Ongoing Clinical Trials for T-cell Type Acute Leukaemia
This article provides detailed information about 6 ongoing clinical trials investigating new treatments for T-cell Type Acute Leukaemia (also known as T-cell Acute Lymphoblastic Leukemia, T-ALL). These trials are testing innovative therapies including CAR-T cell therapies, monoclonal antibodies, and combination treatments in patients with relapsed or refractory disease. Trials are currently recruiting patients in Italy, Spain, and Germany.
Clinical trial locations
- Germany
- Italy
- Spain
- Long-term Follow-up Study for Patients with Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma Treated with OC-1 Cells
- Study of CART84 Treatment for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia and T-Cell Acute Lymphoblastic Leukemia
- Study on the Safety and Effectiveness of OC-1 Therapy for Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or Lymphoma
Study for Adults with Very High-Risk T-Cell Acute Lymphoblastic Leukemia Using Daratumumab and a Drug Combination
This clinical trial is investigating the addition of Daratumumab to standard chemotherapy for adults with very high-risk T-cell acute lymphoblastic leukemia. The study focuses on determining whether this combination can improve treatment outcomes, particularly in achieving MRD-negativity, which means reducing cancer cells to very low levels after the first treatment cycle.
Main inclusion criteria: Participants must be between 18 and 65 years old with a confirmed diagnosis of T-lineage acute lymphoblastic leukemia. The cancer cells must show CD38 positivity and meet specific high-risk criteria. Participants must have at least 20% cancer cells in their bone marrow at diagnosis and be able to perform most daily activities.
Main exclusion criteria: Patients with other types of leukemia, those outside the specified age range, pregnant or breastfeeding women, and those with serious health conditions that could interfere with the study cannot participate. Patients with allergies to the study medications or who cannot follow study procedures are also excluded.
Main focus: The trial aims to evaluate whether adding Daratumumab to standard treatment increases the rate of patients achieving minimal residual disease negativity after the first treatment cycle. The study will monitor patients through induction, consolidation, and maintenance phases, with regular assessments including blood tests and bone marrow examinations.
Investigational drug: Daratumumab is a monoclonal antibody that targets specific proteins on the surface of cancer cells, helping the immune system identify and destroy them. It is administered intravenously in combination with various chemotherapy medications.
Study of CART84 Treatment for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia and T-Cell Acute Lymphoblastic Leukemia
This study tests a new treatment called CART84 for patients whose disease has not responded to previous treatments or has returned. The treatment uses the patient’s own immune cells, which are modified in a laboratory to better fight cancer cells and then returned to the patient through an infusion.
Main inclusion criteria: Participants must be 18 years or older with at least 5% leukemia cells in their blood or bone marrow. They must have disease that didn’t respond to initial treatment, has relapsed, or returned after stem cell transplant. The cancer cells must show CD84 protein presence. Patients must have adequate organ function and a potential stem cell donor available.
Main exclusion criteria: Patients with active infections including hepatitis B, hepatitis C, or HIV cannot participate. Those with other cancers in the past 3 years, pregnant or breastfeeding women, and patients with severe heart, lung, kidney, or liver problems are excluded. Previous CAR-T cell therapy also disqualifies participation.
Main focus: The trial aims to determine the safety of CART84 and find the most effective dose for treating relapsed or refractory disease. After receiving CART84 treatment, some patients may proceed to stem cell transplant. Regular monitoring includes blood tests and bone marrow examinations to assess treatment response.
Investigational drug: CART84 is a cell therapy where a patient’s T-cells are genetically modified to recognize and attack cancer cells expressing CD84. The modified cells are administered as an intravenous infusion.
Study of CD7-CART01, Cyclophosphamide, and Fludarabine Phosphate for Children and Young Adults with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma
This trial is testing CD7-CART01, a new treatment using specially modified cells to target and fight cancer in children and young adults whose disease has relapsed or not responded to treatment. The therapy is combined with standard chemotherapy medications including Cyclophosphamide and Fludarabine Phosphate.
Main inclusion criteria: Participants must be between 6 months and 25 years old with CD7-expressing disease, meaning more than 98% of cancer cells show the CD7 marker. Patients must have adequate venous access for cell collection, a clinical performance status of at least 60%, and measurable disease. A potential stem cell donor must be available before starting treatment.
Main exclusion criteria: Patients with different types of cancer, those outside the specified age range, pregnant or breastfeeding patients, and those who cannot follow study procedures are excluded. Patients who have received certain recent treatments that might interfere with the study or have active infections are also ineligible.
Main focus: The study has two phases. Phase one focuses on ensuring treatment safety and finding the right dose. Phase two evaluates how well the treatment works at the established dose. The trial aims to assess both safety and effectiveness of this CAR-T cell therapy approach.
Investigational drug: CD7-CART01 consists of genetically engineered T cells that express a chimeric antigen receptor targeting the CD7 protein found on cancer cells. The modified cells are administered through infusion after a conditioning regimen.
Study on the Safety and Effectiveness of Isatuximab and Drug Combination for Adults with Relapsed or Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
This clinical trial investigates Isatuximab, a humanized monoclonal antibody targeting CD38, for adults with disease that has returned or is resistant to treatment. The study evaluates Isatuximab both as part of combination chemotherapy and as a single treatment.
