Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 1/2NCT07564401
A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
A Phase 1/2 study testing DJI136 in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Novartis Pharmaceuticals at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- What is being tested?
- DJI136
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 16 Jun 2026to 3 Mar 2031
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
7 sites in 4 countries
United States3 sites, 3 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Zheng Zhang, +1 713 792 0007, Zzhang11@mdanderson.org
Bingnan Zhang
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Jamie Tarr, +1 859 218 5151, Jamie.Tarr@uky.edu
Zhonglin Hao
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
David Qian, +1 206 288 6938, dqian@fredhutch.org
Diane Tseng
South Korea2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 06351
- Recruiting
Novartis Investigative Site
Seoul, 05505
Australia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Clayton, Victoria, 3168
Singapore1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Singapore, 168583
About this study
Official title: A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC
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.
Read the detailed description
This is a first in human (FIH) Phase I/II, multicenter, open-label study of DJI136 (a CAR-T therapy). The study will start with a Phase I dose escalation with two parts: Part A where patients with ES-SCLC that experience disease progression after one or more chemotherapy regimens according to the standard of care (SOC) will be treated with DJI136. The second part is an optional exploratory component.
The Phase II may follow with two groups. In Group A, ES-SCLC patients who have disease progression after one standard chemotherapy regimen according to the SOC may receive the dose of DJI136 identified in Phase I to assess the preliminary anti-tumor activity of DJI136. The second group is an optional exploratory component.
- Being tested
- DJI136
- 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
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DJI136Drug
DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Dose escalation with DJI136 Receives: Drug: DJI136 |
| Phase II | Experimental | Treatment at the recommended dose(s) of DJI136 as identified in Phase I. Receives: Drug: DJI136 |
What is being measured
The primary outcome is the main question the study is designed to answer.
All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: Up to approximately 2 years
All study parts: Incidence and severity of dose-limiting toxicities (DLTs)
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first 28 days after DJI136 infusion and meets the criteria defined in the protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Measured: 28 days
Phase II Group A: Overall response rate (ORR) as per RECIST v1.1
Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
ORR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of Complete response (CR) or Partial response (PR).
Measured: Up to approximately 2 years
Secondary outcomes (9)
Phase I Part A and Phase II exploratory group: Overall response rate (ORR) as per RECIST v1.1
Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
ORR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of Complete response (CR) or Partial response (PR).
Measured: Up to approximately 2 years
Phase I Part A and Phase II: Disease control rate (DCR) as per RECIST v1.1
Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
DCR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of CR, PR, or Stable disease (SD).
Measured: Up to approximately 2 years
Phase I Part A and Phase II: Duration of response (DOR) as per RECIST v1.1
Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
DOR is defined as the time from the date of the first documented response (CR or PR) to the date of the first documented progression according to RECIST v1.1 or death due to underlying cancer.
Measured: Up to approximately 2 years
Phase I Part A and Phase II: Progression free survival (PFS) as per RECIST v1.1
Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
PFS is defined as the time from the date of DJI136 infusion to the date of the first documented progression according to RECIST v1.1, or death due to any cause.
Measured: Up to approximately 2 years
Phase I Part A and Phase II: Maximum observed concentration (Cmax) in peripheral blood
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 chimeric antigen receptor (CAR) transgene concentrations in peripheral blood.
Measured: From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Time to reach maximum observed concentration (Tmax) in peripheral blood
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
Measured: From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Area under the peripheral blood concentration-time curve (AUC)
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
Measured: From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Last observed quantifiable concentration (Clast) in peripheral blood
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
Measured: From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Time of last observed quantifiable concentration (Tlast) in peripheral blood
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
Measured: From pre-dose up to Day 720 (Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start16 Jun 2026
- Primary completion3 Mar 2031 (estimated)
- Study completion3 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small Cell Lung Cancer (ES-SCLC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564401
- Sponsor's protocol ID
- CDJI136A12101
- Other IDs
- 2025-523276-23, 2025
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.