A Phase 2 Study of the Efficacy and Safety of a Dose of Donor-Derived CD19-targeted CAR T cells

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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003445-37-GR

Enrollment

Registered

2022-09-15

Start date

2021-09-30

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Relapsed b Acute Lymphoblastic Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation MedDRA version: 20.1 Level: PT Classification code 10063620 Term: Acute lymphocytic leukaemia recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: DDCAR-CD19 T-cells Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Individuals between 6 months and 39 years of age who have recurrent or persistent CD19 (+) acute leukemia after allogeneic HSCT or following autologous CAR-T cell therapy - =5 X 10-4 CD19+ blast cells in bone marrow as determined per flow cytometry, or isolated extramedullary relapse. - No evidence of = grade II aGVHD or chronic GVHD while off of systemic immunosuppressive therapy for at least 4 weeks. - Lansky (age =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Active severe infection Active aGVHD Grade =II <30% expression of CD19 on the leukemic population Presence of a CD19-negative leukemic subclone Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids Eligible for therapy with recipient-derived CAR-T cells

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of the infusion of DDCAR-CD19 cells To evaluate the incidence of aGVHD and cGVHD. To determine both quantitatively and qualitatively the generation of CAR-T cells using the CliniMACS Prodigy device. ;Secondary Objective: To evaluate the duration of in vivo persistence of adoptively transferred DDCAR-CD19 cells. To evaluate B-cell aplasia. ;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 1, 6, 12, and 24 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of the infusion of DDCAR-CD19 cells To evaluate the incidence of aGVHD and cGVHD. To determine both quantitatively and qualitatively the generation of CAR-T cells using the CliniMACS Prodigy device. ;Secondary Objective: To evaluate the duration of in vivo persistence of adoptively transferred DDCAR-CD19 cells. To evaluate B-cell aplasia. ;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 1, 6, 12, and 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): Duration of DDCART cell detection in patients’ blood Duration of B-cell aplasia Correlation of DDCART cell and B-cells detection with disease relapse ;Timepoint(s) of evaluation of this end point: 3, 6, 12, 18 and 24 months	—

Countries

Greece

Contacts

Public ContactEvgenios Goussetis

Aghia Sophia Children’s Hospital

evgoussetis@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026