Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPRX002 · 1 trial · 2 indications
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 |
|---|---|---|
| ARM 1: SPRX002 + ARC-T Cells | EXPERIMENTAL | Participants with relapsed or refractory AML or high-risk MDS will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of ARC-T cells and multiple doses of SPRX002. |
| 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. Administered intravenously. |
| 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). Administered intravenously. |
| Cyclophosphamide | DRUG | Administered intravenously |
| Fludarabine | DRUG | Administered intravenously |
Key Inclusion Criteria: 1. 18 years or older 2. For AML Individuals: 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 ...
SPRX002 is an investigational monoclonal antibody being developed by Arcellx, Inc. for the treatment of acute myeloid leukemia. It is in Phase 1 clinical development and has not been approved by the FDA. It is being studied in patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.
SPRX002 is being evaluated for the treatment of acute myeloid leukemia, specifically in patients with relapsed or refractory disease. It is also being studied in patients with high-risk myelodysplastic syndrome. The drug is investigational and has not been approved for any indication.
SPRX002 is being developed by Arcellx, Inc., a biopharmaceutical company. Arcellx trades on the Nasdaq under the ticker symbol ACLX. The company is responsible for the clinical development of SPRX002.
SPRX002 is in Phase 1 clinical development. The only trial of SPRX002 is a Phase 1 study that is currently active but not recruiting. There are no completed trials of SPRX002, and the drug remains investigational.
SPRX002 is being studied in a single Phase 1 clinical trial, NCT05457010, titled "Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome." The trial is active but not recruiting, has enrolled 24 patients, and is conducted in the United States.