CD20 × CD3 bispecific antibody · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GLB-002 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Trial Summary
This project is a Phase I clinical trial sponsored by Hangzhou GluBio Therapeutics Co., Ltd., primarily targeting patients with relapsed or refractory non-Hodgkin lymphoma (NHL) who have failed standard therapy or lack effective treatment options. The treatment regimen uses oral administration of the small molecule chemical drug GLB-002 capsules, with a 28-day treatment cycle. Depending on the assigned cohort, the drug is administered continuously on days 1–7, days 1–10, or days 1–14 of each cycle. The trial is currently conducted domestically only, across 14 top-tier domestic hospitals including Peking University Cancer Hospital, Fudan University Shanghai Cancer Center, Sun Yat-sen University Cancer Center, The First Affiliated Hospital, Zhejiang University School of Medicine, and Shengjing Hospital of China Medical University.
Participating Centers1 in China + 12 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
- CTR20233717
- Verify on the NMPA CDE public platformby entering CTR20233717 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. The study specifies 8 inclusion and 20 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 [CD20 × CD3 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 I] 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 1 study centres in China and 12 overseas centres. The lead institution is [Peking University Cancer Hospital]. Prominent sites include Peking University Cancer Hospital, Henan Cancer Hospital, Jiangxi Cancer Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20233717] (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 I
Target / Therapy
CD20 × CD3 bispecific antibody
Sponsor
Hangzhou GluBio Therapeutics Co., Ltd.
Principal Investigator
Yuqin Song
Lead Institution
Peking University Cancer Hospital
Participating Centers
1 in China + 12 overseas
CDE Registry ID
CTR20233717
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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