A Phase I, Multicenter, Open Label, and Dose-Escalation Study of TT-01488, Administered Orally in Adult Patients With B-Cell Malignancies

TT01488CN02

This is a multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.

2023-03-30

2026-10-31

2028-10-30

Recruiting

Early phase I

37

Inclusion Criteria: * Participants with histologically confirmed B-cell malignancy, failed or intolerant to either ≥ 2 prior standard/common regimens given in combination or sequentially OR have received 1 prior BTK-containing regimen, relapse/refractory, and with treatment indication: * CLL/SLL treated with prior immunochemistry or BTK inhibitor containing regimen; * DLBCL treated with prior CD20 or anthracyclines containing regimen; * Other types of B-cell NHL treated with prior CD20 containing regimen * Adequate organ function, defined by the following laboratory parameters: * Hematologic: * Absolute neutrophil count (ANC) ≥ 0.75×10\^9/L, and ≥ 0.5×10\^9/L if bone marrow involved * Platelets ≥ 50×10\^9/L without transfusion within 7 days, and ≥ 30×10\^9/L if bone marrow involved * Hemoglobin ≥ 8.0 g/dL without transfusion within 7 days, and ≥ 7.0 g/dL if bone marrow involved * Coagulation: * Prothrombin time (PT) ≤ 1.5 × ULN * Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN * Renal function: * Creatinine clearance ≥ 30 mL/min estimated glomerular filtration rate based on Cockcroft-Gault formula * Liver function: * Total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's disease) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN unless disease-related Exclusion Criteria: * Women who are pregnant or lactating * Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years or which will not limit survival to \< 2 years (Note: these cases must be discussed with the Medical Monitor and/or Investigator) * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or significant screening ECG abnormalities * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction * History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days or with any of the following: * Active graft versus host disease (GvHD); * Cytopenias from incomplete blood cell count recovery post-transplant; * Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \> Grade 1 from CAR-T therapy; * Ongoing immunosuppressive therapy * Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy, including radiation

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2023-11-21