B Cell MalignanciesEarly Phase 1NCT07332663
Exploratory Study on the Treatment of Relapsed and Refractory B-cell Malignant Tumors With WGb-0301 Injection
A Early Phase 1 study testing WGb-0301 injection in people with B Cell Malignancies, run by Sichuan University.
Trial summary
Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B Cell Malignancies
- What is being tested?
- WGb-0301 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.
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 CD19 is to encapsulate the mRNA encoding specific proteins in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
The experimental drug WGb-0301 injection is a CD19 based messenger RNA (mRNA) therapeutic mRNA drug, formed by loading mRNA onto lipid nanoparticles (LNP). WGb-0301 injection has demonstrated efficient B-cell clearance activity and good safety in non clinical settings, supporting further clinical exploration in B-cell malignancies. It is expected to provide an innovative, safe, and accessible immunotherapy for B-cell malignancies, bringing better clinical benefits to more patients with B-cell malignancies.
- Conditions
- B Cell Malignancies
- Being tested
- WGb-0301 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGb-0301 injectionDrug
WGb-0301 injection
| Study group | Role | What they receive |
|---|---|---|
| WGb-0301 injection | Experimental | Not described Receives: Drug: WGb-0301 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) and its incidence rate
Measured: Within 90 days after the initial treatment
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Measured: Through study completion, an average of 2 year
Secondary outcomes (4)
Objective response rate (ORR)
Measured: Through study completion, an average of 2 year
Disease control rate (DCR)
Measured: Through study completion, an average of 2 year
Duration of response (DoR)
Measured: From the date of the first PR/CR to the date of the first confirmation of progress or death for any reason
Progression free survival (PFS)
Measured: From the date of initial treatment until the first confirmation of progression or death for any reason
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell MalignanciesStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332663
- Sponsor's protocol ID
- CD19 CAR-T for B cell cancer
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Treatment of Relapsed and Refractory B-cell Malignant Tumors With WGb-0301 Injection
- ClinicalTrials.gov ID
- NCT07332663
- Acronym / sponsor ID
- CD19 CAR-T for B cell cancer
- Conditions
- B Cell Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.
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 CD19 is to encapsulate the mRNA encoding specific proteins in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
The experimental drug WGb-0301 injection is a CD19 based messenger RNA (mRNA) therapeutic mRNA drug, formed by loading mRNA onto lipid nanoparticles (LNP). WGb-0301 injection has demonstrated efficient B-cell clearance activity and good safety in non clinical settings, supporting further clinical exploration in B-cell malignancies. It is expected to provide an innovative, safe, and accessible immunotherapy for B-cell malignancies, bringing better clinical benefits to more patients with B-cell malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WGb-0301 injection | Experimental | Drug: WGb-0301 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WGb-0301 injectionWGb-0301 injection | Drug | WGb-0301 injection |
Primary outcome
Dose limiting toxicity (DLT) and its incidence rate
Time frame: Within 90 days after the initial treatment
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Time frame: Through study completion, an average of 2 year
4 secondary outcomes
Objective response rate (ORR)
Time frame: Through study completion, an average of 2 year
Disease control rate (DCR)
Time frame: Through study completion, an average of 2 year
Duration of response (DoR)
Time frame: From the date of the first PR/CR to the date of the first confirmation of progress or death for any reason
Progression free survival (PFS)
Time frame: From the date of initial treatment until the first confirmation of progression or death for any reason
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing WGb-0301 injection in people with B Cell Malignancies, run by Sichuan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) and its incidence rate (time frame: Within 90 days after the initial treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.