A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests DJI136, a CAR-T treatment that uses modified immune cells to target a protein called DLL3. It is for adults with small cell lung cancer that has spread widely. The study will find recommended doses, check safety and side effects, and look for early signs that the treatment works.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be at least 18 and have small cell lung cancer confirmed by a tissue or cell test.
- For Phase I, your cancer must have worsened after at least one chemotherapy treatment, including two-drug platinum chemotherapy with a PD-L1 blocker, an immune treatment. Exceptions may apply if the study doctor says standard treatments were not suitable. Past DLL3-targeted treatment is allowed.
- For Phase II, you must have had two-drug platinum chemotherapy with a PD-L1 blocker. Exceptions may apply if the study doctor says standard treatments were not suitable. Past DLL3-targeted treatment is not allowed.
- You must have at least one tumor that can be measured using the study's rules.
- You must be fully active or able to do light work despite limits on hard physical activity.
- You must have a stored tumor sample taken within 6 months before screening, or be willing to have a new biopsy to remove a small tissue sample. An exception may be considered if a new biopsy is not medically possible.
- The study doctor must decide you can receive treatment to lower your immune cell count before CAR-T therapy.
- Your collected blood cells must be accepted for making the study treatment.
Who can't join
- You have had a treatment using genetically modified cells, including DLL3-targeted CAR-T therapy.
- You have cancer spread to the brain or spinal cord that is unstable or causes symptoms, or cancer in their lining. Stable brain tumors may be allowed under specific study rules.
- You have seizures that are not controlled.
- You have a serious active infection, including hepatitis B, hepatitis C, or HIV.
- You have another cancer that is growing or needs treatment, unless a study exception applies.
- You have had a solid organ transplant or a blood-forming cell transplant from a donor.
- You have another serious lung, heart, liver, kidney, or nervous system disease, as defined by the study.
- You are pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (3)
KY
- University of Kentucky · Lexington, KY 40536Jamie Tarr · Study contact · 859-218-5151 · Jamie.Tarr@uky.eduZhonglin Hao · Principal investigatorMore trials in Lexington
TX
- MD Anderson Cancer Center · Houston, TX 77030Zheng Zhang · Study contact · 713-792-0007 · Zzhang11@mdanderson.orgBingnan Zhang · Principal investigatorMore trials in Houston
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109David Qian · Study contact · 206-288-6938 · dqian@fredhutch.orgDiane Tseng · Principal investigatorMore trials in Seattle