A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies

• Status: Not yet recruiting
• Trial end date: 2028-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TransThera Sciences (Nanjing), Inc.

Criteria

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, unless due to bone marrow involvement due to disease

• Platelets ≥ 50×10^9/L without transfusion within 7 days

• Hemoglobin ≥ 8.0 g/dl without transfusion within 7 days

• 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