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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and optimal dosing of AD-PluReceptor-NK cells combined with tafasitamab and lymphodepleting chemotherapy in patients with autoimmune disorders such as systemic sclerosis (SSc), systemic lupus erythematosus (SLE), including lupus nephritis (LN), and chronic graft versus host disease (GVHD). This Phase I/II trial aims to confirm safety in an initial safety lead-in, find the recommended dose in Phase 1, and assess disease control in Phase 2. The study also seeks to understand immune response and the ability to reduce systemic immunosuppressive therapy at one year. Participants receive tafasitamab and AD-PluReceptor-NK cells intravenously along with lymphodepleting chemotherapy drugs, including fludarabine phosphate and cyclophosphamide, also given intravenously. The study includes a safety lead-in period, a dose escalation phase to identify the best cell dose, and a dose expansion phase to evaluate treatment effects. Treatments are combined and administered under medical supervision during these phases. During the trial, participants undergo regular monitoring for adverse events over an average of one year, with blood tests to assess immune cell persistence and function. Evaluations include safety, tolerability, organ function, and disease activity measures. Participants also follow study visit schedules and complete required assessments to track treatment effects and safety throughout the study period ending in 2030.
CONDITIONS
Brief 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 (SSc) meeting specific classification criteria or systemic lupus erythematosus (SLE) based on accepted guidelines
- Positive antinuclear antibody (ANA) or anti-dsDNA antibody at screening or prior
- Disease activity consistent with study protocols, including specific criteria for SSc, lupus nephritis, or chronic graft versus host disease
- Age 18 to 80 years
- Adequate organ function including blood counts, liver enzymes, oxygen saturation, cardiac and renal function
- Ability to provide informed consent and willingness to follow study procedures
- Effective birth control use during and up to 3 months after study for participants able to have children
You will not qualify if you...
- SSc patients with pulmonary arterial hypertension requiring treatment or severe intestinal complications
- Prior scleroderma renal crisis
- Severe pulmonary dysfunction or low oxygen saturation at rest without oxygen
- Lupus nephritis patients with severe kidney biopsy chronicity or other kidney diseases
- Active severe cardiac manifestations of SLE
- Recent treatment with immunosuppressive drugs except steroids or specific prohibited medications within defined timelines
- Severe infections or uncontrolled systemic diseases
- History of recent malignancies except certain skin or in situ cancers
- Cardiovascular events like heart failure or myocardial infarction within 6 months
- Prior genetically modified T cell therapies or CAR T cell therapy
- History of severe allergic reaction to study drugs
- Medical or psychological conditions that prevent protocol compliance or increase risk
- Active hepatitis C, HIV, syphilis, or other specified infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration as per protocol until completion or discontinuation
Participants receive AD-PluReceptor plus Tafasitamab-cxix and lymphodepleting chemotherapy as part of the study treatment.
Visits as required for administration and monitoring during treatment
Duration - Up to 1 year
Participants are monitored for safety and treatment response for up to 1 year post infusion.
Periodic follow-up visits during the year after treatment
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
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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