Actively Recruiting
A Phase I, Multicenter, Open Label, Dose-Escalation Study of Oral TT-01488 in Adults With B-Cell Malignancies
Led by TransThera Sciences (Nanjing), Inc. · Updated on 2023-11-21
37
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of TT-01488, an oral tablet that reversibly inhibits BTK, in adults with B-cell malignancies who have not responded to or tolerated previous treatments. This open-label Phase I study aims to find a suitable dose for further testing and to assess how the drug behaves in the body. The study is sponsored by TransThera Sciences (Nanjing), Inc. The trial has two parts: a dose escalation phase where TT-01488 tablets are given once daily in 28-day cycles at increasing doses to find the recommended dose for expansion; followed by a dose expansion phase where this dose is further tested for safety and early effectiveness. The dose escalation uses a modified 3+3 design starting at 50 mg daily, with the goal of identifying a recommended Phase II dose based on safety, drug levels, and response. Participants will take daily tablets and undergo assessments including monitoring for dose-limiting toxicities within 28 days of the first dose, along with safety and response evaluations over three years. Researchers will track adverse events, drug concentration in the blood, and measures like disease control and survival. The study is non-randomized and open-label, and participant involvement may last up to three years depending on outcomes and follow-up needs.
CONDITIONS
Brief Title
A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed B-cell malignancy
- Failed or intolerant to two or more prior standard or common treatment regimens or received one prior BTK-containing regimen
- Relapsed or refractory disease with treatment indication for CLL/SLL treated with immunochemistry or BTK inhibitors, DLBCL treated with CD20 or anthracyclines, or other B-cell NHL treated with CD20
- Adequate organ function including hematologic, coagulation, renal, and liver parameters as defined by laboratory tests
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Prior malignancy except treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer disease-free for at least 2 years
- Significant cardiovascular disease such as uncontrolled arrhythmias, congestive heart failure, recent myocardial infarction, or ECG abnormalities
- Gastrointestinal conditions affecting absorption or function including malabsorption syndrome, bowel resections, ulcerative colitis, inflammatory bowel disease, or bowel obstruction
- History of recent stem cell transplant or CAR-T therapy within 60 days or with active graft versus host disease or ongoing immunosuppressive therapy
- Grade 2 or higher toxicity continuing from prior anticancer therapy except alopecia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants receive oral TT-01488 tablets once daily in 28-day cycles as part of dose escalation to determine the recommended dose, followed by dose expansion to verify safety and preliminary efficacy.
Daily dosing with visits aligned to 28-day treatment cycles
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
S
Sun Caixia, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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