Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSichuan University
About this trial
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.
Eligibility criteria
Qualifiers
Patients with recurrent or refractory small cell lung cancer (SCLC) confirmed by histology or cytology who have relapsed or progressed after treatment with one previous platinum-based regimen;
Patients can provide sufficient tumor tissue (fresh or paraffin sections, etc.);
Age 18 ~70 (including boundary), for both men and women;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Disqualifiers
Patients with known primary Central Nervous System (CNS) tumor, or meningeal metastasis, or patients with unstable CNS metastasis (symptomatic, requiring hormonal therapy within 4 weeks before investigational treatment, or no radiographic evidence of stabilization of the lesion for more than 4 weeks);
Received major surgical procedures （except for diagnosis） within 4 weeks before PBMCs collection, or are expected to require major surgical procedures during the study;
Received Chinese herbal medicine or Chinese patent medicine for anti-tumor indications within 7 days before Peripheral Blood Mononuclear Cells (PBMCs) collection;
Patients with a history of idiopathic pulmonary fibrosis, mechanical pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia by chest computer tomography (CT) at screening [a history of radiation pneumonia (fibrosis) in the irradiated field may participate in this study];
Trial design
Treatments tested in this trial
- α-PD-L1/4-1BB DLL3 CAR-T (BHP01)
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Sichuan University
Lead sponsor
Chengdu Brilliant Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov