Actively Recruiting
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
47
Participants Needed
2
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.
CONDITIONS
Official Title
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic sclerosis meeting 2013 ACR/EULAR criteria with positive ANA titer 1:80
- Diffuse systemic sclerosis with disease duration 7 years and modified Rodnan skin score 15 or with lung involvement and progressive interstitial lung disease
- Inadequate response to mycophenolate, cyclophosphamide, rituximab, or tocilizumab for at least 3 months
- Clinical diagnosis of systemic lupus erythematosus per 2019 EULAR/ACR criteria with positive ANA or anti-dsDNA antibody
- For lupus nephritis: active biopsy-proven class III or IV lupus nephritis within 1 year and urine protein-to-creatinine ratio 0.5 g/g despite standard therapy
- For non-renal lupus: active disease with SLEDAI-2K 8 and clinical SLEDAI-2K 6 or major organ involvement despite standard therapy
- History of steroid-resistant chronic graft versus host disease with moderate to severe symptoms not responding or intolerant to ruxolitinib and belumosudil
- Age 18 to 80 years
- Adequate organ function including blood counts, liver enzymes, bilirubin, oxygen saturation, cardiac and renal function
- Recovery to baseline or mild non-hematological toxicities from prior therapy
- Negative pregnancy test for women of childbearing potential
- Willingness to use effective birth control during and up to 3 months after the study
- Ability and willingness to follow study procedures and provide informed consent
You will not qualify if you...
- Pulmonary arterial hypertension requiring treatment in systemic sclerosis
- Rapidly progressive gastrointestinal involvement or prior scleroderma renal crisis in systemic sclerosis
- Severe pulmonary dysfunction with corrected DLCO <40%, FVC <40%, or resting oxygen saturation <92% without oxygen
- Severe chronic changes on kidney biopsy or other kidney diseases besides lupus nephritis
- Active severe cardiac manifestations of systemic lupus erythematosus
- Recent use of immunosuppressive drugs except steroids within specified half-lives before lymphodepleting chemotherapy
- Steroid use 0.5 mg/kg prednisone or >10 mg prednisone daily at lymphodepletion
- Rituximab use within 6 months before lymphodepletion
- Uncontrolled medical, psychological, or social conditions preventing protocol compliance
- Active significant central nervous system disease
- History of malignancies except certain skin cancers, carcinoma in situ, or smoldering myeloma
- Active infections including hepatitis C, syphilis, HIV, HTLV-1/2, or uncontrolled systemic infections
- Recent cardiovascular events or severe heart failure within 6 months
- Prior CAR T cell or genetically modified T cell therapy
- History of severe allergic reactions to study drugs
- Severe uncontrolled organ diseases or infections
- Any medical condition placing the participant at unacceptable risk or interfering with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Chitra Chitra Hosing, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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