Study on DJI136, a CAR-T Therapy Targeting DLL3 for Extensive-Stage Small Cell Lung Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT07564401

Provider View

This clinical trial is testing a new CAR-T cell therapy called DJI136 to find the best dose and evaluate its safety and effectiveness in treating extensive-stage small cell lung cancer (ES-SCLC).

Patient Parameters

Program Overview

This study is exploring a new treatment called DJI136, which is a CAR-T cell therapy designed to target DLL3, a protein found in some cancer cells. The trial is in two phases: Phase I will determine the best dose and check the safety of DJI136 in patients whose cancer has worsened after standard chemotherapy. Phase II will further test the treatment's ability to fight cancer in patients who have had similar previous treatments.

Description

This clinical trial is the first to test DJI136, a new CAR-T cell therapy, in humans. The study is being conducted at multiple centers and is open to patients with extensive-stage small cell lung cancer (ES-SCLC). In Phase I, the study will determine the best dose of DJI136 by gradually increasing the dose in patients whose cancer has progressed after receiving standard chemotherapy treatments. This phase will also include an optional exploratory part.

In Phase II, the study will continue with two groups. Group A will include patients whose cancer has worsened after one standard chemotherapy regimen. These patients will receive the dose of DJI136 identified in Phase I to see how well it works against the cancer. There is also an optional exploratory group in this phase.

Eligibility Criteria

Inclusion Criteria

  • Phase I: Patients with ES-SCLC whose cancer has worsened after one or more chemotherapy treatments, including a platinum-based chemotherapy with a PD-L1 inhibitor, unless they were not eligible for these treatments. Previous DLL3-targeted therapy is allowed.
  • Phase II: Patients with ES-SCLC who have received a platinum-based chemotherapy with a PD-L1 inhibitor, unless they were not eligible for these treatments. Previous DLL3-targeted therapy is not allowed.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of small cell lung cancer.
  • Must have at least one tumor that can be measured by scans.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have a tumor tissue sample available from within the last 6 months or be willing to undergo a new biopsy.
  • Must be suitable for a lymphodepletion regimen.
  • Must have a suitable apheresis product for manufacturing.

Exclusion Criteria

  • Previous treatment with genetically modified cell products, including DLL3-targeted CAR-T therapy.
  • Unstable or symptomatic brain metastases or cancer in the brain lining. Stable brain metastases may be eligible if they meet specific criteria.
  • Uncontrolled seizure disorder.
  • Active infections, including Hepatitis B/C and HIV.
  • Another progressing cancer that requires treatment, with some exceptions.
  • History of organ or bone marrow transplants.
  • Significant lung, heart, liver, kidney, or neurological diseases as defined in the study protocol.
  • Pregnant or breastfeeding women.

Other criteria may apply as defined in the study protocol.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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