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A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

• At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Patients must have an archival tumor tissue available, collected within 6 months prior to screening. If an archival tumor sample, collected within 6 months prior to screening, is not available, patients must be willing to undergo a new tumor biopsy at screening; , however this specimen need not be collected prior to scheduling leukapheresis. If a new biopsy is not medically feasible, exceptions may be considered after documented discussion with the Novartis medical monitor.

• Patient must be deemed suitable by the investigator to undergo the lymphodepletion (LD) regimen.

• Patient must have an apheresis product of non-mobilized cells accepted for manufacturing.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2026-06-30
Estimated Completion Date: 2031-03-03
Participants
Target number of participants: 80
Treatments
Experimental: Phase I
Dose escalation with DJI136
Experimental: Phase II
Treatment at the recommended dose(s) of DJI136 as identified in Phase I.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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