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

ConditionT-lymphoblastic Lymphoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. According to the 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL),

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD5 CAR T-cells

    Biological/Vaccine

    Each subject receive CD5+ T-lymphoma Targeted CAR T-cells by intravenous infusion

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Administration of CD5+ T-lymphoma Targeted CAR T-cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time frame
Up to 28 days after Treatment
2

Incidence of treatment-emergent adverse events (TEAEs)

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Time frame
Up to 2 years after Treatment

Secondary outcomes

1

Overall response rate ,ORR

The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).

Time frame
Up to 12 weeks after CAR-T infusion
2

Duration of remission ,DOR

The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion

Time frame
Up to 1 years after CAR-T infusion
3

Progression Free Survival, PFS

The time from randomization or start of study treatment until objective tumor progression or death

Time frame
Up to 2 years after Treatment
4

Overall survival, OS

The time from CAR-T infusion to death due to any cause

Time frame
Up to 1 years after CAR-T infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov
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