Back to search results

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Autoimmune Disorders

This study is testing new treatments for autoimmune disorders like systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and lupus nephritis (LN). Researchers want to see if combining AD-PluReceptor-NK cells with tafasitamab-cxix and chemotherapy (fludarabine phosphate and cyclophosphamide) is safe and effective. The study will first check the safety of tafasitamab-cxix alone in SSc, SLE, and LN patients. Then, it will find the best dose of AD-PluReceptor-NK cells to use with tafasitamab-cxix and chemotherapy. Finally, it will assess if this combination helps control the disease. You might be able to join if you are 18 or older, have SSc or SLE (including lupus nephritis), and have a positive antinuclear antibody (ANA) test.

Study design
This is an interventional study with a planned enrollment of 47 participants. It is designed in phases to first confirm safety, then find the right dose, and finally assess effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06434363

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~47 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:TafasitamabFludarabine phosphateCyclophosphamideTafasitamab and NK cells

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Event
Measured over Through study completion; an average of 1 year.

Conditions

Autoimmune Disorders
Systemic Sclerosis
Systemic Lupus Erythematosus
Lupus
Lupus Nephritis

Explore related trials

Chronic Graft Versus Host DiseaseLupus GlomerulonephritisSystemic Lupus ErythematosusSystemic SclerodermaAnti-ds DNA AntibodyAntinuclear Antibody

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Chitra Hosing, MD · PRINCIPAL_INVESTIGATOR · MDAnderson Cancer Center

Who to contact

Chitra Chitra Hosing, MD
[email protected]
(713) 745-3219
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 2. Disease activity:
Ruxolitinib
Belumosudil. 4. May be receiving adrenal replacement doses of corticosteroids

What this trial measures

  • Adverse EventThrough study completion; an average of 1 year.

    ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0