A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies
NCT ID: NCT04532203
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
72 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 CAR T-cells
Dose escalation follows the standard 3+3 doseescalation design. A total of 3 dose levels are set for subjects.
CAR-T cells
Each subject receive CAR T-cells by intravenous infusion
Ommaya Reservoir
Surgical catheter placement into the fourth ventricle of the brain
Interventions
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CAR-T cells
Each subject receive CAR T-cells by intravenous infusion
Ommaya Reservoir
Surgical catheter placement into the fourth ventricle of the brain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
3. Relapsed or refractory CD19+ B-ALL (meeting one of the followingconditions):
1. CR not achieved after standardized chemotherapy;
2. CR achieved following the first induction, but CR duration isless than 12 months;
3. Ineffectively after first or multiple remedial treatments;
4. 2 or more relapses;
4. The number of primordial cells (lymphoblast and prolymphocyte)in bone marrow is\>5% (by morphology), and/or \>1% (by flowcytometry);
5. 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. Male or female aged 18-75 years;
2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHOClassification Criteria for Lymphoma (2016);
3. Relapsed or refractory B-NHL (meeting one of the followingconditions):
1. No response or relapse after second-line or abovechemotherapy regimens;
2. Primary drug resistance;
3. Relapse after auto-HSCT;
4. At least one assessable tumor lesion per Lugano 2014 criteria;
1. Highly suspected or confirmed central nervous system involvement of hematological malignancies;
2. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
3. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
4. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
5. Estimated survival time ≥ 3 months;
6. ECOG performance status 0 to 2;
7. 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 urinarytractinfectionand 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 inhaled 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,orbilirubin\>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 ofpatients or interfere with the results of study.
3 Years
75 Years
ALL
No
Sponsors
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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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CNSL-ZhejiangU
Identifier Type: -
Identifier Source: org_study_id