Trials / Recruiting
RecruitingNCT06434363
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Primary Objectives: To determine the safety, tolerability and optimal cell dose of AD-PluReceptor plus Tafasitamab cxix and lymphodepleting chemotherapy in patients with systemic sclerosis and systemic lupus erythematosus (including lupus nephritis). Secondary Objectives: To assess the overall response rate. To evaluate the persistence and kinetics of infused allogeneic donor AD-PluReceptor cells in the recipient. To conduct comprehensive immune reconstitution studies. To evaluate the number of patients not requiring any systemic immunosuppressive therapy for their autoimmune disease at 1 year post infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tafasitamab | Given by vein (IV) |
| DRUG | Fludarabine phosphate | Given by vein (IV) |
| DRUG | Cyclophosphamide | Given by vein (IV) |
| DRUG | Tafasitamab and NK cells | Given by vein (IV) |
Timeline
- Start date
- 2024-07-31
- Primary completion
- 2028-12-31
- Completion
- 2030-12-31
- First posted
- 2024-05-30
- Last updated
- 2026-04-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06434363. Inclusion in this directory is not an endorsement.