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CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

ConditionsAcute Myeloid LeukemiaNon-hodgkin's LymphomaMultiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZhejiang University

About this trial

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);

CR not achieved after standardized chemotherapy;

CR achieved following the first induction, but CR duration is less than 12 months;

Ineffectively after first or multiple remedial treatments;

Disqualifiers

History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

Pregnant (or lactating) women;

Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);

Trial design

Design model

Single group

Treatments tested in this trial

  • CD70 CAR T-cells

    Biological/Vaccine

    Each subject receive CD70 CAR T-cells by intravenous infusion

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: T-ALLExperimental treatment 1 intervention
Group B: T-NHLExperimental treatment 1 intervention
Group C: AMLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

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

Time frame
Baseline up to 28 days after CD70 targeted CAR T-cells infusion
2

Incidence of treatment-emergent adverse events (TEAEs)

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

Time frame
Up to 2 years after CD70 targeted CAR T-cells infusion

Secondary outcomes

1

Acute Myeloid Leukemia (AML), Overall response rate (ORR)

Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24

Time frame
At Month 1, 3, 6, 12, 18 and 24
2

AML, Overall survival (OS)

From the first infusion of CD70 CAR-T cells to death or the last visit

Time frame
Up to 2 years after CD70 CAR-T cells infusion
3

AML, Event-free survival (EFS)

From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

Time frame
Up to 2 years after CD70 CAR-T cells infusion
4

Non-Hodgkin's lymphoma (NHL), Overall response rate (ORR)

Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24

Time frame
At Month 1, 3, 6, 12, 18 and 24

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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