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Exploratory Study on the Treatment of Relapsed and Refractory B-cell Malignant Tumors With WGb-0301 Injection

ConditionB Cell Malignancies
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • WGb-0301 injection

    Drug

    WGb-0301 injection

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: WGb-0301 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity (DLT) and its incidence rate

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 year

Secondary outcomes

1

Objective response rate (ORR)

Time frame
Through study completion, an average of 2 year
2

Disease control rate (DCR)

Time frame
Through study completion, an average of 2 year
3

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
4

Progression free survival (PFS)

Time frame
From the date of initial treatment until the first confirmation of progression or death for any reason

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: