A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL

Recruiting now · Early Phase 1

Conditions studied: Acute Lymphoblastic Leukemia, Non-hodgkin Lymphoma,B Cell

In brief

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.

Key facts

Study ID

NCT04532268

Run by

Zhejiang University

People needed

72

Starts

2020-08-23

Expected to finish

2026-08-23

Last updated by the study team

2020-08-31

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 CD19+ 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 following conditions):
• CR not achieved after standardized chemotherapy;
• CR achieved following the first induction, but CR duration is less 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 flow cytometry);
• 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 WHO Classification Criteria for Lymphoma (2016);
• Relapsed or refractory B-NHL (meeting one of the following conditions):
• No response or relapse after second-line or above chemotherapy 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:
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
• No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 2;
• Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

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 urinary tract infection and 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, or bilirubin>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 of patients 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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