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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Peking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGSouthwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
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).
Time frame: 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.
Time frame: Baseline to CR,about 1.5 years
Peak concentration (Cmax)
Maximum plasma drug concentration.
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
Immunogenicity incidence rate and its changes over time
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)
Exploring the correlation between soluble BCMA in peripheral blood and the efficacy of TQB2934
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
The best hematologic complete remission rate evaluated by researchers
The percentage of subjects with complete remission, which is the best hematological response evaluated by researchers.
Time frame: Baseline to CR, about 1.5 years
Best overall hematologic response rate
Percentage of subjects with best hematologic response of complete remission (CR), very good partial remission (VGPR), and partial remission (PR)
Time frame: Baseline to CR/VGPR/PR, about 1.5 years
Minimal residual disease (MRD) negative rate
Percentage of subjects achieving MRD negativity.
Time frame: Baseline to MRD negativity, about 1.5 years
Duration of hematologic response (DOR)
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).
Time frame: The first date of PR/ VGPR/ CR to PD/ major organ failure /die, about 1.5 years
Duration of complete hematological remission (DOCR)
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).
Time frame: The first date of CR to PD/ major organ failure /die, about 1.5 years
Cardiac relief rate
Percentage of subjects who achieve cardiac remission according to the International Society for Transfusion Medicine (ISA) criteria.
Time frame: Baseline to Cardiac relief, about 1.5 years
Renal remission rate
Percentage of subjects achieving renal remission according to International Society of Amyloidosis (ISA) criteria.
Time frame: Baseline to Renal remission, about 1.5 years
Liver response rate
Percentage of subjects achieving liver remission according to the International Society of Transfusion Medicine (ISA) criteria.
Time frame: Baseline to liver remission, about 1.5 years
Main organ dysfunction progression-free survival (MOD-PFS)
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).
Time frame: The first date of initial medication to PD/ major organ failure /die, about 2 years
Major Organ Dysfunction-Event-Free Survival (MOD-EFS)
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).
Time frame: The first date of initial medication to PD/ major organ failure /die, about 2 years
Overall survival (OS)
The time from the date of initial medication to the date of death from any cause
Time frame: The first date of initial medication to die, about 2 years
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGPeking University ShenZhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
NOT_YET_RECRUITINGAffiliated Hospital of Hebei University
Baoding, Hebei, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITING...and 17 more locations