A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies
Clinical Trial for the Safety and Efficacy of Murine CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
1 other identifier
interventional
120
1 country
1
Brief Summary
A Study of Murine CD19 CAR-T Cells Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Nov 2020
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedOctober 26, 2020
October 1, 2020
3 years
August 20, 2020
October 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Baseline up to 28 days after murine CD19 targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Up to 2 years after murine CD19 targeted CAR T-cells infusion
Secondary Outcomes (9)
B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)
At Month 1, 3, 6, 12, 18 and 24
B-ALL, Overall survival (OS)
Up to 2 years after murine CD19 CAR-T cells infusion
B-ALL, Event-free survival (EFS)
Up to 2 years after murine CD19 CAR-T cells infusion
B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)
At Week 4, 12, and Month 6, 12, 18, 24
B-NHL, disease control rate (DCR)
At Week 12 and Month 6, 12, 18, 24
- +4 more secondary outcomes
Study Arms (1)
Administration of Murine CD19 CAR T-cells
EXPERIMENTALInterventions
Each subject receive murine CD19 CAR T-cells by intravenous infusion
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1)；
- Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
- 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;
- or more relapses;
- The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \> 5% (by morphology), and/or \> 1% (by flow cytometry);
- Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
- Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
- Relapsed or refractory B-NHL (meeting one of the following conditions):
- No response or relapse after second-line or above chemotherapy regimens;
- Primary drug resistance;
- Relapse after auto-HSCT;
- At least one assessable tumor lesion per Lugano 2014 criteria;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- +5 more criteria
You may not qualify if:
- 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 tractinfectionand bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- Yake Biotechnology Ltd.collaborator
Study Sites (1)
The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 31, 2020
Study Start
November 1, 2020
Primary Completion
November 1, 2023
Study Completion (Estimated)
November 1, 2026
Last Updated
October 26, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share