Health Trials

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

ConditionsRelapsed or Refractory B-cell Acute Lymphoblastic LeukemiaNon-Hodgkin's Lymphoma RefractoryNon-Hodgkin's Lymphoma, Relapsed
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitute of Hematology and Blood Transfusion, Czech Republic

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Autologous CAR19 T lymphocytes

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Institute of Hematology and Blood Transfusion, Czech Republic

Lead sponsor

Source ClinicalTrials.gov