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

NCT ID: NCT06700395

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2028-03-31

Brief 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2029 injection

TQB2029 injection, 28 days as a treatment cycle.

Group Type: EXPERIMENTAL

TQB2029 injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• The function of main organs is normal.
• Subjects need to adopt effective methods of contraception.

Exclusion Criteria

• 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
• Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment
• Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication
• Subjects who have experienced arterial/venous thrombotic event occurred within 6 months prior to the first administration
• Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders;
• Subjects with any severe and/or uncontrolled disease
• According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

West China hospital, Sichuan university

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Niu, Doctor

Role: CONTACT

Phone: 028-85423046

Email: tingniu@sina.com

Peng Liu, Doctor

Role: CONTACT

Phone: 021-60267405

Email: Liu.peng@zs-hospital.sh.cn

Facility Contacts

Peng Liu, Doctor

Role: primary

Ting Niu, Doctor

Role: primary

Other Identifiers

TQB2029-I-01

Identifier Type: -

Identifier Source: org_study_id