CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 28 target
Drug / intervention
α-PD-L1/4-1BB DLL3 CAR-T (BHP01)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06348797
NCT06348797Phase 1RecruitingOn TrackUpdated 13mo ago
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Phase I Clinical Study on Safety and Feasibility of DLL3 Targeted α-PD-L1/4-1BB Modifying Chimeric Antigen Receptor T-cells in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

Sichuan University·interventional·Posted Apr 5, 2024·Updated May 16, 2025

In Brief

A Phase 1 clinical trial evaluating α-PD-L1/4-1BB DLL3 CAR-T (BHP01) for Small Cell Lung Cancer Extensive Stage. Currently recruiting, targeting 28 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer Extensive Stage
CountriesChina
CollaboratorsChengdu Brilliant Pharmaceutical Co., Ltd.

Timeline

Phase 1Recruiting
202520262027
First PostedApr 5, 2024
Enrollment StartApr 3, 2025
Primary CompletionJun 30, 2026
Study CompletionDec 31, 2026
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 2.2 years ago

Interventions

α-PD-L1/4-1BB DLL3 CAR-T (BHP01)drug

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses; Bridge radiotherapy with 15 Gray (Gy)/5 fractions; α-PD-L1/4-1BB DLL3 CAR-T (BHP01): the first dose was 5x10\^5/kg.