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A Study of Allo-QuadCAR01-T Cell Therapy for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

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What is this trial about?

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

This study is looking at people who have relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia. These are types of blood cancer that affect a certain kind of white blood cell called B-cells. Relapsed means the cancer has come back after treatment, and refractory means it has not responded well to previous treatments. The specific types of lymphoma that can be included are large B-cell lymphoma, which includes conditions like diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed large B-cell lymphoma from a slower-growing lymphoma or chronic lymphocytic leukaemia, and primary mediastinal large B-cell lymphoma. Other types that can be included are follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, and chronic lymphocytic leukaemia or small lymphocytic leukaemia. The treatment being tested is called Allo-QuadCAR01-T, which is a type of therapy made from immune cells that have been modified to recognize and attack cancer cells that have certain markers called CD19 and CD20 on their surface. This treatment is given as an intravenous infusion, which means it is delivered directly into a vein.

The purpose of the study is to test the safety of different doses of Allo-QuadCAR01-T in the early phases and to find the best dose to use. In the later phase, the study aims to see how well this treatment works at controlling or eliminating the cancer. The study is divided into three parts. In the first part, called Phase Ia, different dose levels of the treatment will be tested to see if they are safe and well-tolerated. In Phase Ib, the treatment will continue to be tested for safety and the researchers will confirm the recommended dose for the next phase. In Phase II, the study will focus on measuring how effective the treatment is at making the cancer respond or disappear.

Patients in this study will need to have their disease confirmed by tissue examination and must have received at least two previous treatments, or be unsuitable for standard treatments, or have chosen not to receive them. Before receiving Allo-QuadCAR01-T, patients will undergo tests to make sure they meet the requirements, including having their tissue type matched to available treatment batches. The treatment itself is given after a short course of chemotherapy to prepare the body. During and after the treatment, patients will be monitored closely for side effects and to see how well the cancer responds. This monitoring includes blood tests, imaging scans, and other assessments to track the cancer and the immune cells over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment preparation and lymphodepleting chemotherapy
Before receiving the study treatment, your body will be prepared with lymphodepleting chemotherapy. This is a treatment that reduces the number of certain immune cells in your blood to help the study medication work better.
The specific medications, doses, and duration of this preparatory chemotherapy will be determined by the study doctor based on your individual situation.
Step 2
Administration of Allo-QuadCAR01-T
You will receive Allo-QuadCAR01-T as a single intravenous infusion. This means the medication will be given directly into your vein through a drip.
The medication is a type of cell therapy that targets two proteins called CD19 and CD20 found on certain cancer cells.
The dose you receive will depend on which phase of the study you are in and will be calculated based on your body weight. The maximum dose will not exceed 100,000 cells per kilogram of your body weight.
The infusion will be given through a central venous access, which is a special type of intravenous line. If you do not already have one, it will be placed before treatment.
Step 3
Early monitoring period after infusion
After receiving the infusion, you will be monitored closely for any side effects or reactions to the treatment.
During this period, the study team will check your vital signs, perform blood tests, and assess how you are feeling.
This close monitoring is important to ensure your safety and to observe how your body responds to the treatment.
Step 4
Week 13 assessment
At week 13 after receiving the infusion, you will undergo a comprehensive assessment to evaluate how well the treatment is working.
This assessment will include imaging scans such as CT or MRI to measure any changes in your disease.
For lymphoma patients, the assessment will look for measurable changes in lymph nodes or other affected areas. For chronic lymphocytic leukemia patients, blood tests and other measurements will be performed.
The study team will determine if you have achieved a complete response, which means no detectable signs of disease, or a partial response, which means the disease has decreased but is still present.
Blood samples will be collected to check for minimal residual disease, which means very small amounts of cancer cells that may remain even if scans appear clear.
Step 5
Ongoing monitoring and follow-up visits
After the week 13 assessment, you will continue to have regular follow-up visits for ongoing monitoring.
During these visits, blood samples will be taken to monitor several factors including how long the treatment cells remain in your body, your immune cell counts, and whether your body has developed any antibodies against the treatment.
The study team will track your B-cells, T-cells, and natural killer cells, which are types of immune cells in your blood.
You will be monitored for any side effects or complications that may occur over time.
The duration and frequency of these follow-up visits will be determined by the study protocol and your individual response to treatment.
Step 6
Long-term safety monitoring
You will be followed for long-term safety and to assess how long the treatment continues to work.
The study team will track important outcomes such as duration of response, which measures how long your disease remains controlled, progression-free survival, which measures how long you live without the disease worsening, and overall survival.
Information will also be collected about when or if you need additional cancer treatment in the future.
This long-term follow-up is essential to understand the full effects of the treatment over time.

Who can join the trial?

