Hematological MalignanciesEarly Phase 1NCT07362732

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

A Early Phase 1 study testing WGb-0302 injection in people with Hematological Malignancies, run by Sichuan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hematological Malignancies
What is being tested?: WGb-0302 injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 1 Feb 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

About this study

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).

Conditions: Hematological Malignancies
Being tested: WGb-0302 injection
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WGb-0302 injectionDrug
WGb-0303 injection

Study groups in NCT07362732
Study group	Role	What they receive
WGb-0302 injection, Escalation doses	Experimental	Not described Receives: Drug: WGb-0302 injection
WGb-0302 injection, Extended doses	Experimental	Not described Receives: Drug: WGb-0302 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of dose limiting toxicity (DLT)
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 years

Secondary outcomes (2)

Objective response rate (ORR)
Measured: Through study completion, an average of 2 years
Progression free survival (PFS)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202631 Dec 2028

First posted23 Jan 2026
Study start1 Feb 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 Hematological 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07362732
Sponsor's protocol ID: LNP-mRNA for BCMA
Status last verified: Jan 2026
First submitted: 14 Jan 2026
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Hematological Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Study on the Treatment of Recurrent and Refractory Hematological Malignancies With WGb-0302 Injection
ClinicalTrials.gov ID: NCT07362732
Acronym / sponsor ID: LNP-mRNA for BCMA
Conditions: Hematological Malignancies
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Sichuan UniversityUniversity, hospital or other
Study start: 1 Feb 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 23 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
WGb-0302 injection, Escalation doses	Experimental	Drug: WGb-0302 injection
WGb-0302 injection, Extended doses	Experimental	Drug: WGb-0302 injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

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 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;

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-0302 injectionWGb-0303 injection	Drug	WGb-0302 injection, Escalation doses, WGb-0302 injection, Extended doses

Primary outcome

The incidence of dose limiting toxicity (DLT)
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 years

2 secondary outcomes

Objective response rate (ORR)
Time frame: Through study completion, an average of 2 years
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

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 23 Jan 2026.

Related trials for Hematological Malignancies

Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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-0302 injection in people with Hematological 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 23 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?

The incidence of dose limiting toxicity (DLT) (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?

On the ClinicalTrials.gov record for NCT07362732.

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 23 Jan 2026.