NCT06613490 is a EARLY_PHASE1 clinical trial of anti CD19 CAR NK cells in Antisynthetase Syndrome, sponsored by The First Affiliated Hospital with Nanjing Medical University.

Who is sponsoring NCT06613490?

NCT06613490 is sponsored by The First Affiliated Hospital with Nanjing Medical University.

What drugs are being tested in NCT06613490?

Interventions in NCT06613490: anti CD19 CAR NK cells.

What condition does NCT06613490 study?

NCT06613490 studies Antisynthetase Syndrome, Rheumatoid Arthritis.

Is NCT06613490 still recruiting?

NCT06613490 is currently recruiting now. Last updated 30 April 2025.

Last reviewed 2025-04-30 · How we verify

NCT06613490

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis

Recruiting now EARLY_PHASE1 Last updated 30 April 2025

What this trial tests

EARLY_PHASE1 trial testing anti CD19 CAR NK cells in Antisynthetase Syndrome in 24 participants. Currently enrolling.

Timeline

20 May 2025

Primary endpoint
20 October 2025

20 October 2026

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	20 May 2025
Primary completion	20 October 2025
Estimated completion	20 October 2026
Sites	1 location across China

Drugs / interventions tested

anti CD19 CAR NK cells — full drug profile →

Conditions studied

Antisynthetase Syndrome — all drugs for Antisynthetase Syndrome →
Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 70, any sex, with Antisynthetase Syndrome or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A single-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.

Publications & conference data

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

The clinical landscape of CAR NK cells.
Jørgensen LV, Christensen EB, Barnkob MB, Barington T. · · 2025 · cited 61× · PMID 40149002 · DOI 10.1186/s40164-025-00633-8
Natural killer cells in adoptive cell therapy: current landscape of genetic engineering strategies.
Burón M, Etxebarria A, Álvarez M, Romayor I, et al · · 2025 · cited 4× · PMID 40996824 · DOI 10.1080/2162402x.2025.2563099
Research progress on chimeric antigen receptor-based immunotherapy against autoimmune diseases.
Jiang M, Zhao J, Yuan J, Yu Z, et al · · 2025 · cited 2× · PMID 40747591 · DOI 10.1080/21645515.2025.2538350

Verify or expand the search:

Other trials of anti CD19 CAR NK cells

Trials testing the same drug.

NCT06631040 — Cell Therapy with Anti-CD19 CAR-NK Cells in Patients with Relapsed or Resistant B-ALL · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Antisynthetase Syndrome

Currently open trials in the same condition.

NCT05984394 — Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease · recruiting
NCT05989399 — Evaluation of Circulating Neutrophils in Antisynthetase Syndrome · recruiting
NCT05523167 — A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Infl · Phase 2, PHASE3 · active not recruiting

Other The First Affiliated Hospital with Nanjing Medical University trials

Trials by the same sponsor.

NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06613490 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University
Last refreshed: 30 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06613490.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing