MRNA cancer therapy takes on tough B-Cell tumors
NCT ID NCT07332663
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new mRNA drug called WGb-0301 in 9 patients with B-cell cancers (like lymphoma or leukemia) that have come back or stopped responding to treatment. The drug uses lipid nanoparticles to deliver mRNA that targets a protein called CD19 on cancer cells. The main goal is to check safety and find the right dose, not yet to cure the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WGb-0301 injection (mRNA therapy targeting CD19, delivered via lipid nanoparticles)
- What this could lead to
- If it works, this could point toward a new treatment option for patients with B-cell cancers that have stopped responding to standard therapies.
- What could go wrong
- This is a very early, small trial (9 people) focused on safety, not effectiveness. The treatment may not work or could have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age range of 18-70 years old, gender not limited; * 2\. Expected survival time exceeds 12 weeks; * 3\. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines and meeting the corresponding frontline treatment line requirements; * 4\. There are assessable lesions (applicable only to lymphoma patients); * 5\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point; * 6\. The main organ functions well and the relevant examination indicators meet the corresponding requirements; * 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; * 3\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection; * 4\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases; * 5\. Participants with atrial or ventricular involvement; * 6\. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression; * 7\. 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; * 8\. Unstable pulmonary embolism, deep vein thrombosis, or other major 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; * 9\. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy; * 10\. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment; * 11\. Within 14 days prior to enrollment, there is an active or uncontrollable infection that requires systemic treatment (excluding simple urinary tract infections or upper respiratory tract infections); * 12\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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