NCT04430530

4SCAR-T Therapy Post CD19-targeted Immunotherapy

Status unknown Phase 1, PHASE2 Last updated 12 June 2020

What this trial tests

Phase 1, PHASE2 trial testing Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20 in CD19 Negative B-cell Malignancies in 100 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
31 May 2023

31 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	1 June 2020
Primary completion	31 May 2023
Estimated completion	31 December 2023
Sites	3 locations across China

Drugs / interventions tested

• Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20 — full drug profile →

Conditions studied

• CD19 Negative B-cell Malignancies — all drugs for CD19 Negative B-cell Malignancies →

Sponsor

Shenzhen Geno-Immune Medical Institute

Who can join

Adults 6 Months to 75, any sex, with CD19 Negative B-cell Malignancies. 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 (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation 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. Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
   Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
2. Large-Scale Production of Lentiviral Vectors: Current Perspectives and Challenges.
   Martínez-Molina E, Chocarro-Wrona C, Martínez-Moreno D, Marchal JA, et al · · 2020 · cited 55× · PMID 33153183 · DOI 10.3390/pharmaceutics12111051
3. Targeting CD22 for the Treatment of B-Cell Malignancies.
   Shah NN, Sokol L. · · 2021 · cited 42× · PMID 34262884 · DOI 10.2147/itt.s288546
4. Facts and Challenges in Immunotherapy for T-Cell Acute Lymphoblastic Leukemia.
   Bayón-Calderón F, Toribio ML, González-García S. · · 2020 · cited 42× · PMID 33081391 · DOI 10.3390/ijms21207685
5. Novel antigens of CAR T cell therapy: New roads; old destination.
   Safarzadeh Kozani P, Safarzadeh Kozani P, Rahbarizadeh F. · · 2021 · cited 31× · PMID 33862524 · DOI 10.1016/j.tranon.2021.101079
6. Next-generation chimeric antigen receptors for T- and natural killer-cell therapies against cancer.
   Li Y, Rezvani K, Rafei H. · · 2023 · cited 29× · PMID 37548050 · DOI 10.1111/imr.13255
7. 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
8. 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