Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

Launched by ESSEN BIOTECH · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of treatment for patients with specific blood cancers, including T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma. The researchers are testing a special therapy called CAR-T cell therapy that targets proteins (CD5 and CD7) found on the surface of cancer cells. This trial aims to find out how safe this treatment is and whether it can help people whose cancer has not responded to other treatments.

To participate in this trial, patients should be between 2 and 60 years old and have a diagnosis of T-ALL or related conditions. They should have had trouble achieving complete remission or have had their cancer return after treatment. Participants will need to provide written consent and undergo certain health checks. Throughout the trial, they will be monitored for any side effects and how well the treatment works. It’s important for potential participants to discuss this option with their doctors to see if it’s a good fit for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed written informed consent; Patients volunteer to participate in the clinical trial;
• • Diagnosis is mainly based on the World Health Organization (WHO) 2008;
• • Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;
• • Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);
• • The expected survival period is greater than 12 weeks;
• • ECOG score ≤2;
• • Age 2-60 years old;
• • HGB≥70g/L (can be transfused);
• • Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.
• Exclusion Criteria:
• • Patients declining to consent for treatment
• • Prior solid organ transplantation
• • One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;
• • History of severe pulmonary dysfunction diseases;
• • Severe infection or persistent infection cannot be effectively controlled;
• • Severe autoimmune disease or congenital immunodeficiency;
• • Active hepatitis;
• • Human immunodeficiency virus (HIV) infection;
• • Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).