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Trial Title:
SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma
NCT ID:
NCT06384482
Condition:
Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Recurrence
Conditions: Keywords:
DLL3 CAR-T small cell lung cancer Lung large cell neuroendocrine carcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SNC115 injection
Description:
SNC115 Injection is DLL3 CART.
Arm group label:
Single Arm
Summary:
This study is a FIH dose escalation clinical study, with single arm, open label and
design, in order to observe the preliminary safety and Pharmacokinetic of SNC115
Injection in participants with Recurrent/refractory small cell lung cancer and Lung large
cell neuroendocrine carcinoma.
Detailed description:
The study will enroll at most 35 participants diagnosed with Recurrent/refractory small
cell lung cancer or Lung large cell neuroendocrine carcinoma.
There will be about 5 preset dose groups in this clinical trial, Participants will be
enrolled from low dose group to high dose group. Dose escalation will be decided by the
SRC (Safety Review Committee). There will be expanded cases in the aim dose group.
The protocol will be performed into Screening period (-30+ days), Mononuclear cells
acquisition, Lymphodepletion (-5~-3 days), SNC115 Injection infusion and DLT observation
period (day 0~28days), and follow-up period (1-5 years). According to the administration
strategy, we will start from single administration.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old, regardless of gender;
2. Histological or cytological diagnosis of SCLC or pulmonary LCNEC (WHO 2021)
3. Relapse or refractory after receiving at least first-line standard therapy, or
inability to tolerate first-line standard therapy
4. Eastern Cooperative Oncology Group score 0-1;
5. At least one measurable tumor lesion (other than brain metastases) according to
solid tumor response criteria 1.1 (RECIST1.1)
6. Measurable lesions with an expected survival of more than 3 months;
7. Expected survival ≥12 weeks.
8. Adequate organ and bone marrow function.
9. The subjects agreed to use reliable contraceptive methods for contraception within 1
year from the signing of informed consent to reinfusion.
10. Voluntarily participate in clinical trials and sign informed consent.
Exclusion Criteria:
1. Known allergic reaction, hypersensitivity, intolerance or contraindication to SNC115
Injection or any component of drugs that may be used in the study (including
fludarabine, cyclophosphamide and Tocilizumab).
2. Have received any previous CAR-T therapy or other gene-modified cell therapy.
3. Have received any previous treatment targeting DLL3.
4. Uncontrolled pleural effusion, pericardial effusion, and ascites (uncontrolled
refers to repeated drainage).
5. Untreated (including new lesions or progression after previous treatment) or
symptomatic brain metastases.
6. Have medical history of study excluded thrombosis, Systemic autoimmune disease,
cardiopathy, cancer, infection disease and so on.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Zhong, MD/PhD
Phone:
021-22200000
Email:
ctqxkyy@163.com; eddiedong8@hotmail.com
Start date:
April 30, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Shanghai Simnova Biotechnology Co.,Ltd.
Agency class:
Industry
Collaborator:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Simnova Biotechnology Co.,Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06384482
