Evaluating TQB2029 injection for treating multiple myeloma

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

This study is testing a new injection called TQB2029 to see how safe it is and if it can help adults with multiple myeloma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06700395 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the maximum tolerated dose and safety of TQB2029 injection in adult patients with multiple myeloma. It consists of two phases: Phase Ia focuses on dose escalation to determine safety and tolerability, while Phase Ib evaluates the effectiveness of the treatment. Participants will be monitored for adverse events and pharmacokinetic parameters to understand the drug's impact on the disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of multiple myeloma and measurable lesions.

Not a fit: Patients who have recently undergone targeted therapy or immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with multiple myeloma.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in evaluating new treatments for multiple myeloma.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Zhongshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• West China hospital, Sichuan university — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Ting Niu, Doctor

Conditions Multiple Myeloma