Trials / Active Not Recruiting
Active Not RecruitingNCT05020678
NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers
A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Nkarta, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, multi-center, Phase 1 study to determine the safety and tolerability of an experimental therapy called NKX019 (allogeneic CAR NK cells targeting CD19) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B cell acute lymphoblastic leukemia (B-ALL)
Detailed description
This is a dose-finding study of NKX019 and will be conducted in 2 parts: Part 1: dose finding utilizing a "3+3" enrollment schema and safety lead-in to confirm dose for NKX019 in combination with rituximab expansion cohorts (as applicable) Part 2: dose expansion to further evaluate safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumor response in expansion cohorts of patients with large B cell lymphoma (LBCL), mantle cell lymphoma (MCL), indolent lymphoma (IL), Waldenström macroglobulinemia (WM), CLL/ small lymphocytic lymphoma (SLL), and B-ALL.
Conditions
- Lymphoma, Non-Hodgkin
- B-cell Acute Lymphoblastic Leukemia
- Large B-cell Lymphoma
- Mantle Cell Lymphoma
- Indolent Lymphoma
- Waldenstrom Macroglobulinemia
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Aggressive Lymphoma
- Large-cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NKX019 | NKX019 is an investigational allogeneic CAR NK product targeting CD19 on cells. The starting dose of NKX019 in Part 1 is 3 × 10\^8 NK cells (6 × 10\^6/kg for patients \< 50 kg) administered as 3 weekly doses. Part 2 (dose expansion cohorts) will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX019 as determined in Part 1. |
Timeline
- Start date
- 2021-08-20
- Primary completion
- 2025-03-01
- Completion
- 2038-12-01
- First posted
- 2021-08-25
- Last updated
- 2024-12-24
Locations
6 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05020678. Inclusion in this directory is not an endorsement.