Actively Recruiting
A Phase Ib/II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQB2934 for Injection in Subjects With Systemic Light Chain Amyloidosis
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2026-05-08
70
Participants Needed
27
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQB2934 for injection in adults with systemic light chain amyloidosis who have relapsed or refractory disease after treatment with daratumumab and bortezomib. This Phase Ib/II clinical trial aims to assess the safety, preliminary effectiveness, pharmacokinetics, immunogenicity, and pharmacodynamics of TQB2934, a bispecific antibody targeting BCMA and CD3, to determine the recommended Phase II dose and whether it improves the hematological complete response rate compared to historical data. Participants will receive TQB2934 injections at doses of 40 mg or 60 mg. During the first three treatment cycles, the drug is administered once weekly. From cycles four to six, dosing occurs once every two weeks. For patients without complete remission or with minimal residual disease positivity after six cycles, the medication is given once every eight weeks, with treatment lasting up to two years. The study includes both Phase Ib and Phase II components with a planned enrollment of about 70 subjects. Throughout the study, participants will undergo regular assessments for adverse events, laboratory tests, and hematological responses evaluated by an independent committee. The trial will monitor pharmacokinetic and immunogenicity markers at multiple time points and evaluate organ responses and survival outcomes over approximately two years. This comprehensive monitoring aims to gather safety data and measure the best hematological response and other clinical outcomes during the study period.
CONDITIONS
Brief 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...
- Subjects voluntarily agree to participate and provide informed consent
- Aged 18 to 80 years old with an ECOG score of 0 to 2
- Expected survival of more than 12 weeks
- Diagnosed with systemic light chain amyloidosis
- Presence of measurable lesions
- At least one organ involved
- Have received at least one prior systemic treatment and experienced relapse or progression
- NT-proBNP level less than or equal to 8500 ng/L
- Organ function meets study requirements
- Women of childbearing potential agree to use contraception during and for 6 months after the study and have a negative pregnancy test
- Men agree to use contraception during and for 6 months after the study
You will not qualify if you...
- Diagnosed with other amyloidosis types, active plasma cell leukemia, or active multiple myeloma
- Received allogeneic hematopoietic stem cell transplant within 1 year or autologous transplant within 12 weeks prior to first dose
- Previously treated with drugs targeting BCMA or CD3
- Recent high-dose dexamethasone, targeted therapy, cytotoxic drugs, antibody therapy, proteasome inhibitors, radiotherapy, or immunomodulators within specified timeframes before first dose
- Use of anti-tumor traditional Chinese medicines within 2 weeks before first dose
- Received attenuated live vaccine within 4 weeks before first dose or planned during study
- History of severe allergies to monoclonal antibodies, immunoglobulins, or study drug components
- History or current malignant tumors within 3 years
- Unresolved toxic reactions above Grade 1 from prior treatments
- Major surgery or significant injury within 4 weeks before first dose
- Arterial or venous thromboembolic events within 6 months before first dose
- History of psychotropic drug abuse, mental disorders, or uncontrolled seizures
- Poorly controlled blood pressure or diabetes
- Active or uncontrolled infections within 4 weeks before first dose
- Hepatitis or decompensated liver cirrhosis
- Active tuberculosis or clinically symptomatic pneumonia
- Asthma or chronic obstructive pulmonary disease within 2 years or currently
- Significant cardiovascular diseases
- History of immune deficiency or active autoimmune diseases requiring systemic immunosuppression
- Organ failure unrelated to systemic light chain amyloidosis
- Deemed unsuitable by researchers
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 - Up to 2 years
Participants receive TQB2934 injection as the study treatment. Medication is administered once a week during cycles 1 to 3, once every two weeks during cycles 4 to 6, and then once every eight weeks for those without complete remission or with MRD positivity, with a maximum treatment duration of up to two years.
Weekly visits for cycles 1-3, biweekly visits for cycles 4-6, then visits every eight weeks thereafter
Duration - Up to about 4 years
Participants are monitored for safety, efficacy, and long-term outcomes after treatment ends, including assessments of adverse events, hematologic response, organ function, and survival.
Periodic visits as scheduled for safety and efficacy assessments
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
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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