RecruitingPhase 1Phase 2NCT06434363

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

47 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy combined with an immune-targeting drug (tafasitamab) and chemotherapy in people with severe autoimmune diseases — specifically systemic sclerosis (scleroderma) with lung involvement or significant skin disease — that have not responded to standard treatments. **You may be eligible if...** - You have been diagnosed with systemic sclerosis (scleroderma) meeting the 2013 ACR/EULAR criteria - You have a positive ANA (antinuclear antibody) test at a meaningful level - You have either: diffuse scleroderma with significant skin involvement (mRSS ≥15), OR lung scarring confirmed by CT scan with progressive lung function decline — all within 7 years of your first non-Raynaud's symptom - Other autoimmune conditions (such as lupus or inflammatory myositis) may also be eligible — ask the study team **You may NOT be eligible if...** - Your disease has been present for more than 7 years (from first non-Raynaud's symptom) - You have other serious medical conditions, infections, or recent major organ issues - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTafasitamab

Given by vein (IV)

DRUGFludarabine phosphate

Given by vein (IV)

DRUGCyclophosphamide

Given by vein (IV)

DRUGTafasitamab and NK cells

Given by vein (IV)


Locations(2)

MD Anderson Cancer Center

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06434363


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