Actively Recruiting
A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC
Led by Novartis Pharmaceuticals · Updated on 2026-05-27
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DJI136, a DLL3-targeted CAR-T therapy, in adult patients with extensive-stage small cell lung cancer (ES-SCLC). This Phase I/II open-label study aims to find the recommended dose(s) of DJI136 and assess its safety, tolerability, and early signs of effectiveness in patients whose cancer has progressed after chemotherapy. The study includes initial dose escalation and an optional exploratory part in Phase I, followed by Phase II treatment groups to further evaluate the therapy's anti-tumor activity. The treatment involves intravenous infusion of DJI136, a CAR-T cell therapy designed to target DLL3. In Phase I, patients with ES-SCLC who have had disease progression after one or more chemotherapy regimens will receive escalating doses of DJI136. Phase II may include patients receiving the recommended dose identified in Phase I to assess response. The study is non-randomized and open-label, conducted at multiple centers. Participants will undergo various assessments including monitoring of adverse events and dose-limiting toxicities up to about two years. Tumor response will be evaluated using RECIST v1.1 criteria, along with pharmacokinetic measurements of DJI136 levels in blood over time. Patients must provide tumor tissue samples, either archival or from a new biopsy, and will be monitored for safety and treatment effects throughout the study duration, which extends until March 2031.
CONDITIONS
Brief Title
A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with extensive-stage small cell lung cancer (ES-SCLC)
- Disease progression after one or more chemotherapy regimens including platinum-based doublet chemotherapy and PD-L1 inhibitor, unless ineligible or not a candidate for such therapies
- Histologically or cytologically confirmed small cell lung cancer
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Available tumor tissue from within 6 months or willingness to undergo biopsy
- Suitable to undergo lymphodepletion regimen
- Acceptable apheresis product for manufacturing
- Prior DLL3 targeted therapy allowed in Phase I; not allowed in Phase II
You will not qualify if you...
- Prior genetically modified cellular product or DLL3-targeted CAR-T therapy
- Unstable or symptomatic CNS metastases or carcinomatous meningitis; stable brain metastases allowed if criteria met
- Uncontrolled seizure disorder
- Active significant infections including Hepatitis B/C or HIV
- Known additional progressing malignancy requiring treatment (exceptions apply)
- History of solid organ or hematopoietic cell transplant
- Significant pulmonary, cardiac, hepatic, renal, or neurologic disease
- Pregnant or nursing women
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Until disease progression or discontinuation
Participants receive DJI136, a DLL3-targeted CAR-T therapy, administered by intravenous infusion to treat extensive-stage small cell lung cancer after progression on chemotherapy.
Visits as scheduled during treatment for dosing and monitoring
Duration - Up to approximately 2 years
Participants are monitored for safety and treatment effects for up to approximately 2 years after treatment.
Regular follow-up visits for assessments and monitoring
Trial Site Locations
Total: 2 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Novartis Investigative Site
Singapore, Singapore, 168583
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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