Clinical trial · Interventional
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
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Hematologic Malignancies | — | UNRESOLVED | — |
| T-Cell Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| T-Lymphoblastic Lymphoma | T Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous nano CD5-CAR T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Nano CD5-CAR T Cells for Relapsed/Refractory T-ALL/LBL
- description
- All enrolled patients will receive lymphodepleting chemotherapy with fludarabine (30 mg/m²/day for 3 days) and cyclophosphamide (250 mg/m²/day for 3 days), followed by a single intravenous infusion of autologous nano CD5-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.
- interventionNames
- Biological: Autologous nano CD5-CAR T Cells
Primary outcomes (1)
- measure
- Incidence of Dose-Limiting Toxicities (DLT)
- timeFrame
- 28 days after CAR-T cell infusion
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available