A Multicenter, Open-label, Non-randomized, Single-arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma

Starting soon · Phase 1/Phase 2

Conditions studied: T-Cell Acute Lymphoblastic Leukemia, T-Lymphoblastic Lymphoma, Relapsed/Refractory Hematologic Malignancies

In brief

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.

Key facts

Study ID

NCT07678307

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

18

Starts

2026-06-30

Expected to finish

2027-12-31

Last updated by the study team

2026-07-01

Who can join

Age: 3 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Able to understand and sign informed consent

You may not qualify if…

• Active severe infection or uncontrolled sepsis
• History of allogeneic stem cell transplantation within 3 months
• Severe autoimmune disease or immunodeficiency
• Prior CD5-targeted therapy
• Pregnant or breastfeeding women
• Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol

Full record on ClinicalTrials.gov

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