Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPRX002 · 1 trial · 2 indications
The RP2D will be determined based on the totality of data, including the maximum tolerated dose (MTD); if applicable, and other endpoints such as observed efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and other safety endpoints (adverse events (AEs), laboratory assessment, vital signs, and physical examinations)
| Arm | Type | Description |
|---|---|---|
| CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells) | EXPERIMENTAL | Arm 1: Phase 1 Study of monovalent CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T cell (ARC-T Cells) for the Treatment of Patients with Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes |
| Name | Type | Description |
|---|---|---|
| SPRX002 | BIOLOGICAL | SPRX002 is a soluble protein with a "TAG" region to which ARC-T cells bind and a binding region targeting CD123 |
| ARC-T Cells | BIOLOGICAL | ARC-T Cells is a genetically modified autologous T-cell product. The T cell has a binding domain chimeric antigen receptor (CAR), which specifically binds to the "TAG" protein of the soluble protein antigen-receptor x-linker (sparX; specifically, SPRX002). When ARC-T cells bind to a "TAG" and the SPRX protein is bound to its target (in this case CD123), ARC-T cells are capable of activation, expansion, and killing (based on preclinical experiments). |
Inclusion Criteria: 1. 18 years or older 2. For AML Subjects: WHO-confirmed AML, other than APL, with no standard treatment options available (WHO AML Criteria 2016) a. Relapsed or refractory disease after at least 1 line of therapy, as defined by the following: i. Relapsed: Bone marrow blasts ...
SPRX002 is an investigational monoclonal antibody being studied for the treatment of acute myeloid leukemia (AML). It is currently in Phase 1 clinical development for patients with relapsed or refractory AML or high-risk myelodysplastic syndromes.
SPRX002 is being developed by Arcellx, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ACLX. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with acute myeloid leukemia.
SPRX002 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively enrolling or has enrolled patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.
SPRX002 is being evaluated in a Phase 1 clinical trial registered as NCT05457010. The study is titled 'Phase I Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory AML or High-risk MDS' and is being conducted in the United States with a planned enrollment of 24 participants.
SPRX002 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat acute myeloid leukemia, though the exact mechanism of action is not publicly detailed.