Trials / Unknown
UnknownNCT05487651
Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies
Allogeneic Natural Killer T-Cells Expressing CD19 Specific Chimeric Antigen Receptor and Interleukin-15 in Relapsed or Refractory B-Cell Malignancies 2
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Athenex, Inc. · Industry
- Sex
- All
- Age
- 3 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multi-center study to evaluate the safety of KUR-502 in subjects with refractory/relapsed B-cell NHL or leukemia (ALL or CLL).
Detailed description
KUR-502 will be manufactured from leukapheresis products from healthy donors. Subjects will be enrolled into 2 parallel cohorts (Cohort A \[non-ALL\] and Cohort B \[ALL\]). Each cohort will undergo dose escalation independently. Three (3) dose levels will be evaluated in the ANCHOR and ANCHOR2 studies combined (1×107/m2, 3×107/m2, 1×108/m2). Dose levels are defined based on the number of transduced KUR-502 cells. Body surface area (BSA) will be capped at 2.4 m2. Subjects will receive \<1×104 allogeneic T cells/kg at any dose level. The MTD will be determined once dose escalation is completed, and all subjects are evaluable for DLT. If there is no DLT that determines an MTD, a maximum dose level will be declared. Dose escalation will stop when 6 subjects have been treated at the MTD or highest dose level.
Conditions
- NHL, Relapsed, Adult
- B-cell Lymphoma
- B-cell Leukemia
- DLBCL - Diffuse Large B Cell Lymphoma
- ALL, Adult B Cell
- ALL, Childhood
- CLL/SLL
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | KUR-502 | KUR-502 (CD19.CAR-aNKT cells) consists of transduced allogeneic natural killer T cells (aNKT) genetically modified with additional features to enhance their anti-tumor activity against CD19+ B-cell malignancies. Following intravenous (IV) infusion, the product is expected to kill CD19+ tumor cells by direct interaction with the chimeric antigen receptor (CAR), and activation of the NKT cells to kill tumor through their innate cell killing. |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2023-12-01
- Completion
- 2024-12-01
- First posted
- 2022-08-04
- Last updated
- 2023-05-18
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05487651. Inclusion in this directory is not an endorsement.