Recombinant anti-BCMA and CD3 bispecific antib… · relapsed/refractory/maintenance multiple myeloma Phase I clinical trial
Official protocol title:A Phase I, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HL17 in Participants with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Hualan Genetic Engineering, primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have previously received autologous stem cell transplantation (or are ineligible for transplantation), have received at least 1 proteasome inhibitor (PI), 1 immunomodulatory drug (IMiD), and 1 anti-CD38 monoclonal antibody, and have not received T-cell redirecting therapy (such as chimeric antigen receptor T-cell (CAR-T) therapy or dual-target antibodies). The treatment regimen employs recombinant anti-BCMA and CD3 bispecific antibody injection (HL17), administered on a once-weekly or once-every-two-weeks schedule during induction and maintenance for up to 24 cycles. Domestic participating centers include PKU Healthcare Luzhong Hospital and other centers.
Participating Centers0 in China + 1 overseas
Source and Verification
Every fact on this page is derived from the original filing below. The source document is archived as a PDF for direct verification.
- Document type
- CDE clinical trial registration filing (original PDF)
- Official registration number
- CTR20260125
- Verify on the NMPA CDE public platformby entering CTR20260125 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
- 2026-09-04
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/Maintenance]. 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 18–75 years, ECOG performance status ≤ 1. 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 [Recombinant anti-BCMA and CD3 bispecific antibody 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 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 0 study centres in China and 1 overseas centres. Prominent sites include PKU Healthcare Luzhong Hospital. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20260125] (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
Recombinant anti-BCMA and CD3 bispecific antibody injection
Sponsor
Hualan Genetic Engineering (Henan) Co., Ltd.
Participating Centers
0 in China + 1 overseas
CDE Registry ID
CTR20260125
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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