Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCTLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Same as current
- Acute Myeloid Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
- Phase 1Phase 2
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: There are two parts to this study. The initial Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cells. The second part of the study, the Dose Expansion Phase, to further define the safety and evaluate the initial efficacy of the NEXI-001 T cells at the dose established from the Safety Evaluation Phase.Masking: None (Open Label)Primary Purpose: Treatment
- Between 18 years and 125 years
- Both males and females
The NEXI-001 is an adoptive cellular therapy product which contains populations of antigen-specific CD8+ T cells. The antigen-specific CD8+ T cells in the NEXI-001 T cell product are derived from Peripheral Blood Mononuclear Cells (PBMC) obtained from the original stem cell donor. During the manufac...
The NEXI-001 is an adoptive cellular therapy product which contains populations of antigen-specific CD8+ T cells. The antigen-specific CD8+ T cells in the NEXI-001 T cell product are derived from Peripheral Blood Mononuclear Cells (PBMC) obtained from the original stem cell donor. During the manufacturing process, these cells are primed and expanded ex vivo using nano-size artificial Antigen Presenting Cells (aAPC) loaded with five leukemia associated antigen peptides in combination with a proprietary T cell enrichment and expansion process. The NEXI-001 T cell product is restricted to patients that are HLA-A2.01 allele positive for this study. There are two parts to this study, a Safety Evaluation Phase and a Dose Expansion Phase. The Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cell product, and will consist of Dose Escalation at two dose levels - each with cohorts of three patients. When all three patients at Dose Level 1 have dosed and cleared the DLT period, three additional patients will be enrolled at Dose Level 2. When three patients have cleared the DLT period at the highest dose level, that dose will be advanced to the Dose Expansion Phase. The Dose Expansion Phase will enroll up to 16 additional patients to further define the safety and evaluate the initial anti-tumor efficacy of the NEXI- 001 T cell product at the dose established from the Safety Evaluation Phase. All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 001 T cell product. During this phase, all patients will be monitored for AEs and followed for anti-leukemia response until the end of study visit is complete (up to one year). Additional assessments for safety, disease status, and other secondary and exploratory endpoints will also be monitored during the follow-up period. All patients will be followed for overall survival (OS) from time of disease progression until the last visit of the last patient. During this time, patients will be followed via telephone or other electronic contact at 12 week intervals for monitoring of OS.
- NCT #
- Not Provided
- Principal Investigator: Juan Varela, MD, PhD Principal Investigator