This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma.
The study will test a new treatment called "autologous nano CD5-CAR T cells". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells.
This study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works.
You may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts.
Possible risks include fever, low blood pressure, and infection, which the study team will monitor closely.
Age 3 to 70 years old
Diagnosed with CD5-positive relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
ECOG performance status 0-2
Adequate organ function (renal, hepatic, cardiac, pulmonary)
Active severe infection or uncontrolled sepsis
History of allogeneic stem cell transplantation within 3 months
Severe autoimmune disease or immunodeficiency
Prior CD5-targeted therapy
Single group
Autologous nano CD5-CAR T Cells
Biological/VaccineAutologous CD5-targeted CAR-T cells engineered with a novel nano antibody-based chimeric antigen receptor. Patients receive lymphodepleting chemotherapy (fludarabine 30 mg/m²/day + cyclophosphamide 250 mg/m²/day for 3 days) followed by a single intravenous infusion of CAR-T cells. The study uses a dose-escalation design with two main dose levels: 1.0×10\^6 cells/kg and 2.0×10\^6 cells/kg, with a backup low dose of 0.5×10\^6 cells/kg for use in case of insufficient cell yield.
Incidence of Dose-Limiting Toxicities (DLT)
Proportion of patients experiencing dose-limiting toxicities (DLT) within 28 days after CAR-T infusion, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
