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Systemic Light Chain AmyloidosisPhase 1/2NCT07266116

Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients

A Phase 1/2 study testing TQB2934 injection in people with Systemic Light Chain Amyloidosis, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 27 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Systemic Light Chain Amyloidosis
What is being tested?
TQB2934 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
27 sitesChina
Study dates
26 Dec 2025to Nov 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance;
  • Aged 18 to 80 years old, with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, and an expected survival of more than 12 weeks;
  • Systemic light chain amyloidosis with diagnostic records (i.e., primary light chain amyloidosis);
  • Presence of measurable lesions;
  • At least one organ involved;
  • Have previously received at least one line of systemic treatment, and recurred and progressed after the remission of the last line treatment;
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  • N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≤ 8500 ng/L;
  • The corresponding organ function conforms to the protocol requirements;
  • Women of childbearing age should agree to use contraception during the study period and for 6 months after its completion; they must have a negative serum pregnancy test within 7 days before enrollment in the study and must be non-lactating subjects; men should agree to use contraception during the study period and for 6 months after its completion.

Who cannot join

  • Diagnosed with other types of amyloidosis, active plasma cell leukemia, active multiple myeloma, etc.
  • Have received allogeneic hematopoietic stem cell transplantation within 1 year prior to the first dose, or have received autologous hematopoietic stem cell transplantation within 12 weeks prior to the first dose;
  • Previously received treatment with drugs targeting the same target;
  • Within 4 weeks prior to the first dose, the patient has received a cumulative dose of dexamethasone >160 mg or an equivalent dose of other glucocorticoids, or within 3 weeks prior to the first dose, the patient has received targeted therapy, cytotoxic drugs, or any antibody therapy, or within 2 weeks prior to the first dose, the patient has received proteasome inhibitor therapy or radiotherapy, or within 1 week prior to the first dose, the patient has received immunomodulator therapy;
  • Those who have received treatment with traditional Chinese patent medicines and simple preparations with clear anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the first administration;
  • Those who have received attenuated live vaccine within 4 weeks before the first dose or plan to receive attenuated live vaccine during the study period;
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  • Individuals with a history of severe allergies of unknown cause, or known allergies to monoclonal antibody drugs or exogenous human immunoglobulins, or known allergies to the excipients in injectable TQB2934 or pharmaceutical preparations;
  • Having had or currently suffering from other malignant tumors within 3 years before the first medication;
  • Unresolved toxic reactions above Common Terminology Criteria (CTC) AE Grade 1 caused by any previous treatment;
  • Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period within 4 weeks before the first dose of medication;
  • Arterial/venous thromboembolic events occurred within 6 months before the first dose;
  • Individuals with a history of abuse of psychotropic drugs who are unable to quit or who have mental disorders; or intractable seizures that require treatment;
  • Those with unsatisfactory blood pressure control;
  • Patients with poorly controlled diabetes;
  • Patients who have active or uncontrolled severe bacterial, viral, or systemic fungal infections (≥CTC AE Grade 2 infections) within 4 weeks before the first dose of medication;
  • Patients with hepatitis or decompensated liver cirrhosis (Child-Pugh Class B or C);
  • Individuals with active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or clinically symptomatic active pneumonia;
  • Those who have experienced asthma within 2 years before the first medication or currently suffer from asthma or chronic obstructive pulmonary disease;
  • Individuals with significant cardiovascular diseases;
  • Individuals with a history of immune deficiency, or active autoimmune diseases requiring systemic immunosuppressive therapy, etc.
  • Exclude subjects with organ failure unrelated to systemic light-chain (AL) amyloidosis;
  • Subjects deemed unsuitable for enrollment by the researchers.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Lu, Doctor contact

13311491805

jinllu@sina.com

27 sites in 1 country

China27 sites, 27 recruiting

  • Anyang People's Hospital

    Anyang, Henan, 455000

    Zhengrong Liu, Master, 16637233130, 16637233130@163.com

    Not yet recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 050031

    Hua Xue, Doctor, 15031273319, xh-xuehua@163.com

    Not yet recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    MingHui Zhao, Doctor, 13501243815, mhzhao@bjmu.edu.cn

    Not yet recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Jin Lu, Doctor, 13311491805, jin1lu@sina.com

