Actively Recruiting
A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies
Led by TransThera Sciences (Nanjing), Inc. · Updated on 2023-11-21
37
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 with confirmed B-cell malignancy who have failed or are intolerant to at least two prior standard treatments or have received one prior BTK-containing treatment
- Patients with CLL/SLL treated with prior immunochemistry or BTK inhibitor-containing regimen
- Patients with DLBCL treated with prior CD20 or anthracycline-containing regimen
- Patients with other B-cell non-Hodgkin lymphoma treated with prior CD20-containing regimen
- Adequate organ function including:
- Absolute neutrophil count 0.75 x 10^9/L (or 0.5 x 10^9/L if bone marrow involved)
- Platelets 50 x 10^9/L without transfusion within 7 days (or 30 x 10^9/L if bone marrow involved)
- Hemoglobin 8.0 g/dL without transfusion within 7 days (or 7.0 g/dL if bone marrow involved)
- Prothrombin time 1.5 times upper limit of normal
- Activated partial thromboplastin time 1.5 times upper limit of normal
- Creatinine clearance 30 mL/min estimated by Cockcroft-Gault formula
- Total bilirubin 1.5 times upper limit of normal (unless due to Gilbert's disease)
- AST or ALT 2.5 times upper limit of normal unless disease-related
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer disease-free for at least 2 years or not limiting survival to less than 2 years
- Significant cardiovascular disease such as uncontrolled arrhythmias, congestive heart failure, recent myocardial infarction within 6 months, or significant ECG abnormalities
- Malabsorption syndrome, significant gastrointestinal disease, stomach or small bowel resection, ulcerative colitis, symptomatic inflammatory bowel disease, or bowel obstruction
- History of stem cell transplant or CAR-T therapy within past 60 days or with active graft versus host disease, incomplete blood count recovery, need for anti-cytokine therapy, residual neurotoxicity symptoms above Grade 1, or ongoing immunosuppressive therapy
- Grade 2 or higher toxicity continuing from prior anticancer therapy (except alopecia) including radiation
AI-Screening
AI-Powered Screening
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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
CONTACT
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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