TQB2934 injection for systemic light chain amyloidosis

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 trial will test whether a subcutaneous injection of TQB2934 is safe and can improve blood response in adults with relapsed or refractory systemic light chain amyloidosis who have had daratumumab and bortezomib.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation, daratumumab
• Locations: 27 sites (Beijing, Beijing Municipality and 26 other locations)
• Trial ID: NCT07266116 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 program gives subcutaneous TQB2934 to adults with systemic light chain (AL) amyloidosis in a dose-finding Phase 1b portion followed by a Phase 2 expansion. Phase 1b (13–21 subjects) will characterize safety, pharmacokinetics, pharmacodynamics, immunogenicity, and determine a recommended Phase 2 dose. Phase 2 plans to enroll about 49 subjects with relapsed/refractory disease previously treated with daratumumab and bortezomib to see if the hematologic complete response rate is higher than historical controls. The primary endpoint is hematologic complete response rate and the total planned enrollment is approximately 70 subjects.

Who should consider this trial

Good fit: Adults aged 18–80 with systemic light chain amyloidosis, measurable disease, at least one organ involved, ECOG 0–2, expected survival >12 weeks, NT-proBNP ≤8500 ng/L, and prior treatment including daratumumab and bortezomib are the intended participants.

Not a fit: Patients with very advanced organ failure, inadequate organ function per protocol, or those who have not received prior daratumumab and bortezomib are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, TQB2934 could increase the hematologic complete response rate and improve disease control for patients with relapsed/refractory AL amyloidosis.

How similar studies have performed: Antibody-based therapies such as daratumumab have improved responses in AL amyloidosis, but TQB2934 is a novel agent and has not yet been proven in large clinical trials.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 26 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Southwest Hospital, Third Military Medical University (Army Medical University) — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guangzhou First Municipal People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Peking University ShenZhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Anyang People's Hospital — Anyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• The second Affiliated hospital of dalian medical university — Dalian, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Qingdao municipal hosptial (group) — Qingdao, Shandong, China (Not_yet_recruiting)
• Renji Hospital Shanghai Jiaotong University School Of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Chinese Academy of Medical Sciences Hematology Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jin Lu, Doctor

Conditions Systemic Light Chain Amyloidosis