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

Recruiting now · Early Phase 1

Conditions studied: Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma

In brief

Key facts

Study ID: NCT04532203
Run by: Zhejiang University
People needed: 72
Starts: 2020-11-01
Expected to finish: 2026-11-01
Last updated by the study team: 2020-10-26

Who can join

Age: 3 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Inclusion criteria only for B-ALL:
Male or female aged 3-70 years;
Histologically confirmed diagnosis of 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 followingconditions):
CR not achieved after standardized chemotherapy;
CR achieved following the first induction, but CR duration isless than 12 months;
Ineffectively after first or multiple remedial treatments;
2 or more relapses;
The number of primordial cells (lymphoblast and prolymphocyte)in bone marrow is>5% (by morphology), and/or >1% (by flowcytometry);
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:
Male or female aged 18-75 years;
Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHOClassification Criteria for Lymphoma (2016);
Relapsed or refractory B-NHL (meeting one of the followingconditions):
No response or relapse after second-line or abovechemotherapy regimens;
Primary drug resistance;
Relapse after auto-HSCT;
At least one assessable tumor lesion per Lugano 2014 criteria;
Common inclusion criteria for B-ALL and B-NHL:
Highly suspected or confirmed central nervous system involvement of hematological malignancies;
Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
Estimated survival time ≥ 3 months;
ECOG performance status 0 to 2;

You may not qualify if…

Subjects with any of the following exclusion criteria were not eligible for this trial:
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 urinarytractinfectionand 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 inhaled 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,orbilirubin>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 ofpatients or interfere with the results of study.

Where it is running

The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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