16 Participants NeededMy employer runs this trial

CAR T Cells for Small Cell Lung Cancer

Recruiting at 6 trial locations
AS
RK
Overseen ByRitesh Kotecha, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DLL3-SAVVYZ-IL18 CAR T cell therapy to determine its safety for people with certain cancers, such as small cell lung cancer and other advanced neuroendocrine tumors. The goal is to find the optimal dose with minimal side effects. Individuals with these cancers, who have not responded to or tolerated other treatments, might be suitable for this trial. Participants must have a specific marker called DLL3 in their tumor to join the study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that DLL3-SAVVYZ-IL18 CAR T cell is likely to be safe for humans?

Research has shown that treatments targeting DLL3, such as DLL3-SAVVYZ-IL18 CAR T cells, could offer promise for small cell lung cancer. Studies suggest these treatments might extend patient survival and may have fewer side effects than some traditional therapies.

In early animal tests, DLL3-targeted CAR T cells proved safe and effective even at low doses. These results are encouraging because they suggest this treatment might be manageable for patients. However, as this trial is just beginning, researchers are still assessing its safety in humans.

While DLL3-targeted treatments are under active investigation, more information is needed to fully understand their safety in people. Prospective trial participants should discuss potential risks and benefits with their doctor.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for small cell lung cancer, which typically involve chemotherapy and radiation, DLL3-SAVVYZ-IL18 CAR T cells offer a cutting-edge approach by harnessing the body's immune system. This therapy is unique because it specifically targets DLL3, a protein found on cancer cells, and it incorporates IL-18 to enhance the immune response, potentially leading to more effective cancer cell destruction. Researchers are excited about this treatment because it represents a personalized and precise attack on cancer cells, which could lead to better outcomes and fewer side effects than traditional options.

What evidence suggests that DLL3-SAVVYZ-IL18 CAR T cell might be an effective treatment for small cell lung cancer?

Research has shown that DLL3-targeted CAR T-cell therapy might help treat small cell lung cancer (SCLC). Early animal studies demonstrated that this therapy significantly shrinks tumors, and in some cases, the cancer completely disappeared after treatment. DLL3, a protein often found in large amounts on SCLC cells, serves as a good target for CAR T cells. Initial results suggest that targeting DLL3 could extend the lives of patients with SCLC. However, these findings come from early research, and further studies are necessary to confirm these benefits in humans. Participants in this trial will receive varying doses of DLL3-SAVVYZ-IL18 CAR T cells to evaluate safety and effectiveness.678910

Who Is on the Research Team?

AS

Adam Schoenfeld, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced DLL3-positive cancers, like small cell lung cancer or neuroendocrine tumors, who have tried standard treatments and their cancer has come back or gotten worse. Participants need to be in good general health, not pregnant or breastfeeding, and willing to use contraception.

Inclusion Criteria

My advanced cancer got worse after first treatment and I meet the study's criteria.
Participant Inclusion Part B: At least 1 measurable lesion per modified RECIST 1.1 within 21 days prior to first LDC dose
I have previously received DLL3-targeted therapy.
See 11 more

Exclusion Criteria

I do not have any uncontrolled or active infections right now.
I do not have a primary brain tumor like glioblastoma.
I do not have unresolved lung inflammation or immune-related brain side effects.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive DLL3-SAVVYZ-IL18 CAR T cell doses to determine the Maximum Tolerated Dose

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DLL3-SAVVYZ-IL18 CAR T cell

Trial Overview

The study is testing a new treatment called DLL3-SAVVYZ-IL18 CAR T cells—engineered immune cells designed to target DLL3-positive cancers. The main goal is to see if this therapy is safe for people with these types of tumors.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Dose Level 2Experimental Treatment1 Intervention
Group II: Dose Level 1Experimental Treatment1 Intervention
Group III: Dose Level -1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Advancement Opportunities and Endeavor of Innovative ...

CAR T-cell regimens) will hopefully further augment the sustained response and resistance of SCLC tumors and ultimately improved the survival outcomes of SCLC ...

DLL3 Targeted Therapies Market Report, Market Size and ...

The Global DLL3 Targeted Therapies Market is valued at USD 472.5 million in 2024 and projected to reach USD 1.34 billion by 2030, growing at a robust 18.9% ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38601455/

DLL3-targeted CAR T-cell therapy in pre-clinical models for ...

DLL3-targeted CAR T-cell therapy in pre-clinical models for small cell lung cancer: safety, efficacy, and challenges.

Insights on Resistance Mechanisms and Sequencing ...

Targets such as DLL3 and B7-H3, which are highly expressed on SCLC cells, are promising candidates for ADCs, bispecific T-cell engagers, and ...

Emerging therapies targeting the delta-like ligand 3 (DLL3) in ...

Several DLL3-targeted therapies are being developed for the treatment of SCLC and other neuroendocrine carcinomas, including antibody-drug ...

CoImmune Obtains License to Target DLL3 with IL-18 ...

The data reported show IL-18 armored CAR-DLL3 T cells could eradicate disease at very low doses, especially when combined with a PD-1 checkpoint ...

DLL3-targeted CAR T-cell therapy in pre-clinical models for ...

DLL3-targeted CAR T-cell therapy in pre-clinical models for small cell lung cancer: safety, efficacy, and challenges. To download the PDF, click the Download ...

Targeting DLL3 in Small Cell Lung Cancer: New Hope ...

The future of DLL3 as a therapeutic target holds great potential, offering hope for improved survival outcomes and reduced side effects for SCLC ...

Emerging therapies targeting the delta-like ligand 3 (DLL3) ...

Several DLL3-targeted therapies are being developed for the treatment of SCLC and other neuroendocrine carcinomas, including antibody-drug ...

Blood Test Predicts Response to Newly Approved SCLC ...

In a cohort of 20 SCLC patients, the blood test showed 85% sensitivity and 100% specificity at predicting clinical benefits of tarlatamab based ...