Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine CarcinomaPhase 1NCT06384482
SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma
A Phase 1 study testing SNC115 injection in people with Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma, run by Shanghai Simnova Biotechnology Co.,Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma
- What is being tested?
- SNC115 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 30 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, regardless of gender;
- Histological or cytological diagnosis of SCLC or pulmonary LCNEC (WHO 2021)
- Relapse or refractory after receiving at least first-line standard therapy, or inability to tolerate first-line standard therapy
- Eastern Cooperative Oncology Group score 0-1;
- At least one measurable tumor lesion (other than brain metastases) according to solid tumor response criteria 1.1 (RECIST1.1)
- Measurable lesions with an expected survival of more than 3 months;
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- Expected survival ≥12 weeks.
- Adequate organ and bone marrow function.
- The subjects agreed to use reliable contraceptive methods for contraception within 1 year from the signing of informed consent to reinfusion.
- Voluntarily participate in clinical trials and sign informed consent.
Who cannot join
- 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).
- Have received any previous CAR-T therapy or other gene-modified cell therapy.
- Have received any previous treatment targeting DLL3.
- Uncontrolled pleural effusion, pericardial effusion, and ascites (uncontrolled refers to repeated drainage).
- Untreated (including new lesions or progression after previous treatment) or symptomatic brain metastases.
- Have medical history of study excluded thrombosis, Systemic autoimmune disease, cardiopathy, cancer, infection disease and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong, MD/PhD, 021-22200000, ctqxkyy@163.com; eddiedong8@hotmail.com
About this study
Official title: To Evaluate the Safety and Pharmacokinetic of SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Crcinoma: an Open-label, Single-arm, Dose Escalation Exploratory Study
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.
Read the 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.
- Being tested
- SNC115 injection
- Keywords
- DLL3 CAR-T small cell lung cancer Lung large cell neuroendocrine carcinoma
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNC115 injectionDrug
SNC115 Injection is DLL3 CART.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: SNC115 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of SNC115 Injection
Safety of SNC115 Injection will be assessed by incidence and severity of AEs and SAEs.
Measured: Day 1 through Month 18
Safety of SNC115 Injection
Safety of SNC115 Injection will be assessed by occurrenced rate of DLT.
Measured: Day 1 through Month 18
Secondary outcomes (6)
-Efficacy of SNC115 Injection
Efficacy of SNC115 will be characterized by ORR,according to investigator assessment referring RECISIT 1.1.
Measured: Day 1 through Month 18
-Efficacy of SNC115 Injection
Efficacy of SNC115 will be characterized by DoR,according to investigator assessment referring RECISIT 1.1.
Measured: Day 1 through Month 18
-Efficacy of SNC115 Injection
Efficacy of SNC115 will be characterized by DCR,according to investigator assessment referring RECISIT 1.1.
Measured: Day 1 through Month 18
-Efficacy of SNC115 Injection
Efficacy of SNC115 will be characterized by PFS,according to investigator assessment referring RECISIT 1.1.
Measured: Day 1 through Month 18
-Efficacy of SNC115 Injection
Efficacy of SNC115 will be characterized by OS,according to investigator assessment referring RECISIT 1.1.
Measured: Day 1 through Month 18
-Efficacy of SNC115 Injection
Efficacy of SNC115 will be characterized by TTR,according to investigator assessment referring RECISIT 1.1.
Measured: Day 1 through Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384482
- Sponsor's protocol ID
- SNC115-DLL3 CART-101
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Pharmacokinetic of SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Crcinoma: an Open-label, Single-arm, Dose Escalation Exploratory Study
- ClinicalTrials.gov ID
- NCT06384482
- Acronym / sponsor ID
- SNC115-DLL3 CART-101
- Keywords
- DLL3 CAR-T small cell lung cancer Lung large cell neuroendocrine carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: SNC115 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old, regardless of gender;
- Histological or cytological diagnosis of SCLC or pulmonary LCNEC (WHO 2021)
- Relapse or refractory after receiving at least first-line standard therapy, or inability to tolerate first-line standard therapy
- Eastern Cooperative Oncology Group score 0-1;
- At least one measurable tumor lesion (other than brain metastases) according to solid tumor response criteria 1.1 (RECIST1.1)
Key exclusion criteria (6 listed)
- 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).
- Have received any previous CAR-T therapy or other gene-modified cell therapy.
- Have received any previous treatment targeting DLL3.
- Uncontrolled pleural effusion, pericardial effusion, and ascites (uncontrolled refers to repeated drainage).
- Untreated (including new lesions or progression after previous treatment) or symptomatic brain metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNC115 injectionSNC115 Injection is DLL3 CART. | Drug | Single Arm |
Primary outcome
Safety of SNC115 Injection
Time frame: Day 1 through Month 18
Safety of SNC115 Injection will be assessed by incidence and severity of AEs and SAEs.
Safety of SNC115 Injection
Time frame: Day 1 through Month 18
Safety of SNC115 Injection will be assessed by occurrenced rate of DLT.
6 secondary outcomes
-Efficacy of SNC115 Injection
Time frame: Day 1 through Month 18
-Efficacy of SNC115 Injection
Time frame: Day 1 through Month 18
-Efficacy of SNC115 Injection
Time frame: Day 1 through Month 18
-Efficacy of SNC115 Injection
Time frame: Day 1 through Month 18
-Efficacy of SNC115 Injection
Time frame: Day 1 through Month 18
-Efficacy of SNC115 Injection
Time frame: Day 1 through Month 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNC115 injection in people with Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma, run by Shanghai Simnova Biotechnology Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of SNC115 Injection (time frame: Day 1 through Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.