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RECRUITING
NCT06700395
PHASE1

A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma

Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2024-11-28

Completion Date

2028-03

Last Updated

2024-12-06

Healthy Volunteers

No

Interventions

DRUG

TQB2029 injection

TQB2029 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.

Locations (2)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

West China hospital, Sichuan university

Chengdu, Sichuan, China