Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL

Launched by HEBEI SENLANG BIOTECHNOLOGY INC., LTD. · Nov 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Senl-T7 CAR T cells for patients with a type of blood cancer known as relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). This means the treatment is for individuals whose cancer has come back after previous therapies or hasn’t responded to those treatments. To be eligible for the study, participants should be between the ages of 2 and 70, have a specific type of cancer that shows CD7 on the tumor cells, and have a life expectancy of at least 12 weeks. They should also meet certain health criteria, like having good blood oxygen levels and certain lab test results.

Participants in this trial can expect to receive the Senl-T7 treatment and have their safety and how well the treatment works closely monitored. The study aims to gather important information about how the treatment affects patients, and researchers will also look at how the body processes the treatment. It’s important for potential participants to know that there are specific health conditions that would exclude them from the trial, such as certain heart problems, active infections, or recent severe illnesses. If you or a loved one are considering this trial, it’s essential to understand these criteria and discuss any questions with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；
• • 2. CD7 expression in tumor cells was detected by flow cytometry；
• • 3. Life expectancy greater than 12 weeks；
• • 4. KPS or Lansky score≥60;
• • 5. HGB≥70g/L (can be transfused);
• • 6. 2-70 years old;
• • 7. Oxygen saturation of blood#90%#;
• • 8. HGB≥70g/L（blood transfusion allowed）;
• • 9. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
• • 10. Informed consent explained to, understood by and signed by patient/ guardian.
• Exclusion Criteria:
• • 1. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\<30% or LVEF(left ventricular ejection fraction)\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
• • 2. Has an active GvHD;
• • 3. Has a history of severe pulmonary function damaging;
• • 4. With other tumors which is/are in advanced malignant and has/have systemic metastasis;
• • 5. Severe or persistent infection that cannot be effectively controlled;
• • 6. Merging severe autoimmune diseases or immunodeficiency disease;
• • 7. Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]);
• • 8. Patients with HIV infection or syphilis infection;
• • 9. Has a history of serious allergies on Biological products (including antibiotics);
• • 10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6;
• • 11. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
• • 12. Have received transplant treatment for less than 6 months in prior to enrollment;
• • 13. Being pregnant and lactating or having pregnancy within 12 months;
• • 14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.