Recruiting NCT06633341

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

Early Phase I Interventional T-lymphoblastic Lymphoma

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-lymphoblastic Lymphoma. 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 →

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Official title

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

Overview

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

Detailed description

In this study, 30 patients with relapsed refractory T-lymphoma 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-lymphoma; 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-lymphoma were accumulated.

Interventions

Biological CD5 CAR T-cells
Each subject receive CD5+ T-lymphoma 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 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL),

R/R T-NHL(meets one of the following conditions) :

Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;
Primary drug resistance;
Relapse after autologous hematopoietic stem cell transplantation;

2.CD5 expression rate was >90%;
3\. According to Lugano 2014, there should be at least one evaluable tumor lesion;
4\. 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);
5\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
6\. Refers to the pulse oxygen saturation 92% or higher oxygen (state);
7\. Estimated life expectancy of minimum of 12 weeks;
8\. ECOG 0-2;
9\. 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;
10\. Those who voluntarily participated in this trial and provided informed consent;

Exclusion criteria

1\. History of epilepsy or other central nervous system disorders;
2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3\. Active infection of hepatitis B virus, C virus or hepatitis E virus;
4\. Active infected persons who are not cured;
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: NCT06633341 · TXB2024013

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