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

ConditionT-Acute Lymphoblastic Leukemia
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-ALL

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD5 CAR T-cells

    Biological/Vaccine

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Administration of CD5+ T-ALL 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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