A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy (NCT07564401) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
80 participantsStarted 2026-05-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 …
What they're measuring
1
All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to approximately 2 years
2
All study parts: Incidence and severity of dose-limiting toxicities (DLTs)
Timeframe: 28 days
3
Phase II Group A: Overall response rate (ORR) as per RECIST v1.1