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

Sponsors and collaborators