NCT04173988

Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Status unknown EARLY_PHASE1 Last updated 15 March 2024

What this trial tests

EARLY_PHASE1 trial testing alloCART-19 in ALL, Childhood B-Cell in 6 participants. Status unknown.

Timeline

9 January 2020

Primary endpoint
20 October 2024

20 July 2025

Quick facts

Lead sponsor	Children's Hospital of Fudan University
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	9 January 2020
Primary completion	20 October 2024
Estimated completion	20 July 2025
Sites	1 location across China

Drugs / interventions tested

• alloCART-19
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →

Conditions studied

• ALL, Childhood B-Cell — all drugs for ALL, Childhood B-Cell →

Sponsor

Children's Hospital of Fudan University

Who can join

Adults 1 to 18, any sex, with ALL, Childhood B-Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of CD19-Directed Allogeneic Chimeric Antigen Receptor T- cell (alloCART-19)therapy in pediatric patients with relapsed/refractory acute lymphoblastic leukemia（ALL）.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of Cell and Genome Modification Technologies to Generate Improved "Off-the-Shelf" CAR T and CAR NK Cells.
   Morgan MA, Büning H, Sauer M, Schambach A. · · 2020 · cited 113× · PMID 32903482 · DOI 10.3389/fimmu.2020.01965
2. Allogeneic CAR Cell Therapy-More Than a Pipe Dream.
   Caldwell KJ, Gottschalk S, Talleur AC. · · 2020 · cited 98× · PMID 33488631 · DOI 10.3389/fimmu.2020.618427
3. Recent updates on allogeneic CAR-T cells in hematological malignancies.
   Mansoori S, Noei A, Maali A, Seyed-Motahari SS, et al · · 2024 · cited 34× · PMID 39227937 · DOI 10.1186/s12935-024-03479-y
4. Current Perspectives on the Use of off the Shelf CAR-T/NK Cells for the Treatment of Cancer.
   Cutmore LC, Marshall JF. · · 2021 · cited 22× · PMID 33923528 · DOI 10.3390/cancers13081926
5. Chimeric Antigen Receptor T-Cell Therapy in Paediatric B-Cell Precursor Acute Lymphoblastic Leukaemia: Curative Treatment Option or Bridge to Transplant?
   Buechner J, Caruana I, Künkele A, Rives S, et al · · 2021 · cited 20× · PMID 35145941 · DOI 10.3389/fped.2021.784024
6. Immune Microenvironment in Childhood Cancers: Characteristics and Therapeutic Challenges.
   Pathania AS. · · 2024 · cited 9× · PMID 38927907 · DOI 10.3390/cancers16122201
7. Is It Possible to Separate the Graft-Versus-Leukemia (GVL) Effect Against B Cell Acute Lymphoblastic Leukemia From Graft-Versus-Host Disease (GVHD) After Hematopoietic Cell Transplant?
   Rozmus J, Bhatt ST, Buxbaum NP, Cuvelier GDE, et al · · 2022 · cited 4× · PMID 35402356 · DOI 10.3389/fped.2022.796994
8. [Universal chimeric antigen receptor T cells therapy: current status and future perspectives].
   Huang Y, Hu KJ, Hu YX, Huang H. · · 2021 · cited 1× · PMID 34753238 · DOI 10.3760/cma.j.issn.0253-2727.2021.09.015