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CAR T-cell Therapy

Gene Therapy for Acute Lymphoblastic Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Vironexis Biotherapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed B-cell ALL with bone marrow blasts >= 5%
Refractory B-cell ALL as defined in the protocol
Must not have
Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade
History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment called VNX-101 in patients with a type of leukemia called B-cell acute lymphoblastic leukemia. The trial is focusing on evaluating the safety and effectiveness of V

Who is the study for?
This trial is for adults and teens with B-cell acute lymphoblastic leukemia that has come back or hasn't responded to treatment. They should have a certain amount of cancer cells in their bone marrow, can't be treated with CAR-T therapy or didn't improve after it, and must meet specific health criteria for major organs and blood.
What is being tested?
The study tests different doses of VNX-101, a gene therapy drug, to see how safe it is and how well it works against leukemia. It's an early-stage trial where patients receive increasing amounts of the drug to find the best dose.
What are the potential side effects?
As this is a first-in-human study for VNX-101, potential side effects are not fully known but may include reactions at the infusion site, flu-like symptoms, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia has returned and more than 5% of my bone marrow cells are cancerous.
Select...
My B-cell ALL does not respond to standard treatments.
Select...
I cannot or chose not to receive CAR-T therapy, or it did not work for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have moderate to severe acute GvHD or any grade of chronic GvHD.
Select...
I have a history of blood vessel or heart muscle disease, or nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Group 1/Group 2/Group 3/Group 4Experimental Treatment4 Interventions

Find a Location

Who is running the clinical trial?

Vironexis Biotherapeutics Inc.Lead Sponsor
Vironexis Clinical TrialsStudy DirectorVironexis Biotherapeutics Inc.
~17 spots leftby Jun 2026
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