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New treatment option for Autoimmune Disorders
Official title Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
ClinicalTrials.gov ID: NCT06434363
What this study is testing
What is Tafasitamab?
Tafasitamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- SSc Specific A. Diagnosis of SSc defined as follows: i) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism...
- Progressive ILD as defined by Raghu et al47 (≥ 2 of the following): (a) worsening respiratory symptoms (b) physiological evidence of disease...
- FVC \ 20%. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab...
- Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening or prior to screening.
- For LN people only: Active, biopsy-proven lupus nephritis (kidney biopsy should have been done within 1 year of study enrollment) class III or IV...
You likely can't join if
- SSc specific exclusion criteria
- SSc related pulmonary arterial hypertension (PAH) requiring active treatment.
- Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular...
- Prior scleroderma renal crisis.
- Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \< 40% or FVC \< 40% of predicted or O2 saturation \< 92% at rest without supplemental...
- For LN people only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+...
See the full eligibility criteria
Who can join
- SSc Specific A. Diagnosis of SSc defined as follows: i) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody...
- Progressive ILD as defined by Raghu et al47 (≥ 2 of the following): (a) worsening respiratory symptoms (b) physiological evidence of disease progression (≥ 1 of the following): (i) Absolute decline in FVC ≥ 5% predicted...
- FVC \ 20%. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and/or tocilizumab SLE Specific 1. A clinical diagnosis of SLE, based...
- Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening or prior to screening.
- For LN people only: Active, biopsy-proven lupus nephritis (kidney biopsy should have been done within 1 year of study enrollment) class III or IV, with or without the presence of Class V, using the 2018 Revised...
- Diagnosed with active SLE. people with either LN or without LN will be eligible if they meet the following criteria: a. For LN people: urine protein-to-creatinine ratio (UPCR) ≥0.5 g/g on 2 first morning void urine...
- If a subject is currently receiving:
- A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject...
- Regarding oral corticosteroid, doses \<0.5 mg/kg prednisone equivalent at the time of enrollment are required. Steroid taper to ≤10 mg prednisone equivalent prior to lymphodepleting chemotherapy is recommended. Chronic...
- Progressive symptoms / manifestations of chronic GVHD despite receiving prednisone 1 mg/kg/day (or equivalent) for two weeks
- Stable symptoms / manifestations of chronic GVHD after four to six weeks of prednisone ≥0.5 mg/kg/day (or equivalent)
- Inability to taper prednisone to \<0.5 mg/kg/day (or equivalent) without worsening of symptoms / manifestations of chronic GVHD
- Disease activity:
- Manifestations/symptoms of chronic GVHD rated as moderate to severe on the NIH chronic GVHD global severity score.
- Manifestations/symptoms of chronic GVHD that have not adequately responded or intolerant to both:
- Ruxolitinib
- Belumosudil.
- May be receiving adrenal replacement doses of corticosteroids For SLE, SSc, and chronic GVHD
- Able to provide informed consent.
- Age ≥18 to ≤80 years.
- Adequate organ function i) Peripheral blood absolute neutrophil count (ANC) ≥ 1 × 109/L, unless the neutropenia is deemed to be caused by the underlying autoimmune disease. ii) Hemoglobin ≥ 8 g/dl, unless the anemia is...
What rules you out
- SSc specific exclusion criteria
- SSc related pulmonary arterial hypertension (PAH) requiring active treatment.
- Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.
- Prior scleroderma renal crisis.
- Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \< 40% or FVC \< 40% of predicted or O2 saturation \< 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry. SLE specific...
- For LN people only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following individual biopsy features: total...
- The presence of biopsy-proven kidney disease other than active lupus nephritis
- Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \< 40% or FVC \< 40% of predicted or O2 saturation \< 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.Active, severe...
- Treatment with any immunosuppressive drug (except steroids) within 5 half lives prior to administration of lymphodepleting therapy. Immunosuppressive Drug Five Half Lives Half Life of the Drug Axatilimab 23 days 108...
- Receiving any immunosuppressive medications that are not being used for management of chronic GVHD.
- Treatment with steroids ≥0.5 mg/kg prednisone daily or equivalent at the time of enrollment and \>10 mg prednisone daily or equivalent at the time of lymphodepletion.
- Received rituximab within 6 months of lymphodepletion. Exclusion Criteria for SLE, SSc, and chronic GVHD people are excluded from the study if any of the following medical conditions apply:
- Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the...
- Active, clinically significant central nervous system pathology
- Prior history of malignancies or lymphoproliferative disease, following are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or breast or Smoldering Myeloma. History of malignancy...
- Active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and/or type 2 (HTLV-1 and/or HTLV-2
- Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti- infective treatment at screening or within 72 hours before LD chemotherapy, or 5 days before AD-PluReceptor administration.
- History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina...
- Prior CAR T cell therapy, genetically modified T cell therapy.
- Treatment with cyclophosphamide within 3 days, tocilizumab within 9 weeks, and/or any other immunosuppressive drug (excluding steroids) within 5 half-lives prior to administration of lymphodepleting chemotherapy...
- Treatment with mycophenolate mofetil within 4 days prior to administration of lymphodepleting chemotherapy. For patients who will receive tafasitamab alone may continue mycophenolate mofetil throughout the study.
- History of anaphylactic or severe systemic reaction to FLU, CY, Tafasitamab, or any of their metabolites.
- Uncontrolled infection at screening.
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (on TPN), pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled...
- Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.