🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04532203
Recruiting Phase EARLY_PHASE1

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

NCT04532203 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Phase EARLY_PHASE1
Started
2020-11-01
Last updated
2020-10-26

Condition(s) studied

Acute Lymphoblastic LeukemiaNon-Hodgkin's Lymphoma

Investigational drug(s) / intervention(s)

CAR-T cellsOmmaya Reservoir

CAR-T cells: Each subject receive CAR T-cells by intravenous infusion

Ommaya Reservoir: Surgical catheter placement into the fourth ventricle of the brain

Study summary

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

Eligibility

Sex
ALL
Min age
3 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Inclusion criteria only for B-ALL: 1. Male or female aged 3-70 years; 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; * Inclusion criteria only for B-NHL: 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; * Common inclusion criteria for B-ALL and B-NHL: 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: Subjects with any of the following exclusion criteria were not eligible for this trial: 1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital,College of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting

More Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04532203 on ClinicalTrials.gov ↗ ← All trials in China