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

NCT07678307 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2026011
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

T-Cell Acute Lymphoblastic Leukemia; T-Lymphoblastic Lymphoma; Relapsed/Refractory Hematologic Malignancies

Keywords

CD5-CAR-T Cell Therapy; Nano CAR-T; Relapsed Refractory T-ALL; Relapsed Refractory T-Lymphoblastic Lymphoma; Phase 1/2 Clinical Trial; Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• 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).

  28 days after CAR-T cell infusion

Study Arms (1)

Autologous Nano CD5-CAR T Cells for Relapsed/Refractory T-ALL/LBL

EXPERIMENTAL

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.

Biological: Autologous nano CD5-CAR T Cells

Interventions

Autologous nano CD5-CAR T Cells BIOLOGICAL

Autologous 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.

Autologous Nano CD5-CAR T Cells for Relapsed/Refractory T-ALL/LBL

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Central Study Contacts

liang Huang

CONTACT

+86 022-23608126; huangliang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share