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NCT07052383
Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas
Phase 1 trial testing DIT309 cell injection in Osteosarcoma in 15 participants. Not yet recruiting.
10 October 2027
Quick facts
| Lead sponsor | Tcelltech Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 20 August 2025 |
| Primary completion | 10 October 2027 |
| Estimated completion | 10 October 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- DIT309 cell injection — full drug profile →
Conditions studied
- Osteosarcoma — all drugs for Osteosarcoma →
- Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →
Sponsor
Tcelltech Inc. — full company profile →
Who can join
8 and older, any sex, with Osteosarcoma or Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a open-Label, dose-escalation study to evaluate the safety, tolerability and antitumor activity of DIT309 in subjects with advanced bone and soft tissue sarcomas.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
CAR-T cell therapy for pediatric solid tumors: armored CAR-T cells and beyond.
Wells J, Gupta A. · · 2026 · PMID 41770377 · DOI 10.1007/s10555-026-10317-2
Verify or expand the search:
- PubMed search for NCT07052383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteosarcoma
Currently open trials in the same condition.
- NCT07479732 — Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma · Phase 1, PHASE2 · recruiting
- NCT06935409 — Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-li · Phase 3 · active not recruiting
- NCT06521567 — A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer · Phase 1, PHASE2 · active not recruiting
- NCT06709495 — Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adol · Phase 1, PHASE2 · recruiting
- NCT06541262 — Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors · Phase 1, PHASE2 · recruiting
Other Tcelltech Inc. trials
Trials by the same sponsor.
- NCT07485504 — Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies · Phase 1 · not yet recruiting
- NCT07231081 — Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors · Phase 1 · 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 NCT07052383 (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 Tcelltech Inc.
- Last refreshed: 4 July 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/NCT07052383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing