A Phase 2 Study of the Efficacy and Safety of a Dose of Donor-Derived CD19-targeted CAR T cells for children and young adults (up to 39 years old) with recurrent or persistent CD19 (+) Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516091-15-00

Acronym

ELPIDA-ALLOCART-01

Enrollment

Registered

2024-11-22

Start date

2022-11-23

Completion date

Unknown

Last updated

2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed Acute Leukemia

Brief summary

Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion. DDCART-CD19 product purity and Transduction Efficiency Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion

Detailed description

Duration of DDCART cell detection in patients' blood Duration of B-cell aplasia Correlation of DDCART cell and B-cells detection with disease relapse

Interventions

DRUGFLUDARABINE PHOSPHATE

DRUGDDCART‐CD19

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion. DDCART-CD19 product purity and Transduction Efficiency Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion	—

Secondary

Measure	Time frame
Duration of DDCART cell detection in patients' blood Duration of B-cell aplasia Correlation of DDCART cell and B-cells detection with disease relapse	—

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026