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NCT06092047
Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.
EARLY_PHASE1 trial testing UTAA09 cells for infusion in CD19-positive Relapsed or Refractory B-cell Malignancies in 10 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | PersonGen BioTherapeutics (Suzhou) Co., Ltd. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 October 2023 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 April 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- UTAA09 cells for infusion — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- CD19-positive Relapsed or Refractory B-cell Malignancies — all drugs for CD19-positive Relapsed or Refractory B-cell Malignancies →
Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd. — full company profile →
Who can join
Adults 3 to 70, any sex, with CD19-positive Relapsed or Refractory B-cell Malignancies. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Assessment of the safety after UTAA09 injection treatment
Time frame: About 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. -
Evaluation of the efficacy after UTAA09 injection treatment
Time frame: About 3 months
3-month total response rate (ORR) which includes CR, CRi, and PR will be assessed.
Sponsor's own description
This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Diverse Subsets of γδT Cells and Their Specific Functions Across Liver Diseases.
Zhan C, Peng C, Wei H, Wei K, et al · · 2025 · cited 4× · PMID 40141420 · DOI 10.3390/ijms26062778 -
Re-Tooling of γδ T Cells for Cancer Immunotherapy Using Advanced Manufacturing and Genetic Engineering.
Lim BJL, Maher J. · · 2026 · PMID 41892285 · DOI 10.3390/cells15060494 -
Commentary on "Comparative efficacy and safety of PSCA CAR-engineered Vδ1 γδ T cells for immunotherapy of pancreatic cancer".
de Bont DA, Straetemans T, Sebestyén Z, Kuball J. · · 2026 · PMID 41735001 · DOI 10.1136/jitc-2025-014199
Verify or expand the search:
- PubMed search for NCT06092047
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other PersonGen BioTherapeutics (Suzhou) Co., Ltd. trials
Trials by the same sponsor.
- NCT07338604 — Clinical Study of UTAA07 Injection in the Treatment of Hematologic and Lymphatic Systemic Malignancies · EARLY_PHASE1 · recruiting
- NCT07284927 — Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies · Phase 1 · recruiting
- NCT07312630 — Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malign · EARLY_PHASE1 · recruiting
- NCT07188610 — PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma · Phase 2 · recruiting
- NCT06970951 — Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases · EARLY_PHASE1 · 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 NCT06092047 (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 PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Last refreshed: 13 May 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/NCT06092047.
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