RecruitingPhase 1ACTRN12625001195448

Clinical Trial To Assess the Efficacy and Safety of PMCC-COE19 in Patients with CD19-Expressing B-Cell Malignancies

A Phase I, Open-Label, Single Arm Trial to Assess the Efficacy and Safety of PMCC-COE19 in Patients with CD19-Expressing B-Cell Malignancies

Sponsor

Peter MacCallum Cancer Centre

Enrollment

12 participants

Start Date

Nov 10, 2025

Study Type

Interventional

Conditions

CD19 Positive Malignant B-cell Leukemia CD19 Positive Malignant B-cell Lymphoma CD19 expressing malignancies

Summary

This study is testing a new type of treatment called PMCC-COE19, which is a Chimeric Antigen Receptor T-cell (CAR-T) therapy. The purpose is to see whether PMCC-COE19 is safe and effective for people with blood cancers that express CD19 markers. Who is it for? You may be eligible for this study if you are aged 16 years or older, you have been diagnosed with a blood cancer with CD19-expressing B-cells - this might be leukaemia or lymphoma or another blood cancer, and you meet additional criteria relating to your wellbeing and ability to tolerate CAR-T therapy. Study details Participants who choose to enrol in this study will be given a single dose of the investigational treatment PMCC-COE19. To create this therapy, a participant’s own T-cells (a type of immune cell) will be collected from the blood and modified in a laboratory to specifically target CD19, a protein found on cancer cells. Before receiving the therapy, participants will be given chemotherapy to prepare their body (lymphodepletion). Treatment with PMCC-COE19 will then be given as a single infusion into a vein, anticipated to take 30 minutes. Up to 6 dose levels of PMCC-COE19 may be assessed in this study, but participants will only be given a single dose during the study. Blood tests and other assessments will be performed regularly to monitor safety and response to treatment. It is hoped that this study will show that PMCC-COE19 is safe to deliver to patients with CD19-expressing blood cancers, and to determine the highest dose of PMCC-COE19 that patients can safely receive.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of personalised cancer treatment called CAR-T cell therapy, specifically a product called PMCC-COE19. CAR-T therapy works by taking a patient's own immune cells (T-cells), modifying them in a laboratory to recognise and attack cancer cells that carry a protein called CD19, and then infusing those engineered cells back into the patient. It is being tested in people with blood cancers — such as leukaemia and lymphoma — where the cancer cells display the CD19 marker. Before receiving the therapy, participants undergo a short course of chemotherapy to prepare their immune system. The CAR-T cells are then given as a single 30-minute infusion. The study will test up to six different dose levels to determine the safest and most effective dose, with each participant receiving only one dose. You may be eligible if you are 16 or older, have a confirmed CD19-expressing B-cell blood cancer that has relapsed or not responded to at least two prior treatments, and are in reasonably good health overall. The study has detailed eligibility criteria involving heart, lung, kidney, and liver function, so a full review with a specialist is needed to confirm eligibility.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention PMCC-COE19 CAR-T Cells PMCC-COE19 is an autologous chimeric antigen receptor (CAR) T-cell product targeting CD19. Six dose levels are evaluable, until the maximum tolerated dose is iden

Intervention PMCC-COE19 CAR-T Cells PMCC-COE19 is an autologous chimeric antigen receptor (CAR) T-cell product targeting CD19. Six dose levels are evaluable, until the maximum tolerated dose is identified. PMCC-COE19 (CAR+ cells) dose levels to be assessed: Level 1 - 5 x 10^6 Level 2 - 10 x 10^6 Level 3 - 20 x 10^6 Level 4 - 30 x 10^6 Level 5 - 45 x 10^6 Level 6 - 60 x 10^6 Patients will be assigned to a dose level and receive one single dose (approximately 30 minutes) of PMCC COE19 via intravenous (IV) infusion on Day 0 of the study. PMCC-COE19 infusion will be given 48 to 72 hours after completing lymphodepleting chemotherapy. Following PMCC-COE19 infusion, which may occur in the in-patient setting or in the day centre, the patient will be admitted for a minimum of 7 days observation.

Locations(1)

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

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ACTRN12625001195448