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NCT05326243
Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma
Phase 1, PHASE2 trial testing CD19-targeted chimeric antigen receptor T-cell in Diffuse Large B Cell Lymphoma in 49 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Pell Bio-Med Technology Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 31 May 2022 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 March 2027 |
| Sites | 5 locations across Taiwan |
Drugs / interventions tested
- CD19-targeted chimeric antigen receptor T-cell — full drug profile →
Conditions studied
- Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →
- Primary Mediastinal Large B Cell Lymphoma — all drugs for Primary Mediastinal Large B Cell Lymphoma →
- Large B-cell Lymphoma — all drugs for Large B-cell Lymphoma →
- Follicular Lymphoma Grade 3A — all drugs for Follicular Lymphoma Grade 3A →
Sponsor
Pell Bio-Med Technology Co., Ltd. — full company profile →
Who can join
14 and older, any sex, with Diffuse Large B Cell Lymphoma or Primary Mediastinal Large B Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multiple center, non-randomized, open-label, phase 1/2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Lymphodepletion - an essential but undervalued part of the chimeric antigen receptor T-cell therapy cycle.
Lickefett B, Chu L, Ortiz-Maldonado V, Warmuth L, et al · · 2023 · cited 108× · PMID 38187393 · DOI 10.3389/fimmu.2023.1303935 -
CAR T-cell therapy for follicular lymphoma and mantle cell lymphoma.
Mohty R, Kharfan-Dabaja MA. · · 2022 · cited 12× · PMID 36544864 · DOI 10.1177/20406207221142133 -
CAR-T Cell Therapy in the Treatment of Pediatric Non-Hodgkin Lymphoma.
Ostojska M, Nowak E, Twardowska J, Lejman M, et al · · 2023 · cited 5× · PMID 38003910 · DOI 10.3390/jpm13111595
Verify or expand the search:
- PubMed search for NCT05326243
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diffuse Large B Cell Lymphoma
Currently open trials in the same condition.
- NCT06687772 — CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant · Phase 2 · recruiting
- NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
- NCT06736613 — A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma · Phase 2 · recruiting
- NCT06552572 — Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy · Phase 2 · active not recruiting
- NCT06550141 — Emapalumab Prevention of CAR-T Cell Associated Toxicities · Phase 2 · 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 NCT05326243 (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 Pell Bio-Med Technology 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/NCT05326243.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing