CART19 cells effects in patients with relapsed/refractory acute lymphoblastic leukemia and non-Hodgkin lymphoma.

Phase 1

Recruiting

• Conditions: Relapsed/refractory CD19+ Acute Lymphoblastic Leukaemia and Non-Hodgkin Lymphoma
• Interventions: Drug: Autologous CAR19 T lymphocytes

• Registration Number: 2024-510815-30-00
• Lead Sponsor: Institute Of Hematology And Blood Transfusion

Brief 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.

Study Timeline

• Study First Posted: 2024-07-23
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous CAR19 T lymphocytes	Autologous CAR19 T lymphocytes	Human Autologous T Lymphocytes Expressing the Chimeric Antigen Receptor Specific to CD19

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 2 years post treatment	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.
Assessment of Dose-Limiting Toxicities (DLTs)	Up to 28 days after IMP administration	Incidence of Dose-limiting toxicities (DLTs) during the first 28 days after IMP administration

Secondary Outcome Measures

Name	Time	Method
Complete remission ( CR) rate	CR rate at 100 days and 6 months after IMP administration	Assessment of the efficacy of IMP cells administration in patients with refractory or relapsed CD19+ NHL and B-ALL evaluated by Complete Remission rate
Overall Survival	OS at 1 year after IMP administration	Assessment of the efficacy of IMP cells administration in patients with refractory or relapsed CD19+ NHL and B-ALL evaluated by Overall Survival
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	EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.

Trial Locations

Locations (1)

Institute Of Hematology And Blood Transfusion; 🇨🇿 Prague, Czechia

Institute Of Hematology And Blood Transfusion

🇨🇿Prague, Czechia

Jan Vydra

Site contact

+420221977182

Jan.Vydra@uhkt.cz