NCT06533579 Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
| NCT ID | NCT06533579 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Vironexis Biotherapeutics Inc. |
| Condition | B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2025-05-30 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.
Eligibility Criteria
Inclusion Criteria: * Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age * Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol * CD19-positive expression * AAV specified capsid total antibody \<1:400 * Protocol-specified ranges for renal, liver, cardiac and pulmonary function * Protocol-specified ranges for hematology parameters Exclusion Criteria: * Hepatoxicity (AST or ALT \> 2x upper limit of normal) * History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy * Pregnant or nursing (lactating) women * Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade * History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity * Chemotherapy given within the protocol-specified discontinuation timelines Other Inclusion/Exclusion criteria to be applied per protocol.
Contact & Investigator
Vironexis Clinical Trials
STUDY DIRECTOR
Vironexis Biotherapeutics Inc.
Frequently Asked Questions
Who can join the NCT06533579 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 90 Years, studying B-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06533579 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06533579 currently recruiting?
Yes, NCT06533579 is actively recruiting participants. Contact the research team at allen.reha@vironexis.com for enrollment information.
Where is the NCT06533579 trial being conducted?
This trial is being conducted at Duarte, United States, Los Angeles, United States, Denver, United States, Valhalla, United States and 5 additional locations.
Who is sponsoring the NCT06533579 clinical trial?
NCT06533579 is sponsored by Vironexis Biotherapeutics Inc.. The principal investigator is Vironexis Clinical Trials at Vironexis Biotherapeutics Inc.. The trial plans to enroll 32 participants.
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