Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07362732

Exploratory Study on the Treatment of Recurrent and Refractory Hematological Malignancies With WGb-0302 Injection

At present, the treatment of multiple myeloma (MM) has evolved from traditional chemotherapy to a comprehensive model that includes targeted drugs, immunotherapy, etc. However, the prognosis of recurrent/refractory MM patients remains severe. For patients who are already resistant to multiple major drugs such as proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies, the prognosis is particularly poor. B-cell maturation antigen (BCMA) plays a crucial role in regulating B cell proliferation and survival. BCMA is expressed in various hematological malignancies such as multiple myeloma and has become an important biomarker, promising therapeutic target, and research direction for these diseases.

The advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. The core of LNP mRNA technology targeting BCMA is to encapsulate the mRNA encoding specific proteins (such as anti BCMA related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection. The experimental drug WGb 0302 injection is a BCMA based messenger RNA (mRNA) therapeutic drug, formed by loading mRNA encoding BCMA receptor related proteins onto lipid nanoparticles (LNP).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age range: 18-75 years old, gender not limited;
  • 2. Expected survival time exceeds 12 weeks;
  • 3. According to the diagnostic criteria of the International Myeloma Working Group (IMWG) for multiple myeloma, the diagnosis is multiple myeloma (MM), and the expression of BCMA target antigen is confirmed by flow cytometry, bone marrow pathology, and immunohistochemistry.
  • 4. Having measurable multiple myeloma lesions:
  • 5. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point;
  • 6. Before screening (at baseline), corresponding conditions should be met;
  • 7. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;
  • 8. Those who can understand this experiment and have signed the informed consent form.

Exclusion criteria

  • 1. Accompanied by other uncontrolled malignant tumors;
  • 2. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy less than 6 months after the first administration;
  • 3. Have received any anti myeloma treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, radiation therapy [excluding local radiotherapy for pain control], etc.) within 14 days prior to the first use of medication;
  • 4. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;
  • 5. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;
  • 6. Within 14 days prior to enrollment, there is an uncontrolled active infection. Note: If there is no evidence of active infection within 72 hours before enrollment, subjects who continue to use prophylactic antibiotics, antifungal drugs, or antiviral drugs are allowed;
  • 7. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;
  • 8. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;
  • 9. Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;
  • 10. Long term use of immunosuppressants due to autoimmune diseases or organ transplantation, except for recent or current inhaled corticosteroid therapy;
  • 11. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;
  • 12. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.

Treatment and study plan

WGb-0302 injection

Drug

WGb-0303 injection

Primary outcomes

  1. The incidence of dose limiting toxicity (DLT)

    Time frame: Within 90 days after the initial treatment

  2. Maximum tolerated dose (MTD)or optimal biological dose (OBD)

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Through study completion, an average of 2 years

  2. Progression free survival (PFS)

    Time frame: From date of initial treatment until the date of first comfired progression or date of death from any cause, whichever came first, assessed up to 24 months

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.