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NCT06321289
Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL
Phase 1, PHASE2 trial testing Allogeneic CD19-STAR T cell in Non-hodgkin Lymphoma,B Cell in 30 participants. Currently enrolling.
20 March 2026
Quick facts
| Lead sponsor | Chinese PLA General Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 20 March 2024 |
| Primary completion | 20 March 2026 |
| Estimated completion | 20 March 2027 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Allogeneic CD19-STAR T cell — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- Non-hodgkin Lymphoma,B Cell — all drugs for Non-hodgkin Lymphoma,B Cell →
Sponsor
Chinese PLA General Hospital
Who can join
Adults 18 to 75, any sex, with Non-hodgkin Lymphoma,B Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r/r) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock out endogenous receptor α constant (TRAC), human leukocyte antigen (HLA)-A/B, CIITA, and programmed death 1 (PD-1) genes simultaneously in T cells from healthy donors, and integrated the STAR molecule into the TRAC locus using adenovirus associated virus. This strategy can reduce graft-versus-host-disease (GvHD) toxicity and host-versus-graft response, decrease the sensitivity of STAR T cells to immunosuppressive signals, and improve their anti-tumor activity. In this single center, prospective, open-label, single-arm, phase 1/2 study, the safety and efficacy of allogeneic CD19-targeting STAR T cell therapy will be evaluated in patients with r/r B-NHL.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exploring treatment options in cancer: Tumor treatment strategies.
Liu B, Zhou H, Tan L, Siu KTH, et al · · 2024 · cited 536× · PMID 39013849 · DOI 10.1038/s41392-024-01856-7 -
Recent advances in therapeutic gene-editing technologies.
Liu D, Cao D, Han R. · · 2025 · cited 17× · PMID 40119516 · DOI 10.1016/j.ymthe.2025.03.026 -
CRISPR-Cas9 Therapeutics in Early Clinical Development: Delivery and Molecular Diagnostics.
Rutkowska A, Strózik T, Wasiak T, Ciunowicz D, et al · · 2026 · PMID 41972732 · DOI 10.3390/cells15070644 -
The TCR and LCK: foundations for T-cell activation and therapeutic innovation.
Woessner NM, Uleri V, Stepanek O, Minguet S. · · 2025 · PMID 41601693 · DOI 10.3389/fimmu.2025.1737013 -
Therapeutic applications of CRISPR-Cas9 gene editing.
Bharti A, Mudge J. · · 2025 · PMID 41476860 · DOI 10.3389/fgeed.2025.1724291 -
Emerging trends in gene and cell therapy: CRISPR in DNA editing and beyond.
Ji R, Chen Q, Zhang Y. · · 2026 · PMID 41418774 · DOI 10.1016/j.xcrm.2025.102459
Verify or expand the search:
- PubMed search for NCT06321289
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-hodgkin Lymphoma,B Cell
Currently open trials in the same condition.
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- NCT07248163 — Universal CAR-T Cell Therapy for NHL · NA · recruiting
- NCT06716164 — Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research · EARLY_PHASE1 · recruiting
- NCT05909059 — CAR T-cell Therapy in Patients With Renal Dysfunction · Phase 2 · recruiting
- NCT06346912 — CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL · EARLY_PHASE1 · recruiting
Other Chinese PLA General Hospital trials
Trials by the same sponsor.
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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 NCT06321289 (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 Chinese PLA General Hospital
- Last refreshed: 25 March 2024
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/NCT06321289.
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