Recombinant Humanized Anti-BCMA/CD3 Bispecific… · relapsed/refractory multiple myeloma Phase II clinical trial
Official protocol title:An Open-Label, Multicenter Phase II Clinical Study Evaluating the Efficacy and Safety of F182112 in Combination with Different Dosing Regimens for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase II clinical trial sponsored by Shandong New Time Pharmaceutical Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM). Participants must have received at least 1–3 prior lines of anti-myeloma therapy (certain cohorts explicitly require that prior treatment regimens must have contained a proteasome inhibitor and at least 2 consecutive cycles of lenalidomide, and participants must be pomalidomide-naive or intolerant to pomalidomide). The treatment regimen primarily utilizes a bispecific antibody drug (recombinant humanized anti-BCMA/CD3 bispecific antibody for injection F182112), with a dosing schedule of once weekly. The trial is conducted across a total of 45 top domestic hospitals in China, including the Tianjin Institute of Hematology (Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences), Nanfang Hospital of Southern Medical University, Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Sichuan Provincial People's Hospital, and The First Affiliated Hospital of Zhengzhou University.
Participating Centers2 in China + 42 overseas
Source and Verification
Every fact on this page is derived from the official study protocol document below. The source document is archived as a PDF for direct verification.
- Document type
- CDE clinical trial registration filing (original PDF)
- Official registration number
- CTR20250778
- Verify on the NMPA CDE public platformby entering CTR20250778 in the registration-number field. The platform is a search interface with no permanent per-study URL, so a direct link is not possible.
- Last reconciled
- 2026-09-07
Frequently Asked Questions about this Study
Structured facts derived from official protocol filings for patient and family reference
According to official protocol filings (target population synthesized by CMDN from study details, not an official CDE field), this study is primarily designed for patients with [Relapsed/refractory]. Eligibility requires verified clinical confirmation by investigators regarding prior lines of therapy, active disease biomarkers, and performance status.
According to verified protocol filings, key eligibility thresholds include: age ≥ 18 years, ECOG performance status ≤ 2, ≥ 1 prior lines of therapy. The study specifies 9 inclusion and 21 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.
The core therapeutic target or investigational mechanism is [Recombinant Humanized Anti-BCMA/CD3 Bispecific Antibody for Injection]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.
This study is registered as a [Phase II] clinical trial. The protocol is conducted under rigorous ethical and Good Clinical Practice (GCP) oversight approved by institutional ethics committees.
This is an international multi-centre study with 2 study centres in China and 42 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Bengbu Medical University, The First Affiliated Hospital of Chongqing Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20250778] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.
Key Information
Status
Recruiting
Phase
Phase II
Target / Therapy
Recombinant Humanized Anti-BCMA/CD3 Bispecific Antibody for Injection
Sponsor
Shandong New Time Pharmaceutical Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
2 in China + 42 overseas
CDE Registry ID
CTR20250778
ClinicalTrials.gov ID
NCT07312188Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
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Protocol drugs and related tests are fully covered by the sponsor. All studies are strictly supervised by ethics committees, and patients retain the legal right to withdraw at any time.
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