80 Participants NeededMy employer runs this trial

DJI136 CAR-T Therapy for Small Cell Lung Cancer

Recruiting at 5 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Novartis Pharmaceuticals
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 aims to determine the optimal dose and assess the safety and effectiveness of a new treatment called DJI136 CAR-T therapy for individuals with extensive-stage small cell lung cancer (ES-SCLC). The study consists of two parts: the first part identifies the appropriate dose, while the second part evaluates the treatment's effectiveness at that dose. It targets those who have previously undergone chemotherapy with a platinum-based medicine and a PD-L1 inhibitor but require additional options. Participants must have a confirmed diagnosis of small cell lung cancer and at least one measurable tumor. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering a chance to be among the first to benefit from this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that DJI136 is likely to be safe for humans?

Early lab studies have shown that DJI136, a type of CAR-T therapy, is safe and effective in small cell lung cancer models. This treatment targets a protein called DLL3, found on cancer cells. Although researchers are still testing DJI136 in people, similar treatments have shown side effects like fever, tiredness, and low blood cell counts, with serious side effects being less common. These studies aim to find the safest dose and identify any side effects. Ongoing research will help determine how well patients can tolerate DJI136.12345

Why do researchers think this study treatment might be promising for small cell lung cancer?

Researchers are excited about DJI136 CAR-T Therapy for small cell lung cancer because it represents a new approach in cancer treatment. Unlike standard chemotherapy and radiation, which attack cancer cells broadly, DJI136 uses a patient's own genetically modified T-cells to specifically target and destroy cancer cells. This personalized treatment could potentially lead to fewer side effects and improved efficacy. By harnessing the body's immune system, DJI136 offers a promising alternative to traditional therapies, which often come with significant side effects and varied effectiveness.

What evidence suggests that DJI136 might be an effective treatment for small cell lung cancer?

Research has shown that DJI136, a type of CAR-T cell therapy targeting DLL3, may help treat extensive-stage small cell lung cancer (ES-SCLC). In studies with patients whose cancer returned or didn't respond to other treatments, DJI136 shrank or eliminated cancer in about 29 out of 100 people. Additionally, nearly 79 out of 100 patients experienced control over their cancer's growth. This trial will evaluate DJI136 in two phases: Phase I will focus on dose escalation, and Phase II will treat participants at the recommended dose(s) identified in Phase I. These early findings suggest that DJI136 could effectively manage ES-SCLC, but more research is needed to fully understand its potential.12346

Are You a Good Fit for This Trial?

This trial is for adults (18+) with extensive-stage small cell lung cancer that has come back or worsened after standard treatments, including chemo and immunotherapy. Participants need to have at least one tumor that can be measured, good physical health, and available recent tumor tissue.

Inclusion Criteria

Patient must be deemed suitable by investigator to undergo lymphodepletion regimen
I have tumor tissue from the last 6 months or am willing to have a new biopsy.
At least one measurable lesion as defined by RECIST 1.1
See 6 more

Exclusion Criteria

I have seizures that are not controlled by medication.
I have had an organ or stem cell transplant from a donor.
I have received genetically modified cell therapy before.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Dose escalation with DJI136 for patients with ES-SCLC experiencing disease progression after chemotherapy

28 days
Multiple visits for dose escalation and monitoring

Phase II Treatment

Treatment at the recommended dose(s) of DJI136 as identified in Phase I to assess preliminary anti-tumor activity

Up to 2 years
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • DJI136

Trial Overview

The study is testing DJI136, a new CAR-T cell therapy targeting DLL3 in people with advanced small cell lung cancer. It aims to find the best dose and check safety and early effectiveness. All participants receive the treatment; there is no placebo group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Phase IIExperimental Treatment1 Intervention
Group II: Phase IExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy

This is a Phase I/II, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) tolerability and ...

DJI136 / Legend Biotech, Novartis

CAR T-Cell Therapy • Small Cell Lung Cancer • Solid Tumor. ORR: 28.6%; DCR: 78.6%; CAR-T cell therapy, in patients with relapsed or refractory small cell lung ...

CAR-T therapy in non-small cell lung cancer - PMC - NIH

T-cell (CAR-T) therapy has shown impressive and long-lasting results in blood cancers, but its success in solid tumors such as lung cancer ...

A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy

This is a Phase I/II, open-label, center study in patients with extensive-stage small cell lung cancer safety, tolerability and preliminary ...

New CAR T-Cell Strategy Highly Effective Against Small ...

CAR T cells targeting DLL3 are highly effective in small cell lung cancer models,” median overall survival stands at just 13 months. fallen ...

CAR T-Cell Therapy Holds Potential in SCLC, but ...

CAR T-cell therapy shows promise for SCLC, but significant barriers, such as tumor heterogeneity and immunosuppression, must be addressed.