NCT03321123

MB-CART19.1 in Patients With R/R ALL

Status unknown Phase 2 Last updated 25 October 2017

What this trial tests

Phase 2 trial testing MB-CART19.1 in Precursor B-Lymphoblastic Lymphoma/Leukaemia Refractory in 10 participants. Status unknown.

Timeline

1 December 2017

Primary endpoint
1 July 2019

31 December 2019

Quick facts

Lead sponsor	Shanghai Children's Medical Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 December 2017
Primary completion	1 July 2019
Estimated completion	31 December 2019

Drugs / interventions tested

• MB-CART19.1 — full drug profile →

Conditions studied

• Precursor B-Lymphoblastic Lymphoma/Leukaemia Refractory — all drugs for Precursor B-Lymphoblastic Lymphoma/Leukaemia Refractory →

Sponsor

Shanghai Children's Medical Center

Who can join

Adults 2 Months to 18, any sex, with Precursor B-Lymphoblastic Lymphoma/Leukaemia Refractory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Precursor-B acute lymphoblastic leukemia (ALL) is the most common cancer in childhood. Despite major advances in ALL therapy, 20% of children and 40-50% of adults fail state-of-the art first-line treatment. But there is a strong need for alternative treatments to cure chemotherapy-refractory and relapsed B cell malignancies in pediatric patients. Relapsed and refractory B cell malignancies remain a therapeutic challenge, as these diseases are characterized by adverse survival. These cancers share a cell origin from the B-cell lineage and consequent surface expression of B-lineage markers such as CD19 and CD22. Chimeric antigen receptor (CAR) engineered T cell therapy has recently emerged as a new modality to target B cell malignancies. CARs couple a single-chain Fv (scFv) domain directed against a B-lineage-specific antigen to T-cell activating intracellular signaling domains. CAR gene-modified T cell interaction with target cells occurs in a HLA-independent fashion, so that a single vector can be used to treat all patients with cancers that express the target antigen. Miltenyi Biotec has established a semi-automated manufacturing process that can be made available to academic settings for systematic exploration of CAR strategies in advanced clinical studies. Closed-system operation, improved robustness, simplified work flows, and reduced labor intensity, while maintaining strict adherence to regulatory guidelines, allows for decentralized manufacturing. In the proposed phase II study, the investigator will explore autologous 2nd generation CD19 CAR T cell products in patients with relapsed and refractory disease incurable with standard therapies.

Publications & conference data

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

1. The future of cellular immunotherapy for childhood leukemia.
   Bonifant CL, Tasian SK. · · 2020 · cited 15× · PMID 31851053 · DOI 10.1097/mop.0000000000000866
2. [How I manage relapsed/refractory B-cell acute lymphoblastic leukemia patients treated with CD19 CAR- T cells throughout whole-process management].
   Wang Y. · · 2025 · PMID 41486655 · DOI 10.3760/cma.j.cn121090-20250910-00419