NCT07678307Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- 30 Jun 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- NCT number
- NCT07678307
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 18
- From 30 Jun 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CD5-targeted therapy
Other illness
- Active severe infection or uncontrolled sepsis
- History of allogeneic stem cell transplantation within 3 months
- Severe autoimmune disease or immunodeficiency
- Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 3 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.