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

June 25, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, open-label, non-randomized, single-arm Phase 1/2 study evaluating the safety and efficacy of autologous nano CD5-CAR T cells in adult and adolescent patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) who have failed prior standard therapies.

The Phase 1 portion uses a dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The Phase 2 portion will enroll patients at the RP2D to evaluate the overall response rate (ORR) per independent review committee (IRC) assessment.

Secondary objectives include assessment of duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety profile including adverse events (AEs) of special interest such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Key inclusion criteria include confirmed diagnosis of r/r T-ALL/T-LBL, adequate organ function, and measurable disease. Key exclusion criteria include active severe infection, prior allogeneic stem cell transplantation within 100 days, and known central nervous system involvement that is not controlled.

The study will enroll approximately [X] patients at multiple investigational sites in China. All patients will receive lymphodepleting chemotherapy followed by infusion of autologous nano CD5-CAR T cells. Safety assessments will be performed throughout the study period, including regular laboratory tests and clinical evaluations.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Nano CD5-CAR T Cells for Relapsed/Refractory T-ALL/LBL
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose-Limiting Toxicities (DLT)
Time Frame: 28 days after CAR-T cell infusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2026011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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