6. Receipt of any mAb or experimental immunomodulator within 28 days or 5 publishedhalf-lives prior to Day 1, whichever is shorter.

7. Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.

8. Receipt of rituximab or other B cell depleting biologics without return of CD19 orCD20 count to above the LLN.

9. Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation,total lymphoid irradiation, chimeric antigen receptor T cell (CAR-T) or T cellvaccination therapy.

10. Known history of a primary immunodeficiency or an underlying condition such as knownhuman immunodeficiency virus (HIV) infection, positive result for HIV infection,splenectomy, or any underlying condition that predisposes the subject to infection.

11. Subjects with AST > 2.5 × upper limit of normal (ULN), ALT > 2.5 × ULN, totalbilirubin > 1.5 × ULN (unless due to Gilbert's syndrome), total immunoglobulin < 500g/dL, neutrophil count < 1000/μL, platelet count < 85,000/μL, hemoglobin < 10 g/dL,glycosylated hemoglobin > 8%, total lymphocyte count < 300/μL, or glomerularfiltration rate < 50 mL/min/1.73 m2.

12. History of a hypersensitivity reaction or anaphylaxis to a previous mAb or humanimmunoglobulin therapy.

13. Active infection or a history of serious infections as follows:

14. Use of antimicrobials (antibacterials, antivirals, antifungals, orantiparasitic agents) for an infection within 30 days prior to the first doseof DR-0201. Topical treatments may be allowed at the Medical Monitor'sdiscretion.

15. History of opportunistic infections in the last 2 years.

16. Recurrent or chronic infection, or other active infection, that in the opinionof the Investigator might cause this study to be detrimental to the subject.

17. Symptomatic herpes zoster within 3 months prior to screening or recurrentherpes zoster or herpes simplex infections.

18. History of tuberculosis (active or latent) irrespective of treatment status.

19. Any history of viral hepatitis: hepatitis B virus, hepatitis C virus (HCV),hepatitis E virus. HCV is acceptable if HCV ribonucleic acid (RNA) isundetectable for at least 3 months after completion of direct-acting antiviraltherapy.

20. Major surgery within 28 days prior to Day 1.

21. QT interval corrected for heart rate (QTc) > 480 msec, based on the mean oftriplicate ECGs. The QTc is the QT interval corrected using Fridericia's formula (QTcF).

22. Evidence of significant, uncontrolled concurrent disease that could affectcompliance with the study(e.g., chronic obstructive pulmonary disease).

23. Previous exposure to DR-0201.

24. Participation in a clinical trial and has received an investigational product withinthe following time period prior to screening in the current study: 3 months (forbiologic therapies) or 1 month (for non-biologic therapies), 5 half-lives, or twicethe duration of the biological effect of the investigational product (whichever islonger).

25. Unstable lifestyle factors (including but not limited to excessive alcohol use,heavy nicotine use, or substance abuse), to the extent that, in the opinion of theInvestigator, they would interfere with the ability of a subject to complete thestudy.

26. Diagnosis or history of malignant disease within 5 years prior to baseline, with theexceptions of basal cell or squamous epithelial carcinomas of the skin that havebeen resected or cervical carcinoma in situ, with no evidence of recurrence withinthe 5 years prior to baseline.