TT-01488 Tablets: TT-01488 tablet will be administered orally once daily per protocol defined schedule.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Dose-Limiting Toxicity (DLT) of TT-01488 — Up to 28 days after first dose Safety and tolerability of TT-01488 as a single agent
Dose recommend for dose expansion (DRDE) — 3 years Safety and tolerability of TT-01488 as a single agent
Maximum Tolerated Dose (MTD), if reached, of TT-01488 — Up to 28 days after first dose Safety and tolerability of TT-01488 as a single agent
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More TransThera Sciences (Nanjing), Inc. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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