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CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.

NCT05054257•Institute of Hematology and Blood Transfusion, Czech Republic

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is an open-label, single arm study on up to 24 adult subjects with refractory or relapsed CD19+ Non-Hodgkin's Lymphoma or B-ALL. Following lymphodepleting conditioning regimen, the patients will receive a single dose of autologous CAR19 T lymphocytes provided by the sponsor´s manufacturing facility. CART19 dose will be escalated in consecutive patients using accelerated titration design in order to establish recommended CART19 dose for further study, which will be either Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD), whichever is reached first.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:
•1. B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR
•2. B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR
•3. B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).
•2. CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
•3. Age ≥18 years and ≤ 80 yearss.
•4. Patient able to understand and sign informed consent.
•5. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.

Exclusion Criteria

•1. Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).
•2. Autologous or allogeneic HCT in 3 months prior to IMP administration.
•3. Severe, uncontrolled active infection.
•4. Life expectancy \< 6 weeks.
•5. Parenchymal central nervous system involvement.
•6. Respiratory insufficiency (need for oxygen therapy).
•7. Significant liver impairment: bilirubin \> 50 µmol/L, AST or ALT \> 4times normal upper limit.
•8. Acute kidney injury with serum creatinine \> 180 µmol/L, oliguria or need for acute dialysis.
•9. Heart failure with EF \< 30% by echocardiography.
•10. Presence of active grade 3-4 acute GvHD.
+29 more criteria

Locations (1)

Institute of Hematology and Blood Transfusion, Czech Republic

Prague, Czechia

Key Dates

Start Date

June 2, 2021

Primary Completion Date

June 1, 2025

Completion Date

December 12, 2025

Last Updated

January 6, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory B-cell Acute Lymphoblastic LeukemiaNon-Hodgkin's Lymphoma RefractoryNon-Hodgkin's Lymphoma, Relapsed

Interventions

Autologous CAR19 T lymphocytes

DRUG

Contacts

Jan Vydra

CONTACT

+420221977182 jan.vydra@uhk.cz

Petr Lesny

CONTACT

+420221977629 petr.lesny@uhkt.cz

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL

NCT04690595

Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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