Recruiting
Phase 1
Phase 2

DJI136

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07564401

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DJI136

Study Details

Brief 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.

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Study ID

NCT07564401

Start date

Jun 16, 2026

Status verified date

Jun, 2026

Completion date

Mar 3, 2031

Anticipated

Primary completion date

Mar 3, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I

Dose escalation with DJI136

experimental: Phase II

Treatment at the recommended dose(s) of DJI136 as identified in Phase I.

Interventions

DJI136

DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.

Primary outcome measure

  • All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to approximately 2 years ]
  • All study parts: Incidence and severity of dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
  • Phase II Group A: Overall response rate (ORR) as per RECIST v1.1 [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Jamie Tarr

859-218-5151Jamie.Tarr@uky.edu

Principal Investigator:

Zhonglin Hao

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Zheng Zhang

713-792-0007Zzhang11@mdanderson.org

Principal Investigator:

Bingnan Zhang

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

David Qian

206-288-6938dqian@fredhutch.org

Principal Investigator:

Diane Tseng

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Small cell lung cancer
  • SCLC
  • Extensive-stage small cell lung cancer
  • ES-SCLC
  • Chimeric antigen receptor (CAR)-T cell therapy
  • Delta-like ligand 3
  • DLL3
  • DJI136

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-06-23.