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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients (NCT07266116) is a Phase 1 / Phase 2 interventional studying Systemic Light Chain Amyloidosis, sponsored by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Systemic Light Chain Amyloidosis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 70 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Systemic Light Chain Amyloidosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - The subjects voluntarily joined this study, signed the willing to sign a consent form form, and exhibited good compliance; - Aged 18 to 75 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 have experienced disease recurrence or progression after the last line of treatment was ineffective or the duration of response to the last line of treatment was less than 12 months; - 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 Should NOT Join This Trial: - Diagnosed with other types of amyloidosis, active plasma cell leukemia, 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance; * Aged 18 to 75 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 have experienced disease recurrence or progression after the last line of treatment was ineffective or the duration of response to the last line of treatment was less than 12 months; * 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, 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; * 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; * Have had asthma within 2 years before the first medication or currently suffer from asthma; * Individuals with significant cardiovascular diseases; * Individuals with a history of immune deficiency, or active autoimmune diseases requiring systemic immunosuppressive therapy, etc * Subjects deemed unsuitable for enrollment by the researchers.

Treatments Being Tested

DRUG

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.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China
Peking University ShenZhen Hospital
Shenzhen, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Anyang People's Hospital
Anyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The first hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Qingdao municipal hosptial (group)
Qingdao, Shandong, China
Renji Hospital Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07266116), the sponsor (Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07266116 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07266116?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07266116?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07266116. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07266116. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.