CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Recruiting now · Phase 1

Conditions studied: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma Refractory, Non-Hodgkin's Lymphoma, Relapsed

In brief

Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.

Key facts

Study ID

NCT05054257

Run by

Institute of Hematology and Blood Transfusion, Czech Republic

People needed

10

Starts

2021-06-02

Expected to finish

2025-12-12

Last updated by the study team

2025-01-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:
• B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR
• B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR
• B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).
• CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
• Age ≥18 years and ≤ 80 yearss.
• Patient able to understand and sign informed consent.
• Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.
• General Exclusion Criteria:
• Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).
• Autologous or allogeneic HCT in 3 months prior to IMP administration.
• Severe, uncontrolled active infection.
• Life expectancy < 6 weeks.
• Parenchymal central nervous system involvement.
• Respiratory insufficiency (need for oxygen therapy).
• Significant liver impairment: bilirubin > 50 µmol/L, AST or ALT > 4times normal upper limit.
• Acute kidney injury with serum creatinine > 180 µmol/L, oliguria or need for acute dialysis.
• Heart failure with EF < 30% by echocardiography.
• Presence of active grade 3-4 acute GvHD.
• Serious uncontrolled neurological comorbidity.
• Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.
• Women: pregnancy or breast-feeding.
• Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:
• female patients of childbearing potential not willing to use a highly effective method of contraception during the study,
• male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.

Where it is running

• Institute of Hematology and Blood Transfusion, Czech Republic — Prague, Czechia (enrolling)

Full record on ClinicalTrials.gov

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