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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

About this trial

This is a Phase I/II, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.

Eligibility criteria

Qualifiers

Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, according to the investigator's judgement. Prior DLL3 (Delta-like ligand 3) targeted therapy is allowed.

Phase II: Patients with ES-SCLC who have received a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor according to local standard of care, unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, as determined by the investigator's judgment. Prior DLL-3 targeted therapy is not allowed.

Male or female patients must be ≥ 18 years of age.

Histologically or cytologically confirmed small cell lung cancer (SCLC).

Disqualifiers

Prior administration of a genetically modified cellular product, including prior DLL3-targeted CAR-T cell therapy.

Unstable or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria.

Uncontrolled seizure disorder.

Clinically significant active infections, including Hepatitis B/C and Human Immunodeficiency Virus (HIV).

Trial design

Treatments tested in this trial

  • DJI136

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

4
Singapore
Novartis Investigative Site168583, Singapore Singapore
United States
University of Kentucky40536, LexingtonKentucky, United States
MD Anderson Cancer Center77030, HoustonTexas, United States
Fred Hutchinson Cancer Center98109, SeattleWashington, United States

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor