Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients

NCT06802328 | Unknown

• 1 other identifier: 161148
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.

Conditions

Non-Active Secondary Progressive Multiple Sclerosis

Keywords

multiple sclerosis; non-active secondary progressive multiple sclerosis; MS; expanded access; anti-cd3 monoclonal antibody; foralumab; nasal

Interventions

Foralumab TZLS-401 50 µg DRUG

Foralumab 50 µg/dosing day for patients who have failed current therapies. Patients will be dosed in 3-week cycles, with foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". Patients will receive Day 1 doses of nasal foralumab under supervision at the Center for Clinical Investigation at BWH.

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of MS (according to the 2010 McDonald criteria).
• Age 25-75 years old.
• Clinical diagnosis of non-active SPMS, as defined by the absence of relapses for 2 years.
• MRI imaging consistent with a diagnosis of MS at any time point.
• Score on the Expanded Disability Status Scale (EDSS) of 2.5-7.5.
• Have failed standard of care treatment and continued to decline clinically for at least 6 months.
• Adequate hematologic parameters without ongoing transfusion support:
• Hemoglobin (Hb) ≥ 9 g/dL
• Platelets ≥ 100 x 109 cells/L
• Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula.
• Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN.
• QT interval corrected for rate (QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening
• Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male patients must agree to use highly effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 90 days after the completion of study treatment.
• Patients whose immunizations are fully up to date at the Screening, according to the assessment of their primary care physician and neurologist.

You may not qualify if:

• Need for corticosteroid treatment (oral or intravenous) within the past 30 days or anticipated need within 30 days of foralumab therapy initiation.
• Treatment with Ocrevus® (ocrelizumab), Rituxun® (rituximab), Kesimpta® (ofatumumab), Truxima® (rituximab-abbs) within the past 90 days.
• Treatment with Lemtrada® (alemtuzumab) and Mavenclad® (cladribine) within the past 1 year.
• Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate or natalizumab within the past 90 days.
• Inability to tolerate nasally administered medications.
• Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days, or anticipated need during the study.
• Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 8 months.
• Active COVID-19 disease.
• COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing).
• Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.
• Female patients of childbearing age will undergo a pregnancy test and be excluded from the study if positive.
• Active malignancy within 5 years.
• Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes.
• Neutropenia or an absolute neutrophil count of \< 1,000 cells/mL or other indicators of severe immunosuppression.
• Patients with a history of gadolinium allergy.

Sponsors & Collaborators

• Tiziana Life Sciences LTD: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

AVAILABLE

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Tiziana

CONTACT

1-833-849-4262; ms@tizianalifesciences.com

Keeren Shah

CONTACT

1-833-849-4262; ms@tizianalifesciences.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 31, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-03

Locations

US (1)