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

NCT05054257 | Recruiting Phase 1 DMC

• 2 other identifiers: UHKT-CAR19-012018-004789-32
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma Refractory; Non-Hodgkin's Lymphoma, Relapsed

Keywords

B Cell; ALL; Relapsed or Refractory; B-NHL; Leukemia; Chimeric antigen receptor; CAR; CAR T cell

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Cumulative incidence of IMP-related adverse events (AEs) graded by ASTCT consensus grading criteria for Cytokine Release Syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) and by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 for other AEs. Toxicities will be followed from the start of Blood Collection or Apheresis until the end of the study.

  Up to 2 years post treatment

• Assessment of Dose-Limiting Toxicities (DLTs)

  Incidence of Dose-limiting toxicities (DLTs) during the first 28 days after IMP administration

  Up to 28 days after IMP administration

Secondary Outcomes (3)

• Complete remission ( CR) rate

  CR rate at 100 days and 6 months after IMP administration

• Overall Survival

  OS at 1 year after IMP administration

• Quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30).

  At 6 months and 1 year following IMP administration

Other Outcomes (1)

• CART19 cells in peripheral blood, bone marrow and cerebrospinal fluid

  Up to 24 months

Study Arms (1)

Autologous CAR19 T lymphocytes

EXPERIMENTAL

Human Autologous T Lymphocytes Expressing the Chimeric Antigen Receptor Specific to CD19

Drug: Autologous CAR19 T lymphocytes

Interventions

Autologous CAR19 T lymphocytes DRUG

First-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL

Autologous CAR19 T lymphocytes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Institute of Hematology and Blood Transfusion, Czech Republic: lead

Study Sites (1)

Institute of Hematology and Blood Transfusion, Czech Republic

Prague, 12800, Czechia

RECRUITING

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MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma; Lymphoma, Non-Hodgkin; Leukemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Petr Lesny

  Institute of Hematology and Blood Transfusion, Czech Republic

  STUDY CHAIR

• Jan Vydra

  Institute of Hematology and Blood Transfusion, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Vydra

CONTACT

+420221977182; jan.vydra@uhk.cz

Petr Lesny

CONTACT

+420221977629; petr.lesny@uhkt.cz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: September 23, 2021
• Study Start: June 2, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 12, 2025
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)