Actively Recruiting
A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-08-11
114
Participants Needed
3
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
TQB2101 for Injection is an Antibody-Drug Conjugate (ADC) targeting Receptor Tyrosine Kinase Like Orphan Receptor 1 (ROR1).It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.
CONDITIONS
Official Title
A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate and sign informed consent with good compliance
- Age between 18 and 75 years
- ECOG performance status score of 0-1
- Expected survival longer than 12 weeks
- Advanced hematologic malignancies confirmed by cytology/histopathology with failed standard treatment or no effective options
- At least one measurable lesion per 2014 Lugano criteria
- Adequate organ function meeting specific blood and liver function criteria
- Women of childbearing potential and male subjects agree to use effective contraception during and 6 months after the study
- Negative blood pregnancy test within 7 days prior to enrollment for women of childbearing potential
You will not qualify if you...
- Other malignant tumors within 3 years except certain cured cancers
- Lymphoma involving or suspected in the central nervous system
- Recent chemotherapy, immunotherapy, radiotherapy, or targeted drugs within specified washout periods
- Recent treatment with specific traditional Chinese medicines with anti-tumor effects
- Previous treatment with ROR1 inhibitor drugs
- Participation in other anti-tumor drug trials within 4 weeks before administration
- Unrecovered adverse reactions from previous treatments above grade 1 (with some exceptions)
- Recent major surgery, trauma, or unhealed wounds
- Significant bleeding events or coagulation disorders
- Recent arterial or venous thrombotic events
- Decompensated liver cirrhosis or active hepatitis B or C infection
- Active syphilis or pulmonary tuberculosis
- History of substance abuse or mental disorders
- Clinically significant cardiovascular diseases including recent heart attack or severe heart failure
- Active or uncontrolled severe infections
- Renal failure requiring dialysis
- History of immunodeficiency including HIV
- Active pneumonia or interstitial lung disease requiring treatment
- History or current central nervous system diseases
- Significant proteinuria or poorly controlled diabetes
- Uncontrolled fluid accumulation requiring drainage
- Known allergy to study drug excipients
- Any condition judged by investigator to risk safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
2
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
3
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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