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Clinical Trials in China / NCT07266116
Recruiting Phase 1/2

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

NCT07266116 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Phase
Phase 1/2
Started
2025-12-26
Last updated
2026-05-08

Condition(s) studied

Systemic Light Chain Amyloidosis

Investigational drug(s) / intervention(s)

TQB2934 injection

TQB2934 injection: 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 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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; * 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.

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Not Yet Recruiting
Peking University People's Hospital Beijing Beijing Municipality Recruiting
Southwest Hospital, Third Military Medical University (Army Medical University) Chongqing Chongqing Municipality Not Yet Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Not Yet Recruiting
The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong Not Yet Recruiting
Guangzhou First Municipal People's Hospital Guangzhou Guangdong Not Yet Recruiting
Peking University ShenZhen Hospital Shenzhen Guangdong Not Yet Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Not Yet Recruiting
Affiliated Hospital of Hebei University Baoding Hebei Not Yet Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Not Yet Recruiting
Anyang People's Hospital Anyang Henan Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Not Yet Recruiting
The first hospital of Jilin University Changchun Jilin Not Yet Recruiting
China-Japan Union Hospital of Jilin University Changchun Jilin Not Yet Recruiting
China-Japan Union Hospital of Jilin University Changchun Jilin Not Yet Recruiting
The second Affiliated hospital of dalian medical university Dalian Liaoning Not Yet Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University Xi'an Shaanxi Not Yet Recruiting
Qingdao municipal hosptial (group) Qingdao Shandong Not Yet Recruiting
Renji Hospital Shanghai Jiaotong University School Of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Not Yet Recruiting
Chinese Academy of Medical Sciences Hematology Hospital Tianjin Tianjin Municipality Not Yet Recruiting
Hangzhou First People's Hospital Hangzhou Zhejiang Not Yet Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting

More Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07266116 on ClinicalTrials.gov ↗ ← All trials in China