Ongoing Clinical Trials for Precursor B-lymphoblastic Lymphoma
There are currently 2 clinical trials testing innovative cell therapies for precursor B-lymphoblastic lymphoma and related blood cancers. These trials are exploring CAR T-cell treatments that use patients’ own modified immune cells to target cancer cells. The trials are taking place in Denmark and Germany, focusing on patients whose cancer has returned or not responded to standard treatments.
Clinical trial locations
- Denmark
- Germany
Study on CLIC-1901 CAR T-cells and Tocilizumab for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma
This trial, taking place in Denmark, is testing a treatment called CLIC-1901 CAR T-cell therapy for patients with certain blood cancers that have either returned after treatment or not responded to previous therapies. The study also involves the use of tocilizumab, a medication given through an infusion to help manage potential side effects.
Who can participate: Patients eligible for this trial must be between 1 and 70 years old and have a type of blood cancer that has come back or not responded to treatment. Participants need to have a life expectancy of at least 12 weeks and must have organs that are functioning well enough. This includes having adequate lung function with oxygen levels above 90% without extra oxygen, heart function showing more than 45% performance, and appropriate liver and kidney function tests. Patients must score above 50% on a test measuring their ability to perform daily activities. Both patients and their partners who can have children must agree to use very effective birth control methods from the time of a specific collection procedure until at least 12 months after receiving the treatment.
Who cannot participate: Patients with certain types of cancer who have not responded to previous treatments or whose cancer has returned might not be eligible. Those who fall outside the specified age range or who are considered part of a vulnerable population requiring special protection are excluded from the study.
What the trial involves: The treatment process begins with a procedure called leukapheresis, where white blood cells are collected from the patient’s blood. These cells are then modified in a laboratory over several weeks to create CLIC-1901 CAR T-cells, which are engineered to recognize and attack cancer cells expressing a protein called CD19. Before receiving the modified cells back, patients may undergo a short course of chemotherapy to prepare their body. The CAR T-cells are then infused into the bloodstream through an intravenous line in a one-time procedure. After the infusion, patients are closely monitored for their body’s response to the treatment, with regular follow-up visits to assess health status and manage any side effects. If side effects like cytokine release syndrome or neurotoxicity occur, treatments such as tocilizumab or glucocorticoids may be administered.
Investigational drug: The main treatment being tested is CLIC-1901 CAR T-cell therapy, which uses specially modified cells from the patient’s own immune system that are engineered to recognize and attack cancer cells expressing the CD19 protein.
Study on MB-CART19.1 for Patients with Relapsed or Refractory CD19 Positive B Cell Malignancies
This clinical trial in Germany is evaluating MB-CART19.1, another form of CAR T-cell therapy, for patients with blood cancers that have returned or not responded to treatment. The study is being conducted in two phases: the first to determine the best dose, and the second to assess how well the treatment reduces cancer cells in the body.
Who can participate: Patients must have a cancer that has come back or hasn’t responded to treatment, with cancer cells showing the CD19 marker confirmed through special tests like flow cytometry or immunohistochemistry. Participants must be at least 1 year old and have a certain number of CD3+ T cells in their blood. For those older than 16 years, an ECOG performance score of 0-2 is required, while those 16 or younger need a Lansky performance score of more than 50. Patients must not have active infections like Hepatitis B, Hepatitis C, or HIV. Women who can have children must have a negative pregnancy test before starting the trial, and all participants must sign a consent form to participate.
Who cannot participate: Patients who have a different type of cancer not related to CD19 positive B cell malignancies or who have not experienced a return or worsening of their cancer after treatment are not eligible. Pregnant or breastfeeding women cannot participate. Those unable to safely undergo the treatment due to other health conditions, unable to follow study procedures, who have received certain recent treatments that might interfere with the study, who have an active infection, who have a history of severe allergic reactions to similar treatments, or who have a condition affecting their immune system are also excluded.
What the trial involves: The process begins with an initial assessment to confirm eligibility, including various health tests. A leukapheresis procedure is then performed to collect T-cells from the patient’s blood. These cells are modified in a laboratory over several weeks to express a chimeric antigen receptor that targets CD19 on cancer cells. Before receiving the modified cells back, patients undergo chemotherapy to prepare their body for the infusion. The MB-CART19.1 cells are then infused into the bloodstream through an intravenous infusion in a one-time, closely monitored procedure. After the infusion, patients are monitored for immediate reactions and receive regular follow-up visits to assess treatment response. The effectiveness is evaluated at specific intervals, such as day 28 and month 3, to determine the overall response rate and any changes in the patient’s condition.
Investigational drug: The treatment being tested is MB-CART19.1, an adoptive cell therapy that involves modifying a patient’s own T cells to better recognize and attack cancer cells expressing the CD19 protein. This therapy uses chimeric antigen receptor (CAR) T-cell technology.
Summary
Both ongoing clinical trials for precursor B-lymphoblastic lymphoma and related blood cancers are testing similar approaches using CAR T-cell therapy, though with different specific formulations. These trials represent important advances in treating patients whose cancer has returned or not responded to standard treatments. The studies are geographically distributed across Denmark and Germany, each focusing on modifying patients’ own immune cells to target cancer cells expressing the CD19 protein. Both trials include comprehensive monitoring for safety and effectiveness, with particular attention to managing potential side effects. These innovative treatments offer hope for patients who have exhausted other treatment options, though they remain in the investigational stage to determine their safety and effectiveness.
