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NCT06083883
Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1
Phase 1 trial testing Fludarabine phosphate in Synovial Sarcoma in 44 participants. Currently enrolling.
30 November 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 27 March 2024 |
| Primary completion | 30 November 2026 |
| Estimated completion | 30 November 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fludarabine phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
- NY-ESO-1 TCR/IL-15 NK — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- Synovial Sarcoma — all drugs for Synovial Sarcoma →
- Myxoid/Round Cell Liposarcoma — all drugs for Myxoid/Round Cell Liposarcoma →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 16 to 80, any sex, with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comprehensive snapshots of natural killer cells functions, signaling, molecular mechanisms and clinical utilization.
Chen S, Zhu H, Jounaidi Y. · · 2024 · cited 106× · PMID 39511139 · DOI 10.1038/s41392-024-02005-w -
Emerging roles of type 1 innate lymphoid cells in tumour pathogenesis and cancer immunotherapy.
Verner JM, Arbuthnott HF, Ramachandran R, Bharadwaj M, et al · · 2024 · cited 9× · PMID 38745765 · DOI 10.37349/etat.2024.00219 -
Advances and challenges in chimeric antigen receptor-natural killer cell immunotherapy for cancer.
Rafei H, Rezvani K. · · 2025 · cited 8× · PMID 39622255 · DOI 10.1111/bjh.19939 -
Review of Adoptive Cellular Therapies for the Treatment of Sarcoma.
Fradin JJ, Charlson JA. · · 2025 · cited 3× · PMID 40282478 · DOI 10.3390/cancers17081302 -
Unleashing NK cells for cancer immunotherapy in lung cancer: biologic challenges and clinical advances.
McLaughlin Q, Sojka DK, Kennedy K, Piersma SJ, et al · · 2025 · cited 2× · PMID 40849493 · DOI 10.1186/s13046-025-03503-7 -
CIMT 2024: Report on the 21st Annual Meeting of the Association for Cancer Immunotherapy.
Ahrberg Y, Dallmann J, Freitag J, Hassan A, et al · · 2024 · cited 1× · PMID 39043196 · DOI 10.1080/21645515.2024.2381925 -
Sarcomas in Adolescents and Young Adults.
Greenmyer JR, Allen-Rhoades W. · · 2026 · PMID 42159886 · DOI 10.1007/s11912-026-01781-8 -
T cell immunotherapy for solid tumors: limitations, progress, and future prospects.
Wang Y, Zhang B, Wang Y, Tan Y, et al · · 2026 · PMID 41694348 · DOI 10.3389/fimmu.2026.1755751
Verify or expand the search:
- PubMed search for NCT06083883
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Synovial Sarcoma
Currently open trials in the same condition.
- NCT05642455 — SPEARHEAD-3 Pediatric Study · Phase 1, PHASE2 · recruiting
- NCT05492682 — START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer · Phase 1 · active not recruiting
- NCT04995003 — HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma · Phase 1 · recruiting
- NCT04420975 — Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma · Phase 1 · active not recruiting
- NCT04044768 — Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma · Phase 2 · active not recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06083883 (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 M.D. Anderson Cancer Center
- Last refreshed: 16 April 2026
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/NCT06083883.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing