Phase 1Active, not recruiting
Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome.
Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome, Including Long-term Safety Follow-up
- Sponsor
- Kite, A Gilead Company (Industry)
- Enrolment
- 24 planned
- Conditions
- Acute Myeloid Leukemia; Myelodysplastic Syndromes
- Interventions
- SPRX002; ARC-T Cells; Cyclophosphamide; Fludarabine
- Ages
- adults, older adults
- Registry
- NCT05457010
Full record on ClinicalTrials.gov
From the registry
Master Protocol: The main goal of this master clinical trial study is to assesses the safety, tolerability, pharmacokinetic (PK), Pharmacodynamic (PD) in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The goal of the Arm 1 study is to assess the safety, tolerability, PK, and PD of the study drugs, Antigen Receptor Complex T (ARC-T) cells and CD123-specific soluble protein antigen-receptor X-linker (SPRX002), in participants with relapsed or refractory AML or MDS. The primary objective of this study is to assess the safety profile (including any dose-limiting toxicity (DLT)), to determine recommended Phase 2 dose (RP2D) of the investigational agents when infused in participants with relapsed and refractory AML or MDS.
Primary outcomes
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
- Percentage of Participants Experiencing Dose-Limiting Toxicities (DLT)
- Recommended Phase 2 Dose (RP2D)
History
Primary completion expected
Last registry update
Started
Registered