This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.
Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period.
Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria
There are measurable lesions present
Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication
Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication
Single group
TQB2029 injection
DrugTQB2029 for injection is a bispecific antibody targeting G Protein-Coupled Receptor, Class C, Group 5, Member D (GPRC5D) and Cluster of Differentiation 3 (CD3) . By recruiting and activating CD3 positive T cells, it induces T cells to kill malignant plasma cells expressing GPRC5D, thereby inhibiting the occurrence and development of tumors.
Dose Limiting Toxicities (DLT)
DLT refers to any of the following events in the first administration of TQB2029 for injection to the end of the first treatment cycle (C1D28) that the investigator and the sponsor consider to be related to the treatment of TQB2029 for injection.
Maximum tolerated dose (MTD)
After the experiment is completed, sequential regression is used to determine the maximum tolerated dose (MTD). Specifically, calculate the toxicity rate of each dose group and select the dose closest to the target toxicity rate as MTD.
Recommended Phase II Dose (RP2D)
Determine RP2D based on target toxicity rates for each dose group
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) v5.0.
Elimination half-life (to be used in one-or non- compartmental model) (t1/2)
t1/2 is time it takes for the blood concentration of TQB2029 or metabolite(s) to drop by half.
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB2029 or metabolite(s).
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB2029 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Apparent clearance rate (CL/F)
The apparent clearance rate is used to predict dynamic distribution rates and evaluate the dynamics of nutrients.
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