Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on UCART20x22 for Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Using a Drug Combination

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called B-cell Non-Hodgkin Lymphoma, specifically in cases where the disease has returned or has not responded to previous treatments. The study is testing a new treatment called UCART20x22, which is a type of cell therapy. Cell therapy involves using specially engineered cells to target and fight cancer cells. In this case, the treatment targets specific proteins on the cancer cells known as CD20 and CD22.

The purpose of the study is to evaluate the safety and effectiveness of UCART20x22 in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. The study is divided into two parts: the first part aims to find the best dose of the treatment, while the second part will further test the treatment's safety and confirm the best dose. Participants will receive the treatment through an intravenous infusion, which means it will be administered directly into a vein.

Throughout the study, participants will be closely monitored for any side effects and the treatment's ability to control the cancer. The study will also involve other medications, such as Fludarabine and Cyclophosphamide, which are commonly used in cancer treatment. These medications help prepare the body to receive the cell therapy. The trial will continue for several years to gather comprehensive data on the treatment's long-term effects and benefits.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, organ function, and previous test results for infections such as hepatitis B, hepatitis C, and HIV.

    A pregnancy test is performed for women of childbearing potential. The performance status is evaluated to ensure it meets the required criteria.

  2. Step 2

    Pre-treatment preparation

    Before starting the treatment, any previous treatment-related side effects must be resolved to a certain level. Autologous hematopoietic stem cells should be available if there is a high risk of prolonged blood-related side effects.

  3. Step 3

    Treatment phase

    The treatment involves several medications administered intravenously. The medications include fludarabine phosphate, cyclophosphamide, and alemtuzumab. The specific dosages and frequency are determined based on the study's requirements.

    The main medication being studied is UCART20x22, which is also administered intravenously. The goal is to find the right dose and evaluate its safety and effectiveness.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the safety and any side effects of the treatment. This includes checking for any adverse events and the body's response to the treatment.

    The study aims to understand how the treatment affects the disease and the patient's overall health. This involves regular follow-up visits and assessments.

  5. Step 5

    End of study

    At the end of the study, a final assessment is conducted to evaluate the overall impact of the treatment. This includes reviewing the patient's health status and any changes in the disease.

    The study's findings contribute to understanding the treatment's potential benefits and risks for future patients.

Who can join the trial?

12 criteria

  • Age between 18 and 80 years.
  • Must have adequate organ function, which means the kidneys, liver, heart, lungs, and bone marrow are working well.
  • Must test negative for hepatitis B using a blood test.
  • If considered high-risk for long-term blood-related side effects, must have their own stem cells available before starting treatment.
  • Must test negative for hepatitis C and HIV (human immunodeficiency virus).
  • Women who can have children must have a negative pregnancy test within 7 days before joining the study.
  • Must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • Must have relapsed or refractory mature B-cell Non-Hodgkin lymphoma that is positive for CD20 and/or CD22.
  • Must have a type of Non-Hodgkin lymphoma that fits the study criteria, excluding certain types like chronic lymphocytic leukemia and Burkitt's lymphoma.
  • Must have had at least 2 previous treatments for their lymphoma, including specific types of drugs and therapies.
  • Must have at least one measurable tumor according to specific medical guidelines.
  • Any side effects from previous lymphoma treatments must have improved to their normal state or to a mild level before starting the study treatment.

Who cannot join the trial?

10 criteria

  • Patients with a history of another type of cancer, unless it has been in complete remission for at least 2 years.
  • Patients who have had a heart attack or stroke in the past 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with known allergies to the study medication or its ingredients.
  • Patients who have received another investigational drug within the last 4 weeks.
  • Patients with severe liver or kidney disease.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients with a history of severe allergic reactions.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

UCART20x22 is a type of therapy that uses specially modified cells to help fight cancer. In this trial, it is being tested on people with a type of cancer called B-cell Non-Hodgkin Lymphoma, which has come back or has not responded to other treatments. The therapy involves using cells that have been changed in a lab to better recognize and attack cancer cells in the body. The goal is to see if this treatment is safe and how well it works in shrinking or controlling the cancer.

What is already known about the treatment

UCART20x22 – UCART20x22 is administered as an infusion directly into the bloodstream, allowing it to circulate and target specific cancer cells. It is currently being studied in clinical trials for its potential use in treating relapsed or refractory B-cell Non-Hodgkin lymphoma, a type of cancer that affects the lymphatic system. The medication works by using genetically modified immune cells to recognize and attack cancer cells, aiming to reduce the cancer's presence in the body. UCART20x22 falls under the category of immunotherapy, which harnesses the body's immune system to fight cancer.

Investigated diseases

Relapsed or refractory B-cell Non-Hodgkin lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. The disease is characterized by the return or persistence of cancer after initial treatment. It typically involves the uncontrolled growth of abnormal B-cells, which can form tumors in lymph nodes and other parts of the body. As the disease progresses, it can spread to other organs and tissues, disrupting normal bodily functions. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with periods of remission and relapse.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-501607-27-00Estimated enrolment85 patientsSponsorCellectis

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.