NCT04016129

CAR-T Immunotherapy Targeting CD19- ALL

Status unknown Phase 1, PHASE2 Last updated 19 September 2019

What this trial tests

Phase 1, PHASE2 trial testing 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR in B-cell Leukemia in 100 participants. Status unknown.

Timeline

15 July 2019

Primary endpoint
15 July 2021

15 December 2023

Quick facts

Lead sponsor	Shenzhen Geno-Immune Medical Institute
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	15 July 2019
Primary completion	15 July 2021
Estimated completion	15 December 2023
Sites	3 locations across China

Drugs / interventions tested

• 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR — full drug profile →

Conditions studied

• B-cell Leukemia — all drugs for B-cell Leukemia →

Sponsor

Shenzhen Geno-Immune Medical Institute

Who can join

Adults 6 Months to 75, any sex, with B-cell Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Publications & conference data

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

1. Current Progress in CAR-T Cell Therapy for Hematological Malignancies.
   Han D, Xu Z, Zhuang Y, Ye Z, et al · · 2021 · cited 119× · PMID 33391429 · DOI 10.7150/jca.48976
2. Targeting CD22 for the Treatment of B-Cell Malignancies.
   Shah NN, Sokol L. · · 2021 · cited 42× · PMID 34262884 · DOI 10.2147/itt.s288546
3. Bispecific Chimeric Antigen Receptor T Cell Therapy for B Cell Malignancies and Multiple Myeloma.
   Cronk RJ, Zurko J, Shah NN. · · 2020 · cited 42× · PMID 32899464 · DOI 10.3390/cancers12092523
4. CAR-T therapy: Prospects in targeting cancer stem cells.
   Cui X, Liu R, Duan L, Cao D, et al · · 2021 · cited 29× · PMID 34585512 · DOI 10.1111/jcmm.16939
5. CAR-T cell therapy for hematological malignancies: History, status and promise.
   Wang C, Wang J, Che S, Zhao H. · · 2023 · cited 25× · PMID 38027932 · DOI 10.1016/j.heliyon.2023.e21776
6. Synthetic Biology in the Engineering of CAR-T and CAR-NK Cell Therapies: Facts and Hopes.
   Clubb JD, Gao TA, Chen YY. · · 2023 · cited 24× · PMID 36454122 · DOI 10.1158/1078-0432.ccr-22-1491
7. Targeting CD38 for acute leukemia.
   Zhong X, Ma H. · · 2022 · cited 15× · PMID 36313735 · DOI 10.3389/fonc.2022.1007783
8. The future of cellular immunotherapy for childhood leukemia.
   Bonifant CL, Tasian SK. · · 2020 · cited 15× · PMID 31851053 · DOI 10.1097/mop.0000000000000866