Small Cell Lung Cancer Extensive Stage Clinical Trial
Official title:
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)
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.
Small cell lung cancer (SCLC) accounts for about 15% of lung cancers, and two-thirds of cases are metastatic at the time of diagnosis. The inhibitory notch ligand delta-like ligand 3 (DLL3) is aberrantly expressed on the surface of up to 85% of SCLC cells and minimally expressed in normal tissues, making it a compelling therapeutic target. This is a phase I, first-in-human, 3+3 dose escalation study to evaluate the safety and feasibility of BHP01 in patents with relapsed/refractory SCLC who progressed after at least 1 platinum based chemotherapy regimen.This is a dose escalation and dose expansion study. 12-21 patients with relapsed/refractory SCLC are planned to be enrolled (Group Pre-A/A/B/C). After the Dose-limiting toxicity (DLT) observation period of the related dose group finished.16 patients are planned to enroll in dose expansion phase who was assign two groups with/without bridge radiotherapy. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02179528 -
Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer(SCLC)
|
Phase 2 | |
Recruiting |
NCT06030258 -
IN10018 Combination Therapy in Treatment-naïve ES-SCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05384015 -
Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer
|
Phase 2 | |
Not yet recruiting |
NCT05745350 -
First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC
|
Phase 2 | |
Completed |
NCT03325816 -
Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05856695 -
A Phase II Study Assessing the Efficacy of Etoposide Free Chemotherapy Plus Durvalumab (MEDI4736) in First Line Extensive Disease Small Cell Lung Cancer (SCLC)
|
Phase 2 | |
Recruiting |
NCT05703971 -
Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06429696 -
PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT00003496 -
Antineoplaston Therapy in Treating Patients With Recurrent or Extensive-Stage Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT03059667 -
Immunotherapy as Second-line in Patient With Small Cell Lung Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03923270 -
Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer
|
Phase 1 | |
Active, not recruiting |
NCT04462276 -
Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease
|
Phase 2 | |
Recruiting |
NCT05680922 -
DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT04967625 -
A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC
|
Phase 2 | |
Recruiting |
NCT04659785 -
A Study of Fluzoparib Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer(FA-ES-SCLC)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04670445 -
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
|
N/A | |
Not yet recruiting |
NCT05066945 -
Application of ctDNA in the Evaluation of Curative Effect and Prognosis of SCLC Patients
|
||
Recruiting |
NCT05945745 -
Molecular Analysis and Treatment Options of SCLC
|
||
Not yet recruiting |
NCT03755115 -
SHR-1210 Combined With Epirubicin in the Treatment of Extensive Disease Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT05027867 -
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
|
Phase 2 |