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

ConditionSmall Cell Lung Cancer Extensive Stage
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: α-PD-L1/4-1BB DLL3 CAR-T (BHP01) TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Safety

Time frame
day1-day28

Secondary outcomes

1

Objective Response Rate (ORR)

The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1. In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation.

Time frame
up to 1 year after the enrollment
2

Progression-free survival (PFS)

The time from CAR-T administration to disease progression or death.

Time frame
up to 1 year after the enrollment
3

Disease control rate (DCR)

The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%).

Time frame
up to 1 year after the enrollment
4

Duration of response (DOR)

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause

Time frame
up to 1 year after the enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Chengdu Brilliant Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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