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Recruiting NCT06633354

Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

Early Phase I Interventional T-Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD5 CAR T-cells.
Who it may be relevant to
Registry conditions: T-Acute Lymphoblastic Leukemia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

Overview

A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL

Detailed description

In this study, 30 patients with relapsed refractory T-ALL were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-ALL; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-ALL were accumulated.

Interventions

  • Biological CD5 CAR T-cells
    Each subject receive CD5+ T-ALL Targeted CAR T-cells by intravenous infusion

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Up to 28 days after Treatment]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after Treatment]
Secondary outcome measures (4)
  • Overall response rate ,ORR [Time frame: Up to 12 weeks after CAR-T infusion]
  • Duration of remission ,DOR [Time frame: Up to 1 years after CAR-T infusion]
  • Progression Free Survival, PFS [Time frame: Up to 2 years after Treatment]
  • Overall survival, OS [Time frame: Up to 1 years after CAR-T infusion]

Eligibility criteria

Inclusion criteria

  • 1\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
  • 2\. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:
  • No CR after standard chemotherapy;
  • The first induction reaches CR, but CR ≤ 12 months;
  • Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;

c.Multiple recurrences.

  • 3\. CD5 expression rate was >90%;
  • 4\. Number of blasts in the bone marrow (protolychic + larvae) >5% (morphology) and/or >1% (flow cytometry);
  • 5\. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
  • 6\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
  • 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);
  • 8.Estimated life expectancy of minimum of 12 weeks;
  • 9.ECOG 0-2;
  • 10.Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
  • 11\. Those who voluntarily participated in this trial and provided informed consent;

Exclusion criteria

  • 1.Patients with the history of epilepsy or other CNS disease;
  • 2\. Patients with prolonged QT interval time or severe heart disease;
  • 3\. Active infection of hepatitis B virus, C virus or hepatitis E virus;
  • 4\. Active infection with no cure;
  • 5\. Before using any gene therapy products;
  • 6\. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:
  • treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone < 10 mg/d or an equivalent dose of the drug);
  • received within 72 hours of small molecule targeted therapy;
  • 2 weeks received systemic chemotherapy except (pretreatment);
  • four weeks received radiotherapy;
  • 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  • 8\. Any unsuitable to participate in this trial judged by the investigator;
  • 9\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The first affiliated hospital of medical college of zhejiang university — Hangzhou

Identifiers

NCT: NCT06633354 · TXB2024014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