A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies
NCT ID: NCT04532281
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
120 participants
INTERVENTIONAL
2020-11-01
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of Murine CD19 CAR T-cells
Murine CD19 CAR-T cells
Each subject receive murine CD19 CAR T-cells by intravenous infusion
Interventions
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Murine CD19 CAR-T cells
Each subject receive murine CD19 CAR T-cells by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
1. CR not achieved after standardized chemotherapy;
2. CR achieved following the first induction, but CR duration is less than 12 months;
3. Ineffectively after first or multiple remedial treatments;
4. 2 or more relapses;
3. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \> 5% (by morphology), and/or \> 1% (by flow cytometry);
4. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
1. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
2. Relapsed or refractory B-NHL (meeting one of the following conditions):
1. No response or relapse after second-line or above chemotherapy regimens;
2. Primary drug resistance;
3. Relapse after auto-HSCT;
3. At least one assessable tumor lesion per Lugano 2014 criteria;
1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
4. Estimated survival time ≥ 3 months;
5. ECOG performance status 0 to 2;
6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tractinfectionand bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Clinical Professor
Locations
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The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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mCD19-002
Identifier Type: -
Identifier Source: org_study_id