RecruitingPhase 1ACTRN12621000762853

CAR T cell therapy for CD19-positive cancer - phase I clinical trial

Phase I Clinical Trial of MB.CART19.1 CD19 Chimeric Antigen Receptor (CAR) T Cells in Relapsed or Refractory CD19-Positive Haematological Malignancy

Sponsor

Metro North Hospital and Health Service

Enrollment

31 participants

Start Date

Jul 21, 2021

Study Type

Interventional

Conditions

B cell blood cancers, including non-Hodgkin's lymphoma and leukaemia.

Summary

The aim of this study is to determine whether it is safe to administer a type of personalized immune cell therapy made from the white blood cells of patients with blood cancer (lymphoma and leukaemia). Who is it for? You may be eligible for this study if you are aged 18 or older and have been diagnosed with a CD19-positive B –cell blood cancer, including non-Hodgkin lymphoma or leukaemia, that has not responded to other treatments or has relapsed after previous treatments. Study Details. This study will enrol only a small number of participants as the therapy is still in the early stages of testing. All enrolled participants will undergo a comprehensive medical assessment. Participants will then have white blood cells collected over 4-6 hours via a special machine. These collected white blood cells will be used to make Chimeric Antigen Receptor (CAR) T cells which takes twelve days. Participants who are able to safely undergo chemotherapy will be given three days of intravenous chemotherapy prior to the CAR T cell infusion, which is given as an inpatient. Participants will need to stay in hospital for a few days before and after the CAR T cell infusion and attend regular follow-up visits after hospital discharge for up to 15 years. It is hoped that this research will show that this type of CAR T cell therapy is safe in patients with blood cancers. This treatment may then be used to improve access to CAR T cell therapy and improve health outcomes of future patients with similar types of blood cancer.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

CAR T cell therapy is a cutting-edge cancer treatment where a patient's own immune cells (T cells) are taken from their blood, genetically engineered in a laboratory to recognise and attack cancer cells, and then infused back into the patient. This Phase 1 trial tests a locally developed CAR T cell therapy targeting a protein called CD19, which is found on the surface of many blood cancer cells including lymphoma and leukaemia. The primary goal of this early trial is to establish that the therapy is safe. Participants have their white blood cells collected, undergo a short course of chemotherapy to prepare the immune system, receive the CAR T cell infusion in hospital, and are then followed up closely — including long-term follow-up for up to 15 years — to monitor for both safety and cancer response. You may be eligible if you are 18 or over and have a CD19-positive blood cancer (such as non-Hodgkin lymphoma or leukaemia) that has not responded to or has relapsed after other treatments, and you are not eligible for or cannot access approved CAR T cell therapy through the TGA. Active infections, HIV, uncontrolled neurological conditions, and significant heart disease are among the exclusion criteria.

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

Description of intervention(s) / exposure: The study intervention is MB.CART19.1 CD19 CAR T cell therapy, which is a type of gene-modified immune cell made from the participant’s blood cells. The participants will undergo a medical assessment to assess suitability for CAR T cell therapy. He or she will then undergo leukapheresis, which is a procedure where a large number white blood cells are collected through the veins. The volume collected is 240 – 300 mL. The blood cells are taken to the hospital laboratory to be made into MB.CART19.1 CAR T cells. Where medically safe, the participants will be given intravenous chemotherapy, consisting of fludarabine 25mg/m2/day for 3 days and cyclophosphamide 250mg/m2/day for 3 days, prior to MB.CART19.1 CAR T cell infusion. Participants who are unable to safely undergo chemotherapy can still receive MB.CART19.1 CAR T cell infusion. The MB.CART19.1 CAR T cells is in a volume of up to 150mL and is given by a specialist nurse and usually takes less than 30 minutes. Participants will need to stay in hospital for a few days before and after MB.CART19.1 CAR T cell infusion and attend regular follow-up visits after hospital discharge. This is at least once a week for 4 weeks, then monthly for 3 months, 3-monthly for 2 years after cell infusion, and then yearly for up to 15 years. Only a single dose of CAR T cell is administered but additional doses are permitted in specific settings, which include loss of CAR T cells, re-emergence of B cells, and persistent or recurrent B cell cancer, provided additional cells are available and the participants consent to additional infusion and are at least four weeks after their most recent infusion.

Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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ACTRN12621000762853