drugset
Drugs / SYNCAR-001
last change Apr 2025 re-read 3 minutes ago

SYNCAR-001

Cell therapy targets CD19

Developed for
chronic lymphocytic leukemia/small lymphocytic lymphoma · diffuse large B-cell lymphoma · follicular lymphoma · large B-cell lymphoma · lupus nephritis · mantle cell lymphoma · systemic lupus erythematosus · systemic sclerosis
Investigated by
Synthekine

Trials 2

today NCT06544330 · Ph 1 NCT05665062 · Ph 1
20242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT06544330 Apr 2025 → Apr 2028 expected lupus nephritis, systemic lupus erythematosus, systemic sclerosis Synthekine Active not recruiting No outcome recorded
Phase 1 NCT05665062 Apr 2023 → Jun 2028 expected chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, large B-cell lymphoma +1 Synthekine Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2024-12-09 Synthekine Results Synthekine Presents Positive Initial Results from Phase 1 Clinical Trial of CD19 CAR-T (SYNCAR-001) and Orthogonal IL-2 (STK-009) Combination Therapy for Treatment of Hematologic Malignancies at ASH 2024 Annual Meeting synthekine.com ↗
This regimen also demonstrated durable responses, including complete responses in all 4 patients with non-Hodgkin lymphoma (NHL).
2024-11-15 Synthekine Results Synthekine to Present Preclinical Data for CD19 CAR-T (SYNCAR-001) Empowered by Orthogonal IL-2 (STK-009) Without Lymphodepletion at American College of Rheumatology (ACR) Convergence 2024 synthekine.com ↗
2024-09-04 Synthekine Regulatory Synthekine Granted U.S. FDA Fast Track Designation for CD19 CAR-T and Orthogonal IL-2 Investigational Therapy, SYNCAR-001 + STK-009, for the Treatment of Lupus Without Lymphodepletion synthekine.com ↗
Fast Track designation follows Investigational New Drug (IND) clearance for a Phase 1 study evaluating SYNCAR-001 + STK-009 for non-renal systemic lupus erythematosus (SLE) and lupus nephritis (LN)
2024-03-20 Synthekine Regulatory Synthekine Announces U.S. FDA Clearance of IND Application for CD19 CAR-T and Orthogonal IL-2 Combination Therapy, SYNCAR-001 + STK-009, for Treatment of Lupus Without Lymphodepletion synthekine.com ↗
2021-12-23 Synthekine Results Synthekine Announces Publication of Preclinical Data Demonstrating In Vivo Control of CD19 CAR-T Cells with its Orthogonal IL-2 System synthekine.com ↗
The published data shows STK-009, the orthogonal IL-2 ligand, enables the control of cell expansion and activation of a CD19 CAR-T cell therapy which expresses the orthogonal IL-2 receptor (SYNCAR-001) in preclinical models of human lymphoma.
2021-11-16 Synthekine Results Synthekine Presents Data at AACR Annual Meeting 2021 Demonstrating Selective IL-2 Partial Agonist, STK-012, Promotes Anti-Tumor Response without Related Toxicities synthekine.com ↗
Synthekine also presented new data on its orthogonal IL-2 and CD-19 CAR-T system (STK-009 and SYNCAR-001).
2021-11-16 Synthekine Results Synthekine Presents Data at American Society of Hematology Annual Meeting Showing Orthogonal IL-2 Ligand Drives Deeper and More Durable Response of CD-19 CAR-T synthekine.com ↗
In both disseminated and subcutaneous RAJI lymphoma models in mice evaluating the efficacy of STK-009 with SYNCAR-001, STK-009 dosing drove increased levels of circulating SYNCAR-001 cells, resulting in complete responses.

All press releases naming this drug 8 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SYNCAR-001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06544330 ↗
1

NCT05665062 ↗
Modality Cell therapy “SYNCAR-001, a CD19-directed chimeric antigen receptor T cell (CAR-T) co-expressing an engineered IL-2 beta receptor (hoRb)” NCT05665062 ↗
Route Intravenous “A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered” NCT05665062 ↗
Target CD19 “SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb” NCT05665062 ↗