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)
Dose-limiting toxicity (DLT) — Baseline up to 28 days after CAR T-cells infusion Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years after CAR T-cells infusion Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital,College of Medicine, Zhejiang University
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.
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