New antibody therapy aims to fight rare amyloidosis

NCT ID NCT07266116

Disease control Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new drug called TQB2934 for people with systemic light chain amyloidosis, a rare disease where abnormal proteins damage organs. The drug is a bispecific antibody that helps the immune system target and destroy harmful cells. The trial will enroll 70 adults who have not responded to prior treatments, to see if the drug can improve blood response rates and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TQB2934 (a bispecific antibody that helps immune cells target and kill harmful plasma cells)
What this could lead to: If it works, this could offer a new treatment option for people with light chain amyloidosis who have not responded to standard therapies.
What could go wrong: This is an early-phase trial with only 70 participants, so results may not apply to everyone. The drug could cause side effects like immune reactions or organ damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis primary systemic amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic light chain amyloidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

27 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital of Hebei University
NOT_YET_RECRUITING

Baoding, Hebei, 050031, China
Anyang People's Hospital
NOT_YET_RECRUITING

Anyang, Henan, 455000, China
China-Japan Union Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130033, China
China-Japan Union Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130033, China
Chinese Academy of Medical Sciences Hematology Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 301617, China
Fujian Medical University Union Hospital
NOT_YET_RECRUITING

Fuzhou, Fujian, 362011, China
Guangzhou First Municipal People's Hospital
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510180, China
Hangzhou First People's Hospital
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310006, China
Jiangsu Province Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 212028, China
Peking University First Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
RECRUITING

Beijing, Beijing Municipality, 100044, China
Peking University ShenZhen Hospital
NOT_YET_RECRUITING

Shenzhen, Guangdong, 518036, China
Qingdao municipal hosptial (group)
NOT_YET_RECRUITING

Qingdao, Shandong, 266001, China
Renji Hospital Shanghai Jiaotong University School Of Medicine
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200001, China
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING

Shenyang, Liaoning, 11004, China
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310018, China
Southwest Hospital, Third Military Medical University (Army Medical University)
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400038, China
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING

Guiyang, Guizhou, 550004, China
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710000, China
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, Henan, 450052, China
The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310018, China
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310018, China
The first hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130031, China
The second Affiliated hospital of dalian medical university
NOT_YET_RECRUITING

Dalian, Liaoning, 116021, China

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