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A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL

ConditionsAcute Lymphoblastic LeukemiaNon-hodgkin Lymphoma,B Cell
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-75
SponsorZhejiang University

About this trial

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged 3-70 years;

Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);

CR not achieved after standardized chemotherapy;

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

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

  • Humanized CD19 CAR-T cells

    Drug

    Each subject receive humanized CD19 CAR T-cells by intravenous infusion

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: Administration of Humanized CD19 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
Baseline up to 28 days after humanized CD19 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 humanized CD19 targeted CAR T-cells infusion

Secondary outcomes

1

B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)

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

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

B-ALL, Overall survival (OS)

From the first infusion of humanized CD19 CAR-T cells to death or the last visit

Time frame
Up to 2 years after humanized CD19 CAR-T cells infusion
3

B-ALL, Event-free survival (EFS)

From the first infusion of humanized CD19 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 humanized CD19 CAR-T cells infusion
4

B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)

Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria

Time frame
At Week 4, 12, and Month 6, 12, 18, 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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