ACHIEVE2 - Safety and Preliminary Efficacy of Intravenous TCB008 in Patients With Relapse or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)/AML
NCT Number: NCT06463327
Acronym: ACHIEVE2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acute Myeloid Leukemia|Myelodysplastic Syndromes
Interventions: DRUG: TCB008
Sponsor: TC Biopharm
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2027-06

Summary:
TCB008-003 (ACHIEVE2) is an open-label, multi-center study conducted in 2 parts (dose escalation followed by dose expansion) to evaluate safety, persistence/expansion, and preliminary efficacy of single and multiple intravenous doses of TCB008 in patients with Relapse or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)/AML, who have failed or are intolerant to the current standard of care. The dose escalation will follow a 3+3 design with 3 cohorts planned. Once the recommended dose for further investigation has been confirmed, based on dose-limiting toxicities (DLTs), overall safety data, and preliminary efficacy data, up to 20 patients will be enrolled to into one of each of the three dose expansion cohorts.

Primary Outcome Measures: Recommended Dose of TCB008 for Dose-Expansion, To establish the recommended dose for further investigation in the dose-expansion part of the study, in patients with relapsed or relapsed refractory AML or MDS/AML, or MRD persistent-AML or MDS/AML (dose escalation part only)., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months|Safety and Tolerability of TCB008, Incidence and severity of dose-limiting toxicities (DLTs).

The severity grade will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. Cytokine release syndrome and neurotoxicity will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) criteria., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months|Safety and Tolerability of TCB008, Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). Severity of all AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months
Secondary Outcome Measures: Preliminary Antitumor Activity of TCB008, Preliminary antitumor activity of TCB008 will be determined according to European Leukemia Net 2022 Diagnosis and Management of Acute Myeloid Leukemia guidelines., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months
Other Outcome Measures: Expansion and Persistence of γδ T cells in Peripheral Blood and/or Bone Marrow, This will be measured through concentrations of γδ T cells in the peripheral blood and bone marrow., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months|Evaluate Measurable Residual Disease (MRD) during and after therapy with TCB008, Characterization of the presence of AML blasts in bone marrow and/or peripheral blood, as determined by next-generation sequencing or flow cytometry methodologies., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months|Immunogenicity of TCB008, Measured through the development of anti-TCB008 antibodies., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months|Chimerism of allogeneic γδ T cells in peripheral blood and/or bone marrow, Measured by Human Leukocyte Antigen (HLA) mismatch between donor and patient T cells found in blood and bone marrow samples., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months|Cytokine release profile of allogeneic γδ T cells in peripheral blood and/or bone marrow, Measured by cytokine profiling in serum., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months|Phenotype of allogeneic γδ T cells in peripheral blood and/or bone marrow, Immunophenotyping of T cells (pre- and post-infusion)., The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 29 months