NCT06700395 A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
| NCT ID | NCT06700395 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2024-11-28 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 136 participants in total. It began in 2024-11-28 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06700395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06700395 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06700395 currently recruiting?
Yes, NCT06700395 is actively recruiting participants. Contact the research team at tingniu@sina.com for enrollment information.
Where is the NCT06700395 trial being conducted?
This trial is being conducted at Shanghai, China, Chengdu, China.
Who is sponsoring the NCT06700395 clinical trial?
NCT06700395 is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. The trial plans to enroll 136 participants.