T-cell redirecting bispecific antibody · relapsed/refractory multiple myeloma Phase Ib clinical trial
Official protocol title:A Phase Ib, Open-Label, Single-Arm, Multicenter Study Evaluating the Pharmacokinetics, Safety, and Efficacy of CEVOSTAMAB in Chinese Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase Ib clinical trial sponsored by Roche, primarily targeting patients with relapsed or refractory multiple myeloma. Patients must have received at least 1 prior line of standard anti-myeloma therapy, and their treatment history must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (i.e., triple-class exposed); patients who have previously received BCMA-targeted therapy are permitted to participate, and it must be assessed that no other standard therapeutic options are currently available. The treatment regimen uses an innovative biologic agent targeting FcRH5 (Cevostamab) as monotherapy, with dose escalation during the first cycle, followed by 21-day treatment cycles starting from Cycle 2, continuing treatment until disease progression. This study is a domestic clinical trial in China, currently conducted across 4 domestic core hospitals: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, The First Affiliated Hospital of Nanchang University, and The First Affiliated Hospital of Wenzhou Medical University.
Participating Centers0 in China + 4 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
- CTR20251016
- Verify on the NMPA CDE public platformby entering CTR20251016 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 ≤ 1, ≥ 1 prior lines of therapy. The study specifies 8 inclusion and 11 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 [T-cell redirecting bispecific antibody]. 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 Ib] 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 0 study centres in China and 4 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology)]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Nanchang University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20251016] (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 Ib
Target / Therapy
T-cell redirecting bispecific antibody
Sponsor
Roche (China) Investment Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology)
Participating Centers
0 in China + 4 overseas
CDE Registry ID
CTR20251016
Trial 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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