Evaluating TT-01488 for treating B-cell malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label Phase I study aims to assess the safety and preliminary efficacy of TT-01488, a non-covalent reversible BTK inhibitor, in adult patients with B-cell malignancies. The study will follow a dose escalation and expansion design, starting with a sentinel cohort at a dose of 50 mg daily. Subsequent patients will be enrolled using a modified 3+3 design to determine the recommended dose for further testing. The study will ultimately evaluate the safety and efficacy of the selected dose in a larger cohort.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Li Jianyong — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Sun Caixia, PhD
• Email: clinicaltrial@transtherabio.com
• Phone: 025-58216298

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.