Actively Recruiting
Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2026-05-08
70
Participants Needed
27
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a clinical trial aimed at the marketing of TQB2934 for injection. The project plans to enroll 70 subjects, including 13-21 subjects in Phase Ib, to evaluate the safety and preliminary efficacy, pharmacokinetic (PK) characteristics, immunogenicity, and pharmacodynamic (PD) of TQB2934 for injection in subjects with systemic light chain amyloidosis, and to determine the recommended Phase II dose (RP2D). The Phase II plan involves enrolling 49 subjects, aiming to demonstrate that in adult subjects with relapsed/refractory systemic light chain amyloidosis who have previously received treatment with daratumumab and bortezomib, TQB2934 for injection significantly improves the hematological complete response (CR) rate compared to historical controls. The primary endpoint is the optimal hematological CR rate.
CONDITIONS
Official Title
Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent with good compliance
- Aged 18 to 80 years with ECOG score 0 to 2 and expected survival over 12 weeks
- Diagnosed with systemic light chain amyloidosis
- Has measurable lesions
- Has involvement of at least one organ
- Previously received at least one line of systemic treatment and relapsed or progressed after remission
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) 8500 ng/L
- Organ function meets protocol requirements
- Women of childbearing potential agree to contraception during and for 6 months after study, have negative pregnancy test within 7 days before enrollment, and are not breastfeeding
- Men agree to contraception during and for 6 months after study
You will not qualify if you...
- Diagnosed with other types of amyloidosis, active plasma cell leukemia, or active multiple myeloma
- Received allogeneic hematopoietic stem cell transplant within 1 year or autologous stem cell transplant within 12 weeks before first dose
- Previously treated with drugs targeting the same target as TQB2934
- Received high doses of dexamethasone, targeted therapy, cytotoxic drugs, antibody therapy, proteasome inhibitors, radiotherapy, or immunomodulators within specified weeks before first dose
- Received traditional Chinese patent medicines with anti-tumor indications within 2 weeks before first dose
- Received attenuated live vaccine within 4 weeks before first dose or plans to during study
- History of severe allergies to monoclonal antibodies, human immunoglobulins, or study drug components
- History or current other malignant tumors within 3 years before first dose
- Unresolved toxic reactions above Grade 1 from previous treatment
- Recent major surgery or significant injury within 4 weeks before first dose
- Arterial/venous thromboembolic events within 6 months before first dose
- History of psychotropic drug abuse, mental disorders, or intractable seizures requiring treatment
- Poor blood pressure control or poorly controlled diabetes
- Active or uncontrolled severe infections within 4 weeks before first dose
- Hepatitis or decompensated liver cirrhosis (Child-Pugh B or C)
- Active tuberculosis or certain lung diseases including recent or active pneumonia
- Asthma within 2 years before first dose or current asthma or COPD
- Significant cardiovascular diseases
- History of immune deficiency or active autoimmune diseases needing systemic immunosuppressive therapy
- Organ failure not related to systemic light-chain amyloidosis
- Deemed unsuitable for enrollment by researchers
AI-Screening
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Trial Site Locations
Total: 27 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, China, 400038
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 362011
Not Yet Recruiting
5
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
6
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510180
Not Yet Recruiting
7
Peking University ShenZhen Hospital
Shenzhen, Guangdong, China, 518036
Not Yet Recruiting
8
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Not Yet Recruiting
9
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 050031
Not Yet Recruiting
10
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
11
Anyang People's Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
12
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
13
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 212028
Not Yet Recruiting
14
The first hospital of Jilin University
Changchun, Jilin, China, 130031
Not Yet Recruiting
15
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130033
Not Yet Recruiting
16
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130033
Not Yet Recruiting
17
The second Affiliated hospital of dalian medical university
Dalian, Liaoning, China, 116021
Not Yet Recruiting
18
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 11004
Not Yet Recruiting
19
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
20
Qingdao municipal hosptial (group)
Qingdao, Shandong, China, 266001
Not Yet Recruiting
21
Renji Hospital Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200001
Not Yet Recruiting
22
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
23
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, China, 301617
Not Yet Recruiting
24
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
25
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310018
Not Yet Recruiting
26
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310018
Not Yet Recruiting
27
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310018
Not Yet Recruiting
Research Team
J
Jin Lu, 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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