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

NCT07266116 | Recruiting Phase 1

• 1 other identifier: TQB2934-Ib/II-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Systemic Light Chain Amyloidosis

Outcome Measures

Primary Outcomes (2)

• Numbers of subjects with adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs)

  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)

  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 Outcomes (14)

• Peak concentration (Cmax)

  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

  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

  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

  Baseline to CR, about 1.5 years

• Best overall hematologic response rate

  Baseline to CR/VGPR/PR, about 1.5 years

Study Arms (1)

TQB2934 injection

EXPERIMENTAL

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

Interventions

TQB2934 injection DRUG

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.

TQB2934 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (23)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Southwest Hospital, Third Military Medical University (Army Medical University)

Chongqing, Chongqing Municipality, 400038, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 362011, China

NOT YET RECRUITING

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

NOT YET RECRUITING

Peking University ShenZhen Hospital

Shenzhen, Guangdong, 518036, China

NOT YET RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

NOT YET RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, 050031, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

Anyang People's Hospital

Anyang, Henan, 455000, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 212028, China

NOT YET RECRUITING

The first hospital of Jilin University

Changchun, Jilin, 130031, China

NOT YET RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 11004, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Qingdao municipal hosptial (group)

Qingdao, Shandong, 266001, China

NOT YET RECRUITING

Renji Hospital Shanghai Jiaotong University School Of Medicine

Shanghai, Shanghai Municipality, 200001, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

NOT YET RECRUITING

Chinese Academy of Medical Sciences Hematology Hospital

Tianjin, Tianjin Municipality, 301617, China

NOT YET RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310018, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310018, China

NOT YET RECRUITING

Central Study Contacts

Jin Lu, Doctor

CONTACT

13311491805; jinllu@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: December 26, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-09

Locations

CN (23)