Trials / Withdrawn
WithdrawnNCT04893915
Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS
A Phase 2 Study of Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) will receive lymphodepleting chemotherapy (Flu/Cy) and two infusions of cytokine-induced memory-like NK cells at the previously defined maximum tolerated dose (MTD), fourteen days apart. Low dose rhIL-2 will be administered to patients for in vivo expansion following cell infusion. Patients will be assessed for anti-leukemic efficacy and safety. Re-infusion of patients who relapsed after clinical response will be considered.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cytokine-induced memory-like NK cells | Cell product processing is performed at the Siteman Cancer Center Biological Therapy Core or another FACT-accredited cellular therapy production facility that can manufacture the product per the IND CMC. |
| DRUG | Fludarabine | -Lymphodepleting regimen |
| DRUG | Cyclophosphamide | -Lymphodepleting regimen |
| PROCEDURE | Donor Leukapheresis | -Apheresis will be performed via peripheral IVs or central line, as determined by the apheresis team. |
| DRUG | Interleukin-2 | -IL-2 will start approximately 2-4 hours after the NK cell infusions. |
Timeline
- Start date
- 2022-06-30
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2021-05-20
- Last updated
- 2022-03-11
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04893915. Inclusion in this directory is not an endorsement.