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NCT06348797
Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC
Phase 1 trial testing α-PD-L1/4-1BB DLL3 CAR-T (BHP01) in Small Cell Lung Cancer Extensive Stage in 28 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Sichuan University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 3 April 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- α-PD-L1/4-1BB DLL3 CAR-T (BHP01) — full drug profile →
Conditions studied
- Small Cell Lung Cancer Extensive Stage — all drugs for Small Cell Lung Cancer Extensive Stage →
Sponsor
Sichuan University
Who can join
Adults 18 to 70, any sex, with Small Cell Lung Cancer Extensive Stage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Challenges and limitations of chimeric antigen receptor T-cell therapies in solid tumors: why are approvals restricted to hematologic malignancies?
Vo MC, Tran VD, Nguyen VT, Ruzimurodov N, et al · · 2025 · cited 13× · PMID 41146230 · DOI 10.1186/s13045-025-01744-9 -
Advancing CAR T-Cell Therapy in Solid Tumors: Current Landscape and Future Directions.
Rafii S, Mukherji D, Komaranchath AS, Khalil C, et al · · 2025 · cited 6× · PMID 40940995 · DOI 10.3390/cancers17172898 -
Recent advances and challenges of cellular immunotherapies in lung cancer treatment.
Yang C, Liu Y, Huang Z, Liu S, et al · · 2025 · cited 5× · PMID 40624569 · DOI 10.1186/s40164-025-00679-8 -
Targeting DLL3: Innovative Strategies for Tumor Treatment.
Wang H, Zheng T, Xu D, Sun C, et al · · 2025 · cited 4× · PMID 40284515 · DOI 10.3390/pharmaceutics17040520 -
Advances in adoptive cell therapies in small cell lung cancer.
Bragasin EI, Cheng J, Ford L, Poei D, et al · · 2025 · cited 3× · PMID 40160238 · DOI 10.37349/etat.2025.1002302 -
CAR-T cells in solid tumors: engineering, biomarkers, translational pathways and the road ahead.
Al Shaer NSH, Masoud I, Tleyjeh A, Al-Attas AA, et al · · 2026 · PMID 41993194 · DOI 10.3389/fimmu.2026.1796675 -
Harnessing CAR-Extracellular Vesicles for Next-Generation Cancer Immunotherapy.
Chelvaretnam S, Mom KT, Palma Henriquez CA, Pham Q, et al · · 2026 · PMID 41828393 · DOI 10.3390/ijms27052163 -
Overcoming Immunotherapy Resistance in Small-Cell Lung Cancer.
Canale M, Suzzi F, Verlicchi A, Citarella F, et al · · 2026 · PMID 41744665 · DOI 10.3390/biology15040356
Verify or expand the search:
- PubMed search for NCT06348797
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Small Cell Lung Cancer Extensive Stage
Currently open trials in the same condition.
- NCT07227597 — A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6 · Phase 1, PHASE2 · recruiting
- NCT07139990 — Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM) · Phase 1 · recruiting
- NCT06739928 — Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC · Phase 2 · recruiting
- NCT06429696 — PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer · Phase 2 · recruiting
- NCT06030258 — IN10018 Combination Therapy in Treatment-naïve ES-SCLC · Phase 1, PHASE2 · recruiting
Other Sichuan University trials
Trials by the same sponsor.
- NCT07501169 — Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lun · Phase 2 · not yet recruiting
- NCT07362732 — Exploratory Study on the Treatment of Recurrent and Refractory Hematological Malignancies With WGb-0302 Injection · EARLY_PHASE1 · not yet recruiting
- NCT07374250 — Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma · Phase 2 · not yet recruiting
- NCT07332663 — Exploratory Study on the Treatment of Relapsed and Refractory B-cell Malignant Tumors With WGb-0301 Injection · EARLY_PHASE1 · not yet recruiting
- NCT07258147 — Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases · Phase 2 · 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 NCT06348797 (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 Sichuan University
- Last refreshed: 16 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/NCT06348797.
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