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130031

    Fengyan Jin, Doctor, 13504477141, jfy8181@163.com

    Not yet recruiting

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

    Linlin Liu, Doctor, 13943117770, liulinl@jlu.edu.cn

    Not yet recruiting

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

    Lintao Bi, Doctor, 13074370864, bilt@jlu.edu.cn

    Not yet recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

    Xiaobing Huang, Doctor, 189 8183 8236, hxb_trial@163.com

    Not yet recruiting

  • Southwest Hospital, Third Military Medical University (Army Medical University)

    Chongqing, Chongqing Municipality, 400038

    ShangNian Xu, Doctor, 13650596553, xushuangnian1985@163.com

    Not yet recruiting

  • The second Affiliated hospital of dalian medical university

    Dalian, Liaoning, 116021

    Xiaobo Wang, Doctor, 17709871007, dlwangxiaobo@163.com

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 362011

    Zhenshu Xu, Doctor, 13365910706, xuzs@fjmu.edu.cn

    Not yet recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Juan Li, Doctor, 13719209240, ljuan@mai.sysu.edu.cn

    Not yet recruiting

  • Guangzhou First Municipal People's Hospital

    Guangzhou, Guangdong, 510180

    Shunqing Wang, Doctor, 13437807998, drwangshq@medmail.cn

    Not yet recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

    Yan Zhang, Master, 18984155172, Zhangyan20010802@sina.com

    Not yet recruiting

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

    Xiangming Tong, Doctor, 13750816623, hzsyyy1@163.com

    Not yet recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310018

    Jin Zhang, Master, 135 8870 6767, zj3703@163.com

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310018

    Fei Han, Doctor, 0571-87236996, hanf8876@zju.edu.cn

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310018

    Jian Liu, Master, 0571-87236560, lindaliu87@zju.edu.cn

    Not yet recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    ShengJin Fan, Doctor, 13304641978, fansj1129@163.com

    Not yet recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 212028

    Xiaoyan Qu, Doctor, 13851746819, huijuanmao@126.com

    Not yet recruiting

  • Qingdao municipal hosptial (group)

    Qingdao, Shandong, 266001

    Yuping Zhong, Doctor, 17669757939, zhongyp3352@126.com

    Not yet recruiting

  • Renji Hospital Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai Municipality, 200001

    Juan Du, Doctor, 158 0070 6091, juan_du@live.com

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 11004

    Aijun Liao, Doctor, 18940259833, liaoaijun@sina.com

    Not yet recruiting

  • Peking University ShenZhen Hospital

    Shenzhen, Guangdong, 518036

    Jia Feng, 13500059382, fengjia2013@163.com

    Not yet recruiting

  • Chinese Academy of Medical Sciences Hematology Hospital

    Tianjin, Tianjin Municipality, 301617

    Bo Jiang, Doctor, 18630810181, jiangbo@ihcams.as.cn

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi, 710000

    PengCheng He, Doctor, 18991232609, hpec_gcp@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Fang Wang, Master, 13663807908, fccwangf1@zzu.edu.cn

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQB2934 for Injection in Subjects With Systemic Light Chain Amyloidosis

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.

Being tested
TQB2934 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2934 injectionDrug

    TQB2934 for injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3). One end binds to the CD3 receptor on the surface of T cells, while the other end binds to BCMA, recruiting T cells to BCMA-positive cells. This can activate T cells, which then release granzyme, perforin, and other enzymes to kill BCMA-positive malignant plasma cells, thereby reducing the level of monoclonal immunoglobulin light chains in the body and delaying further organ damage.

Study groups in NCT07266116
Study groupRoleWhat they receive
TQB2934 injectionExperimentalTQB2934 injection 40 mg and 60 mg During cycles 1-3, medication is administered once a week. From the end of cycles 4-6, medication is administered once every two weeks. For patients who have not achieved complete remission (CR) or have MRD positivity after six cycles of medication, medication is administered once every eight weeks, with a maximum treatment duration of no more than two years
Receives: Drug: TQB2934 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numbers of subjects with adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs)

    The occurrence of all adverse events (AEs), serious adverse events (SAEs), incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs).

    Measured: Baseline to the end of the study, about 4 years

  2. The best hematological response evaluated by the Independent Review Committee (IRC) is complete remission (CR)

    Percentage of subjects who achieved complete hematological remission (CR) after receiving TQB2934 for injection among adult subjects with relapsed/refractory systemic light chain amyloidosis who had previously received treatment with duramycin and bortezomib.

    Measured: Baseline to CR，about 1.5 years

Secondary outcomes (14)

  1. Peak concentration (Cmax)

    Maximum plasma drug concentration.

    Measured: Pre-dose Cycle 1 day 1/day 8, post dose Cycle 1 day 8/Cycle 3 day 1 2, 6, 24, 48, 72, 120 hours; pre-dose cycle 1 day 15, 22,cycle 2 day 1, cycle 4 day 1, cycle 6 day 1, cycle 12 day 1 and EOT

  2. Immunogenicity incidence rate and its changes over time

    Immunogenicity incidence rate and its changes over time

    Measured: pre-dose day 8, cycle 2 day 1, cycle 6 day 1, cycle 12 day 1 and End of Treatment (EOT)

  3. Exploring the correlation between soluble BCMA in peripheral blood and the efficacy of TQB2934

    Exploring the correlation between soluble BCMA in peripheral blood and the efficacy of TQB2934

    Measured: pre-dose cycle 1 day 1, day 8, cycle 2 day 1, cycle 3 day 1, cycle 6 day 1, cycle 12 day 1; post dose cycle 1 day 1/day 8/cycle 3 day 1 6 hours; 56 days after the last administration

  4. The best hematologic complete remission rate evaluated by researchers

    The percentage of subjects with complete remission, which is the best hematological response evaluated by researchers.

    Measured: Baseline to CR, about 1.5 years

  5. Best overall hematologic response rate

    Percentage of subjects with best hematologic response of complete remission (CR), very good partial remission (VGPR), and partial remission (PR)

    Measured: Baseline to CR/VGPR/PR, about 1.5 years

  6. Minimal residual disease (MRD) negative rate

    Percentage of subjects achieving MRD negativity.

    Measured: Baseline to MRD negativity, about 1.5 years

  7. Duration of hematologic response (DOR)

    Among subjects with the best hematological response of CR, VGPR, or PR, the time from the date of first achieving PR or higher response to the date of hematological progression, major organ (heart or kidney) failure, or death (from any cause).

    Measured: The first date of PR/ VGPR/ CR to PD/ major organ failure /die, about 1.5 years

  8. Duration of complete hematological remission (DOCR)

    Among subjects with the best hematological response of CR, the time from the date of first achieving CR to the date of hematological progression, major organ (heart or kidney) failure, or death (from any cause).

    Measured: The first date of CR to PD/ major organ failure /die, about 1.5 years

  9. Cardiac relief rate

    Percentage of subjects who achieve cardiac remission according to the International Society for Transfusion Medicine (ISA) criteria.

    Measured: Baseline to Cardiac relief, about 1.5 years

  10. Renal remission rate

    Percentage of subjects achieving renal remission according to International Society of Amyloidosis (ISA) criteria.

    Measured: Baseline to Renal remission, about 1.5 years

  11. Liver response rate

    Percentage of subjects achieving liver remission according to the International Society of Transfusion Medicine (ISA) criteria.

    Measured: Baseline to liver remission, about 1.5 years

  12. Main organ dysfunction progression-free survival (MOD-PFS)

    The time from the date of initial medication to the date of hematological progression, major organ (heart or kidney) failure, or death (from any cause).

    Measured: The first date of initial medication to PD/ major organ failure /die, about 2 years

  13. Major Organ Dysfunction-Event-Free Survival (MOD-EFS)

    The time period from the date of initial medication to the date of hematological progression, major organ (heart or kidney) failure, change of treatment regimen due to poor efficacy or intolerance to toxicity, or death (from any cause).

    Measured: The first date of initial medication to PD/ major organ failure /die, about 2 years

  14. Overall survival (OS)

    The time from the date of initial medication to the date of death from any cause

    Measured: The first date of initial medication to die, about 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start26 Dec 2025
  3. Primary completionFeb 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07266116
Sponsor's protocol ID
TQB2934-Ib/II-01
Status last verified
Sep 2025
First submitted
25 Nov 2025
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB2934 injection in people with Systemic Light Chain Amyloidosis, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 27 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Lu, Doctor (13311491805, jinllu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of subjects with adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs) (time frame: Baseline to the end of the study, about 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07266116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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