bispecific antibody · multiple myeloma Clinical Study
Official protocol title:ELRANATAMAB Post-Trial Access: An Open-Label, Single-Arm Study for Multiple Myeloma Study Participants Continuing in Pfizer-Sponsored ELRANATAMAB Clinical Studies
Trial Summary
This project is a post-trial access clinical study sponsored by Pfizer, primarily intended for patients with multiple myeloma who have completed an eligible qualifying parent study and continue to derive clinical benefit from elranatamab treatment. The treatment regimen uses the biologic elranatamab (a bispecific antibody), where participants will receive 76 mg once every 4 weeks (Q4W) administered as a subcutaneous abdominal injection, or continue to maintain the dose and schedule most recently received in the parent study, with an estimated total treatment duration of 65 cycles. The trial is conducted across 5 top domestic hospitals in China—The First Affiliated Hospital, Zhejiang University School of Medicine; Peking University Third Hospital; Shandong Provincial Hospital; Nanfang Hospital, Southern Medical University; and Sun Yat-sen University Cancer Center—as well as 10 top medical centers in countries and regions including the United States, Canada, Japan, and Taiwan, China (a total of 15 institutions globally).
Participating Centers2 in China + 5 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
- CTR20250938
- Verify on the NMPA CDE public platformby entering CTR20250938 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 [Multiple myeloma]. 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, acceptable performance status. The study specifies 2 inclusion and 2 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 [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 [Clinical Study] 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 5 overseas centres. The lead institution is [The First Affiliated Hospital, Zhejiang University School of Medicine]. Prominent sites include The First Affiliated Hospital, Zhejiang University School of Medicine, Peking University Third Hospital, Shandong Provincial Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20250938] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.
Key Information
Status
Recruiting
Phase
Clinical Study
Target / Therapy
bispecific antibody
Sponsor
Pfizer Investment Co., Ltd.
Principal Investigator
Zhen Cai
Lead Institution
The First Affiliated Hospital, Zhejiang University School of Medicine
Participating Centers
2 in China + 5 overseas
CDE Registry ID
CTR20250938
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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International participation must be confirmed directly with the study team. If a clinical trial is not practical, review our independent guide to CAR-T in China.
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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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