Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells
Recruiting now · Phase 1/Phase 2
Conditions studied: T Cell Lymphoma, T Cell Leukemia, T-cell Acute Lymphoblastic Leukemia, T-Cell Lymphoma of CNS, T Cell Prolymphocytic Leukemia, T Cell Childhood ALL
In brief
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.
Key facts
- Study ID
- NCT06420076
- Run by
- Essen Biotech
- People needed
- 60
- Starts
- 2024-07-10
- Expected to finish
- 2026-12-28
- Last updated by the study team
- 2024-11-12
Who can join
Age: 2 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- District One Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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