RecruitingPhase IICTR20202322Small molecule targeted drug

Small molecule targeted drug · relapsed/refractory multiple myeloma Phase II clinical trial

Official protocol title:An Open-Label, Single-Arm Phase II Clinical Study Evaluating CX13-608 in Participants with Relapsed or Refractory Multiple Myeloma

Sponsor: Ningbo Shengjian Biotechnology Co., Ltd.Updated: 9/21/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

Trial Summary

This project is a phase II clinical trial sponsored by Ningbo Shengjian Biotechnology Co., Ltd., primarily enrolling participants with multiple myeloma who have received at least 2 prior therapy lines (must include an alkylating agent or an anthracycline, bortezomib, and an immunomodulatory agent) and have relapsed/refractory disease to their most recent therapy. The treatment regimen utilizes the chemical drug CX13-608 (intravenous injection) combined with low-dose dexamethasone (oral) in 28-day cycles (dosed 3 days per week for 3 consecutive weeks, followed by 1 week of rest) administered continuously. The trial is conducted across 10 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Renji Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Peking University Third Hospital, and Sun Yat-sen University Cancer Center.

Participating Centers0 in China + 10 overseas

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Renji Hospital, Shanghai Jiao Tong University School of Medicine
The First Affiliated Hospital, Zhejiang University School of Medicine
Peking University Third Hospital
Tianjin Medical University Cancer Institute & Hospital
Jiangsu Province Hospital
Sun Yat-sen University Cancer Center
Henan Cancer Hospital
The First Affiliated Hospital of Nanchang University
The Affiliated Hospital of Xuzhou Medical University

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
CTR20202322
Verify on the NMPA CDE public platformby entering CTR20202322 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
2026-09-21

Frequently Asked Questions about this Study

Structured facts derived from official protocol filings for patient and family reference

QWhich patient group is targeted by this clinical trial?

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.

QWhat are the specific eligibility criteria regarding age, performance status, and prior therapy?

According to verified protocol filings, key eligibility thresholds include: age 18–75 years, ECOG performance status ≤ 2, ≥ 2 prior lines of therapy. The study specifies 15 inclusion and 27 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.

QWhat are the investigational targets and mechanism of action?

The core therapeutic target or investigational mechanism is [Small molecule targeted drug]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.

QWhat clinical phase is this study in?

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.

QWhere are the participating hospital trial centers located?

This is an international multi-centre study with 0 study centres in China and 10 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, Renji Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, among others. Eligible domestic patients can seek screening at the nearest participating centre.

QWhat is the official trial registration code and how can it be verified?

The official public registration identifier for this protocol is [CTR20202322] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.

Note for International Patients: Trial centers for this study are located in China. Interventional trials strictly comply with domestic Human Genetic Resources (HGRAC) regulations and standard hospital protocols, which generally restrict enrollment to residents with domestic healthcare identification. International patients seeking approved cellular therapies should review commercial options.

Key Information

Status

Recruiting

Phase

Phase II

Target / Therapy

Small molecule targeted drug

Sponsor

Ningbo Shengjian Biotechnology Co., Ltd.

Principal Investigator

Lugui Qiu

Lead Institution

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Participating Centers

0 in China + 10 overseas

CDE Registry ID

CTR20202322

Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.

Where this study sits in the landscape

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Keywords

Ningbo ShengjianPhase IIrelapsed/refractory multiple myeloma (RRMM)CX13-608chemical drugdexamethasoneCTR20202322

Considering a non-trial option?

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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Evidence · Process · Costs · Verified hospitals

Patient Rights & Safety Assurance

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.

Read application guide & patient rights
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