AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A PHASE I/II STUDY TO INVESTIGATE THE SAFETY AND FEASIBILITY OF POINT-OF-CARE HUMAN-CD19 TARGETING CAR T-CELLS IN PAEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL MALIGNANCIES (PACMAN)

The PACMAN study is a clinical trial for children and young adults (up to 18 years old) who have specific types of B-cell cancers, like B-cell precursor ALL or B-cell Non-Hodgkin Lymphoma, that haven't responded to previous treatments or have come back. Researchers are testing a new type of cell therapy, called MB-huCART19.1, to see how safe it is and if it can be effectively used in hospitals. This treatment involves modifying a patient's own immune cells to fight their cancer. The study will look closely at any side effects within the first 28 days of treatment. They will also check how well the treatment works in reducing cancer cells and how long its effects last.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Prinses Maxima Centrum voor Kinderoncologie B.V.

Enrolment target

Start

16 Dec 2025

B-cell precursor ALL B-cell Non Hodgkin Lymphoma

What is this study about?

The PACMAN study is an important research project looking into a new way to treat certain blood cancers in young people. These cancers are called B-cell precursor Acute Lymphoblastic Leukaemia (ALL) and B-cell Non-Hodgkin Lymphoma. This study is for patients whose cancer has either returned after being treated before or has not responded well to standard treatments.

The new treatment being tested is called MB-huCART19.1. It's a type of 'CAR T-cell therapy'. This means doctors take some of a patient's own immune cells, called T-cells, and change them in a laboratory. These altered T-cells are then put back into the patient. The goal is for these new, specially trained T-cells to find and destroy the cancer cells. This study is special because it's looking at doing this treatment 'point-of-care', meaning it might be possible to prepare the treatment directly at the hospital where the patient is being treated, rather than sending cells away to a distant lab.

This study has two main goals. Firstly, it wants to make sure the treatment is safe for patients. Doctors will carefully watch for any side effects, especially in the first month after the treatment. Secondly, it wants to see if this treatment can be given successfully in a hospital setting and how well it helps control the cancer. The study is split into two parts: Phase I to find the safest dose, and Phase II to see how effective it is at that dose.

Key takeaways

This study is for children and young adults with certain B-cell blood cancers that have come back or not responded to other treatments.
It tests a new type of cell therapy (CAR T-cells) where your own immune cells are re-programmed to fight cancer.
The main goals are to check the safety of the treatment and how well it works.
'Point-of-care' means the treatment might be prepared directly at your hospital.
Participation involves receiving the cell therapy and careful monitoring by doctors.

Who may be eligible?

This study is looking for children and young adults who are 18 years old or younger. Both boys and girls can take part.

To be eligible, you must have a specific type of blood cancer called B-cell precursor ALL or B-cell Non-Hodgkin Lymphoma. It's important that your cancer has either come back after previous treatment or hasn't responded to other treatments given.

The research team will carry out several tests to ensure this study is the right fit for you. These tests help them check your overall health and how your body might respond to this new treatment. They will make sure that taking part in the study is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or younger?
Do you have B-cell precursor ALL or B-cell Non-Hodgkin Lymphoma?
Has your cancer come back or not responded to previous treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the MB-huCART19.1 cell therapy. Before the treatment, you will undergo several medical checks and procedures to prepare your body. The treatment involves collecting your blood, which contains your immune cells. These cells will then be sent to a special lab to be modified into the CAR T-cells. While your cells are being prepared, you may receive temporary treatments to keep your cancer under control.

Once the CAR T-cells are ready, they will be given back to you through a drip, similar to receiving a blood transfusion. After receiving the treatment, you will stay in the hospital for some time so the doctors can closely monitor you for any side effects. You will also have regular follow-up appointments, tests, and scans for a period of time to see how you are doing, how the treatment is working, and to check for any long-term effects. The total duration of your involvement in the study will depend on how you respond and how long the doctors need to monitor your health.

Potential risks and benefits

Taking part in this study might offer a chance to receive a new treatment for your cancer, especially if other treatments haven't worked. However, like all new treatments, there are potential risks, and side effects can occur. The study will closely monitor your health to identify and manage these potential side effects. It’s important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands

Common questions

What is a 'B-cell malignancy'?

A B-cell malignancy is a type of cancer that starts in certain white blood cells called B-cells. These cells are part of your immune system.

What does 'relapsed or refractory' mean?

It means the cancer has either returned after being treated, or it hasn't responded to previous treatments.

What is CAR T-cell therapy?

CAR T-cell therapy is a treatment where doctors take your own immune cells, specifically T-cells, change them in a lab so they can better find and fight your cancer cells, and then put them back into your body.

Will I have to travel for this treatment?

This study is looking at making the treatment available directly at the hospital where you receive care, which is called 'point-of-care', potentially reducing the need to send your cells to faraway labs.

What does Phase I and Phase II mean?

Phase I is about checking if a new treatment is safe and finding the best dose. Phase II is about seeing how well the treatment works in a larger group of patients once the safest dose is known.