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

May 7, 2026 updated by: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100034
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Not yet recruiting
        • Southwest Hospital, Third Military Medical University (Army Medical University)
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 362011
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510180
        • Not yet recruiting
        • Guangzhou First Municipal People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518036
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 050031
        • Not yet recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • Anyang People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 212028
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130033
        • Not yet recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130031
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116021
        • Not yet recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
      • Shenyang, Liaoning, China, 11004
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266001
        • Not yet recruiting
        • Qingdao municipal hosptial (group)
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Not yet recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 301617
        • Not yet recruiting
        • Chinese Academy of Medical Sciences Hematology Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Not yet recruiting
        • Hangzhou First People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310018
        • Not yet recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310018
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2934 injection
TQB2934 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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).
Baseline to the end of the study, about 4 years
The best hematological response evaluated by the Independent Review Committee (IRC) is complete remission (CR)
Time Frame: Baseline to CR，about 1.5 years
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.
Baseline to CR，about 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak concentration (Cmax)
Time Frame: 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
Maximum plasma drug concentration.
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
Immunogenicity incidence rate and its changes over time
Time Frame: pre-dose day 8, cycle 2 day 1, cycle 6 day 1, cycle 12 day 1 and End of Treatment (EOT)
Immunogenicity incidence rate and its changes over time
pre-dose day 8, cycle 2 day 1, cycle 6 day 1, cycle 12 day 1 and End of Treatment (EOT)
Exploring the correlation between soluble BCMA in peripheral blood and the efficacy of TQB2934
Time Frame: 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
Exploring the correlation between soluble BCMA in peripheral blood and the efficacy of TQB2934
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
The best hematologic complete remission rate evaluated by researchers
Time Frame: Baseline to CR, about 1.5 years
The percentage of subjects with complete remission, which is the best hematological response evaluated by researchers.
Baseline to CR, about 1.5 years
Best overall hematologic response rate
Time Frame: Baseline to CR/VGPR/PR, about 1.5 years
Percentage of subjects with best hematologic response of complete remission (CR), very good partial remission (VGPR), and partial remission (PR)
Baseline to CR/VGPR/PR, about 1.5 years
Minimal residual disease (MRD) negative rate
Time Frame: Baseline to MRD negativity, about 1.5 years
Percentage of subjects achieving MRD negativity.
Baseline to MRD negativity, about 1.5 years
Duration of hematologic response (DOR)
Time Frame: The first date of PR/ VGPR/ CR to PD/ major organ failure /die, about 1.5 years
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).
The first date of PR/ VGPR/ CR to PD/ major organ failure /die, about 1.5 years
Duration of complete hematological remission (DOCR)
Time Frame: The first date of CR to PD/ major organ failure /die, about 1.5 years
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).
The first date of CR to PD/ major organ failure /die, about 1.5 years
Cardiac relief rate
Time Frame: Baseline to Cardiac relief, about 1.5 years
Percentage of subjects who achieve cardiac remission according to the International Society for Transfusion Medicine (ISA) criteria.
Baseline to Cardiac relief, about 1.5 years
Renal remission rate
Time Frame: Baseline to Renal remission, about 1.5 years
Percentage of subjects achieving renal remission according to International Society of Amyloidosis (ISA) criteria.
Baseline to Renal remission, about 1.5 years
Liver response rate
Time Frame: Baseline to liver remission, about 1.5 years
Percentage of subjects achieving liver remission according to the International Society of Transfusion Medicine (ISA) criteria.
Baseline to liver remission, about 1.5 years
Main organ dysfunction progression-free survival (MOD-PFS)
Time Frame: The first date of initial medication to PD/ major organ failure /die, about 2 years
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).
The first date of initial medication to PD/ major organ failure /die, about 2 years
Major Organ Dysfunction-Event-Free Survival (MOD-EFS)
Time Frame: The first date of initial medication to PD/ major organ failure /die, about 2 years
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).
The first date of initial medication to PD/ major organ failure /die, about 2 years
Overall survival (OS)
Time Frame: The first date of initial medication to die, about 2 years
The time from the date of initial medication to the date of death from any cause
The first date of initial medication to die, about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TQB2934-Ib/II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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