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Tests treatment safety and results for Systemic Light Chain Amyloidosis
Official title Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients
ClinicalTrials.gov ID: NCT07266116
What this study is testing
What is TQB2934 injection?
TQB2934 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for systemic light chain amyloidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- The people 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;
You likely can't join if
- 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...
- 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...
- Those who have received treatment with traditional Chinese patent medicines and simple preparations with clear anti-tumor indications specified in...
- Those who have received attenuated live vaccine within 4 weeks before the first dose or plan to receive attenuated live vaccine during the study...
See the full eligibility criteria
- The people 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...
- 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...
- 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...
- 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...
- 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 people with organ failure unrelated to systemic light-chain (AL) amyloidosis;
- people deemed unsuitable for enrollment by the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Guiyang, Guizhou, China
- Baoding, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Qingdao, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Guiyang, Guizhou, China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.