22 criteria

You must be 18 years of age or older
You must be willing and able to provide written informed consent, which means signing a document that shows you understand and agree to participate in the study
You must have a confirmed diagnosis of B-cell non-Hodgkin lymphoma (a type of cancer affecting white blood cells called B-cells) or chronic lymphocytic leukemia (a slow-growing blood cancer) that has come back after treatment or has not responded to treatment
Your cancer must be expected to have certain proteins on its surface called CD19 and CD20
You must have already received at least 2 previous treatments, or you are not suitable for standard treatments, or you have chosen not to receive standard treatments available through your healthcare system
You must have a current medical need for treatment
For lymphoma patients: you must have at least one tumor that can be measured on a CT or MRI scan (imaging tests that create pictures of the inside of your body), with the longest part being larger than 1.5 centimeters if in a lymph node, or larger than 1 centimeter if outside lymph nodes
For chronic lymphocytic leukemia patients: you must have a clear medical reason for needing treatment and have disease that can be measured, such as high white blood cell counts, enlarged lymph nodes, enlarged spleen, or other measurable signs
You must have a tissue sample from a biopsy (a small piece of tissue taken for testing) available from after your last treatment, or be willing to provide one, unless it would be unsafe or cause too much discomfort
Your HLA type (a set of proteins on your cells that help your immune system recognize what belongs in your body) must match one or more of the available study treatment batches. Specifically, your HLA B and C types must match
You must have an ECOG performance status of 0 to 1, which means you are fully active or able to carry out light work with only some restrictions on physically demanding activities
Your kidney function must be adequate, with a calculated clearance rate of at least 60 milliliters per minute
Your liver function must be adequate: bilirubin (a substance made when the liver breaks down old blood cells) must be no more than 1.5 times the upper normal limit, unless you have Gilbert's syndrome (a harmless condition affecting bilirubin processing)
Your liver enzymes called AST and ALT must be no more than 2.5 times the upper normal limit, or up to 5 times if the increase is directly caused by cancer in your liver
Your heart function must be adequate, with a left ventricular ejection fraction (a measure of how well your heart pumps blood) of at least 45 percent
Your oxygen saturation (the amount of oxygen in your blood) must be at least 92 percent while breathing regular room air
Your blood counts must be adequate: absolute neutrophil count (a type of white blood cell that fights infection) must be at least 1.0, platelets (cells that help blood clot) must be at least 50, and hemoglobin (the protein in red blood cells that carries oxygen) must be at least 7 grams per deciliter
You must have a life expectancy of at least 3 months as determined by your doctor
You must have a central venous access (a special tube placed in a large vein for giving treatments) or be willing to have one placed
Your weight must be above a certain minimum required for the specific treatment batch to ensure safe dosing
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and be willing to use a highly effective birth control method for at least 12 months after receiving the chemotherapy given before the study treatment
If you are a man, you must use a highly effective birth control method and not father a child or donate sperm for at least 6 months after receiving the chemotherapy given before the study treatment

Who cannot join the trial?

1 criterion

The study does not list specific exclusion criteria in the provided information, which means details about who cannot participate are not available in this document. Your doctor will need to review your complete medical history to determine if you are eligible for this study.

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Verified sites

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

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany

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Investigated drugs

Allo-QuadCAR01-T is an experimental cell therapy being tested in this trial. It is made from immune cells called T-cells that have been modified in a laboratory to recognize and attack cancer cells. These modified cells are designed to target two specific proteins, CD19 and CD20, which are found on the surface of certain cancer cells in B-cell malignancies. The therapy is "allogeneic," which means the T-cells come from a donor rather than from the patient's own body. This treatment aims to help the immune system find and destroy cancer cells in patients whose cancer has come back or has not responded to other treatments.

ALLO-QUADCAR01-T

What is already known about the treatment

Allo-QuadCAR01-T – This is an experimental cell therapy that is given through infusion into the bloodstream, currently being tested in early-stage clinical trials for patients with B-cell cancers that have come back or stopped responding to previous treatments. The medication works by using specially modified immune cells from a donor that are designed to recognize and attack cancer cells displaying two specific proteins called CD19 and CD20 on their surface. It belongs to a class of treatments called allogeneic CAR-T cell therapies, which use genetically engineered immune cells from healthy donors rather than from the patient themselves. The treatment is being studied for conditions including non-Hodgkin lymphoma and chronic lymphocytic leukemia, with ongoing research to determine the safest dose and how well it works in eliminating cancer cells.

Investigated diseases

Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
This is a type of cancer that affects B-cells, which are a kind of white blood cell that helps fight infections. Non-Hodgkin lymphoma occurs when these B-cells grow abnormally and uncontrollably, forming tumors in the lymph nodes or other parts of the body. The term "relapsed" means the disease has come back after treatment, while "refractory" means it has not responded to previous treatments. The cancer cells continue to multiply despite therapy, causing the lymph nodes to swell and potentially affecting other organs. As the disease progresses, patients may experience symptoms such as swollen lymph nodes, fever, night sweats, weight loss, and fatigue. The condition requires ongoing medical management as it continues to resist or return after standard treatments.
Chronic Lymphocytic Leukemia
This is a type of cancer that affects the blood and bone marrow, specifically involving B-cells. In this condition, the bone marrow produces too many abnormal white blood cells called lymphocytes that do not function properly. These abnormal cells gradually accumulate in the blood, bone marrow, lymph nodes, and spleen over time. The disease typically progresses slowly, which is why it is called "chronic," and many people may not have symptoms in the early stages. As the disease advances, the buildup of abnormal cells can crowd out healthy blood cells, leading to problems such as frequent infections, anemia, easy bruising or bleeding, and swollen lymph nodes. The accumulation of these dysfunctional cells interferes with the body's normal immune response and blood cell production.