Main inclusion criteria: Participants must be 18 years or older with CD38 positive disease and fit definitions for specific treatment cohorts. They must have adequate kidney and liver function, with creatinine clearance of 40 mL/min or higher. Women of childbearing potential must have a negative pregnancy test and agree to use reliable birth control methods.
Main exclusion criteria: Patients without CD38 positive disease, those not experiencing relapsed or refractory conditions, and vulnerable populations requiring special protection cannot participate. Patients not meeting specific health criteria or outside the specified age range are also excluded.
Main focus: The trial monitors treatment response through regular blood tests, imaging studies, and other assessments. The primary goal is achieving complete hematologic response, meaning the absence of detectable cancer cells in blood and bone marrow. The study will continue until 2028.
Investigational drug: Isatuximab is administered intravenously and targets the CD38 protein on cancer cell surfaces, helping the immune system identify and destroy these cells. It belongs to the class of monoclonal antibodies and may be used alone or with chemotherapy including Cytarabine, Cyclophosphamide, Daunorubicin, and other medications.
Study on the Safety and Effectiveness of OC-1 Therapy for Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or Lymphoma
This trial studies the safety and effectiveness of hCD1a-CAR T (OC-1) therapy for patients whose cancer has returned or not responded to previous treatments. The treatment uses the patient’s own immune cells, modified to better recognize and attack cancer cells when reintroduced into the bloodstream.
Main inclusion criteria: Patients must be children older than 2 years or adults with CD1a antigen present in at least 20% of cancer cells, confirmed through flow cytometry or tissue examination. Eligible patients include those with relapse after stem cell transplant, primary refractoriness after two standard treatments, refractory first relapse, or second or further relapse. Patients must agree to use effective birth control.
Main exclusion criteria: Patients with different cancer types, those outside the age range, pregnant or breastfeeding patients, and those unable to follow study procedures cannot participate. Patients with serious health conditions interfering with the study, recent participation in other trials, or allergies to study medication are also excluded.
Main focus: The study assesses the safety of hCD1a-CAR T therapy through monitoring adverse events and evaluating treatment effectiveness in controlling cancer. Researchers monitor remission rates, overall survival, and how long the modified immune cells remain active in the body through regular check-ups.
Investigational drug: hCD1a-CAR T (OC-1) consists of genetically modified T-cells engineered to recognize the CD1a marker on cancer cells. The therapy is administered through intravenous infusion after T-cells are collected, modified in a laboratory using a lentiviral vector, and prepared for infusion.
Long-term Follow-up Study for Patients with Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma Treated with OC-1 Cells
This clinical trial focuses on long-term monitoring of patients who have already received OC-1 cell therapy. The study follows these patients for up to 15 years to check for any delayed side effects or adverse events and to understand the long-term safety and effectiveness of the treatment.
Main inclusion criteria: Patients must have been previously treated with at least one fraction of OC-1 cell investigational product. Both males and females can participate, including vulnerable populations. The patient or their legal representative must provide signed informed consent and be able to comply with study requirements.
Main exclusion criteria: Patients with different cancer types, those who haven’t experienced cancer return or resistance to treatment, those not positive for CD1a marker, patients who haven’t received OC-1 cells, and those unwilling to be monitored for 15 years cannot participate.
Main focus: The study monitors for delayed adverse events over 15 years following CAR-T cell infusion. Regular assessments check for new medical conditions including new malignancies, neurological disorders, autoimmune disorders, hematologic disorders, infections, and skin disorders. The trial evaluates overall survival, progression-free survival, and the persistence of OC-1 cells in the body.
Investigational drug: OC-1 cells are CAR-T cells (hCD1a-CAR T) administered as a suspension for intravenous infusion. These are the patient’s own T-cells that were previously modified to target CD1a-positive cancer cells. The study focuses on long-term monitoring rather than active treatment administration.
Summary
Six clinical trials are currently investigating treatments for T-cell Type Acute Leukaemia across three European countries. Spain hosts the most trials with three studies, followed by Italy with two, and Germany with one. A notable trend is the focus on CAR-T cell therapies, with four trials testing this innovative approach using different targets: CD7, CD1a, and CD84. These therapies involve modifying patients’ own immune cells to better recognize and attack cancer cells.
Two trials investigate monoclonal antibodies: Daratumumab in Italy for very high-risk newly diagnosed patients, and Isatuximab in Germany for relapsed or refractory disease. Both target CD38 on cancer cells. The majority of trials focus on relapsed or refractory disease, reflecting the challenging nature of treating patients who have not responded to or have relapsed after standard therapies.
The age ranges vary considerably, with some trials accepting children as young as 6 months alongside young adults up to 25 years, while others focus exclusively on adults. One trial in Spain specifically monitors long-term outcomes for up to 15 years in patients who have already received CAR-T cell therapy, highlighting the importance of understanding delayed effects of these novel treatments.
Common eligibility requirements include adequate organ function, specific biomarker expression on cancer cells, and the availability of stem cell donors for some studies. The trials represent a range of approaches from early-phase safety studies to those evaluating effectiveness at established doses, providing hope for patients with this aggressive form of blood cancer.