DJI136 CAR-T therapy for extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human Phase I/II, open-label, multicenter study to determine a safe dose and to evaluate preliminary activity of DJI136 in adults with extensive-stage SCLC. The trial starts with a Phase I dose-escalation to establish recommended dose, followed by an optional exploratory component. In Phase II, two groups will assess anti-tumor activity of the same dose in patients whose disease progressed after standard platinum-based chemotherapy with PD-L1 inhibitor. DJI136 is the investigational CAR-T therapy being studied across multiple US sites.

Why it matters

Who can join: the full rules

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 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.

Exclusion Criteria:

* 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).
* Has a known additional malignancy that is progressing or requires active treatment, with specific exceptions as defined in the study protocol.
* History of prior solid organ transplant or allogenic hematopoietic cell transplant
* Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol.
* Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Fred Hutchinson Cancer Center
  Seattle, Washington, United States Recruiting
• Novartis Investigative Site
  Clayton, Victoria, Australia Recruiting
• Novartis Investigative Site
  Singapore, Singapore Recruiting
• Novartis Investigative Site
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.