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NCT06348797

Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC

Recruiting now Phase 1 Last updated 16 May 2025
What this trial tests

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.

Timeline
3 April 2025
Primary endpoint
30 June 2026
31 December 2026

Quick facts

Lead sponsorSichuan University
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment28
Start date3 April 2025
Primary completion30 June 2026
Estimated completion31 December 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other recruiting trials for Small Cell Lung Cancer Extensive Stage

Currently open trials in the same condition.

Other Sichuan University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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