Actively Recruiting
Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of TQB2029 for Injection in Adults With Multiple Myeloma
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2024-12-06
136
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQB2029 for injection in adults with multiple myeloma to determine the maximum tolerated dose, dose-limiting toxicities, adverse events, pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor effects. The study includes a Phase Ia dose escalation period to assess safety and tolerability, followed by a Phase Ib dose extension period to evaluate treatment effectiveness. Participants receive TQB2029 injections in 28-day treatment cycles. The study monitors drug levels and immune response markers at multiple time points during the first and second treatment cycles. Immunogenicity is assessed at specified cycles and at the end of treatment. The trial aims to identify the recommended dose for future research. During the study, participants undergo regular evaluations including measurement of drug concentration, immune system activity, and treatment response. Researchers track adverse events and clinical outcomes such as remission rates and survival over up to 18 months. Safety and tolerability are closely monitored throughout the treatment period.
CONDITIONS
Brief Title
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
- Aged from 18 to 75 years.
- Eastern Cooperative Oncology Group performance status score of 0 to 2.
- At least 12 weeks expected survival period.
- Diagnosed with multiple myeloma meeting International Myeloma Working Group diagnostic criteria.
- Presence of measurable lesions.
- Normal function of main organs.
- Use of effective contraception methods.
You will not qualify if you...
- Use of Chinese patent medicines with anti-tumor indications within 2 weeks before first administration.
- Targeted therapy or immunotherapy within 3 weeks before first medication.
- Known allergy to study medications, analogues, or excipients.
- History or current other malignant tumors within past 3 years.
- Unresolved toxic reactions above grade 1 from previous treatment.
- Major surgery, significant trauma, or planned major surgery within 4 weeks before first medication.
- Arterial or venous thrombotic event within 6 months before first administration.
- History of psychotropic drug abuse unable to quit or mental disorders.
- Severe or uncontrolled disease.
- Other serious accompanying diseases affecting safety or study completion per investigator judgment.
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.
1 visit (in-person)
Duration - Repeated 28-day cycles for up to 18 months
Participants receive TQB2029 injection as treatment cycles lasting 28 days each to evaluate safety, tolerability, and pharmacokinetics.
Frequent visits for drug dosing and pharmacokinetic sampling during the first two treatment cycles, including multiple visits on dosing days and scheduled follow-up visits
Duration - Up to 18 months
Participants are monitored for safety outcomes, therapeutic efficacy, and long-term response after treatment cycles.
Periodic visits for clinical assessments and laboratory tests
Trial Site Locations
Total: 2 locations
1
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
2
West China hospital, Sichuan university
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
T
Ting Niu, Doctor
P
Peng Liu, Doctor
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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