IRB Number: STU00221831
ClinicalTrials.gov Identifier: NCT06581198
PI Name: Georges Georges, MD
Eligibility Criteria:

• Men and women with SLE, aged >= 18 years and =< 65 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
• Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of >= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
• Active lupus nephritis without signs of significant chronicity
• SLEDAI-2K Criteria at screening: SLEDAI-2K score >= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome".
• Inadequate response at screening to at least two LN treatment regimens

For more information, read the study details on clinicaltrials.gov.

IRB Number: STU00221295
ClinicalTrials.gov Identifier: NCT06121297
PI Name: Irene Blanco, MD
Eligibility Criteria:

• Age ≥18 and ≤65
• A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE.
• Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.
• For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
• For non-renal SLE subjects only: Active, moderate to severe SLE

For more information, read the study details on clinicaltrials.gov.

IRB Number: STU00220454
ClinicalTrials.gov Identifier: NCT06154252
PI Name: George Georges, MD
Eligibility Criteria:

• Age ≥18 and ≤75
• A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria
• Diagnosis of DM, ASyS, IMNM based on the presence of serum myositis-specific antibodies
• Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography
• Presence of muscle weakness

For more information, read the study details on clinicaltrials.gov.

IRB Number: STU00220737
ClinicalTrials.gov Identifier: NCT06328777
PI Name: George Georges, MD
Eligibility Criteria:

• Age ≥18 and ≤70
• A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
• Early active disease
• Evidence of significant skin, pulmonary, renal, or cardiac involvement

For more information, read the study details on clinicaltrials.gov.

IRB Number: STU00220905
ClinicalTrials.gov Identifier: NCT04047628
PI Name: George Georges, MD
Eligibility Criteria:

1. Age 18 to 55 years, inclusive, at the time of the screening Visit -2.
2. Diagnosis of MS according to the 2017 McDonald Criteria139.
3. EDSS ≤ 6.0 at the time of randomization (Day 0).
4. T2 abnormalities on brain MRI that fulfill the 2017 McDonald MRI criteria for dissemination in space139. A detailed MRI report or MRI images must be available for review by the site neurology investigator.
5. Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2). The two disease activity episodes will be a clinical MS relapse or MRI evidence of MS disease activity and must meet all the criteria described below:
1. At least one episode of disease activity must occur following ≥ 1 month of treatment with one of the following: (i) an oral DMT approved by the FDA for the treatment of relapsing MS, or (ii) a monoclonal antibody approved by the FDA for the treatment of relapsing MS, or (iii) rituximab. Qualifying DMTs include: dimethyl fumarate, diroximel fumarate, monomethyl fumarate, teriflunomide, cladribine, daclizumab, ponesimod, siponimod, ozanimod, fingolimod, rituximab, ocrelizumab, natalizumab, alemtuzumab, ublituximab, and ofatumumab, and
2. At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and
3. At least one episode of disease activity must be a clinical MS relapse (see item c.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical MS relapse or MRI evidence of disease activity (see item c.ii. below):

i. Clinical MS relapse must be confirmed by a neurologist's assessment and documented contemporaneously in the medical record. If the clinical MS relapse is not documented in the medical record, it must be approved by the study adjudication committee (see Section 3.5), and ii. MRI evidence of disease activity must include ≥ 1 unique active lesion on one or more brain or spinal cord MRIs. Detailed MRI reports or MRI images must be available for review by the site neurology investigator. A unique active lesion is defined as either of the following:

1. A gadolinium-enhancing lesion, or 2. A new non-enhancing T2 lesion compared to a reference scan obtained not more than 36 months prior to the screening visit (Visit -2).

6. Candidacy for treatment with at least one of the following high efficacy BAT DMTs: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab and rituximab. Candidacy for treatment for each BAT DMT is defined as meeting all of the following:

1. No prior disease activity episode, as defined in Inclusion Criterion #5, with the candidate BAT DMT, and
2. No contraindication to the candidate BAT DMT, and
3. No treatment with the candidate BAT DMT in the 12 months prior to screening.

7. Completion of COVID-19 vaccination series, according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations, ≥ 14 days prior to randomization (Day 0).

8. Positive for VZV antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least 4 weeks prior to randomization (Day 0).

9. Insurance approval for MS treatment with at least one candidate BAT DMT (see Inclusion Criterion #6).

10. Ability to comply with study procedures and provide informed consent, in the opinion of the investigator.

11. Females of childbearing potential (defined in Section 5.4.3.1) and males with female partners of childbearing potential are required to adhere to the contraception provisions of Section 5.4.3.1.

12. For participants who use medicinal or recreational marijuana, willingness to substitute MARINOL® if randomized to AHSCT (Section 5.4.2.6).

For more information, read the study details on clinicaltrials.gov.

IRB Number: STU00217840
ClinicalTrials.gov Identifier: NCT06201416
PI Name: Eric Ruderman, MD
Eligibility Criteria:

• Body mass index (BMI) <35 kg/m^2, inclusive
• Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Moderate-to-severe active disease
• Clinical and/or ultrasound evidence of synovitis
• Prior inadequate response to or unable to tolerate available RA therapies
• Stable doses of RA medications for at least 30 days
• Use of highly effective methods of contraception

For more information, read the study details on clinicaltrials.gov.