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NCT06434363 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
A Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 2
- Study locations
NCT06434363 is a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 47 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06434363, a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine phosphate
- DRUG Tafasitamab
- DRUG Tafasitamab and NK cells
Study Locations (2)
Texas
- MD Anderson Cancer Center - Houston
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06434363
The ClinicalTrials.gov registry entry for NCT06434363 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (88% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06434363 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06434363 about?
NCT06434363 is a clinical study titled "Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders". 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 dis...
What is the current status of trial NCT06434363?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2024-07-31. Estimated completion is 2030-12-31.
What conditions does trial NCT06434363 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Lupus, Autoimmune Disorders.
What interventions are being tested in trial NCT06434363?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine phosphate (DRUG), Tafasitamab (DRUG), Tafasitamab and NK cells (DRUG).
Who is sponsoring clinical trial NCT06434363?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06434363 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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