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

Early Phase 1

Recruiting

• Conditions: T-lymphoblastic Lymphoma
• Interventions: Biological: CD5 CAR T-cells

• Registration Number: NCT06633341
• Lead Sponsor: Zhejiang University

Brief Summary

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Study Start: 2024-10-20
• Primary Completion: 2027-10-20
• Study Completion: 2027-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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) :

1. Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;

2. Primary drug resistance;

3. 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:

  7. 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);

  8. received within 72 hours of small molecule targeted therapy;

  9. 2 weeks received systemic chemotherapy except (pretreatment);

  10. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of CD5+ T-lymphoma Targeted CAR T-cells	CD5 CAR T-cells	Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Up to 28 days after Treatment	Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)	Up to 2 years after Treatment	Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Secondary Outcome Measures

Name	Time	Method
Overall response rate ,ORR	Up to 12 weeks after CAR-T infusion	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Duration of remission ,DOR	Up to 1 years after CAR-T infusion	The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Progression Free Survival, PFS	Up to 2 years after Treatment	The time from randomization or start of study treatment until objective tumor progression or death
Overall survival, OS	Up to 1 years after CAR-T infusion	The time from CAR-T infusion to death due to any cause

Trial Locations

Locations (1)

The first affiliated hospital of medical college of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China