ClinicalTrials.gov record NCT07266116

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 80 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase Ib/II interventional study will test TQB2934, a bispecific antibody given by subcutaneous injection, in people with systemic light chain (AL) amyloidosis. The study plans about 70 participants (13–21 in Phase Ib; ~49 in Phase II) to find a recommended Phase II dose and to evaluate safety, drug behavior in the body, immune response to the drug, and hematologic responses. Phase II specifically evaluates hematologic complete remission rate after TQB2934 in adults with relapsed/refractory AL amyloidosis who previously received daratumumab and bortezomib, compared with historical controls.

What it is studying. The study is testing TQB2934 given by subcutaneous injection. It will evaluate safety and side effects, how the drug is handled in the body (pharmacokinetics), whether the body mounts an immune response to the drug (immunogenicity), pharmacodynamic signals, and hematologic outcomes including complete remission rates.

What the researchers hope to learn. To determine a recommended Phase II dose (RP2D) and to describe the safety profile of TQB2934. To measure pharmacokinetics, immunogenicity, and pharmacodynamic markers. To assess hematologic response rates (including complete remission) and explore relationships between soluble BCMA and treatment effect.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • TQB2934 injection

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive subcutaneous TQB2934 injections on a set schedule (weekly in cycles 1–3, every two weeks in cycles 4–6, then every eight weeks if not in complete remission or MRD positive), for a maximum of up to two years. They will have repeated clinic visits for safety monitoring and disease assessments, and provide blood samples for drug levels (pharmacokinetics), immunogenicity testing, and measurements such as soluble BCMA; the study will also assess hematologic response, organ responses, and minimal residual disease (MRD) per study procedures. Visits will include exams and laboratory testing as required by the study team; exact tests and timing will be explained by study staff. Women must have a negative pregnancy test before enrollment and both sexes must follow the contraception requirements described above.

How the study is structured. Open-label, single-group Phase Ib/II trial. Participants receive TQB2934 injections (doses include 40 mg and 60 mg as described) on a schedule that is weekly during early cycles, then every two weeks, and — if criteria are met — every eight weeks thereafter, for up to two years. About 70 people are planned overall, with a small initial Phase Ib cohort to evaluate safety and dose, then a larger Phase II cohort to assess hematologic response rates. The study does not use masking or randomization.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Dec 26, 2025
Primary completion
February 2029 (estimated)
Study completion
November 2029 (estimated)
Target enrollment
70 participants (estimated)
Last updated on registry
May 8, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (27)

  • Peking University First HospitalNot Yet Recruiting

    Beijing, Beijing Municipality, 100034 · China

  • Peking University People's HospitalRecruiting

    Beijing, Beijing Municipality, 100044 · China

  • Southwest Hospital, Third Military Medical University (Army Medical University)Not Yet Recruiting

    Chongqing, Chongqing Municipality, 400038 · China

  • Fujian Medical University Union HospitalNot Yet Recruiting

    Fuzhou, Fujian, 362011 · China

  • The First Affiliated Hospital, Sun Yat-sen UniversityNot Yet Recruiting

    Guangzhou, Guangdong, 510080 · China

  • Guangzhou First Municipal People's HospitalNot Yet Recruiting

    Guangzhou, Guangdong, 510180 · China

  • Peking University ShenZhen HospitalNot Yet Recruiting

    Shenzhen, Guangdong, 518036 · China

  • The Affiliated Hospital of Guizhou Medical UniversityNot Yet Recruiting

    Guiyang, Guizhou, 550004 · China

  • Affiliated Hospital of Hebei UniversityNot Yet Recruiting

    Baoding, Hebei, 050031 · China

  • The First Affiliated Hospital of Harbin Medical UniversityNot Yet Recruiting

    Harbin, Heilongjiang, 150000 · China

Terms used on this page · explanations by MedicalUpdates.ai

pharmacokinetic
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamic
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
Phase II
A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
RP2D
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
complete response
No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
glucocorticoids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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