A clinical trial to learn more about the effects of DJI136 in people with extensive-stage small cell lung cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-27

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2025-523276-23-00

WHO UTN

U1111-1332-6878

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacokinetic, Efficacy, Pharmacodynamic, Safety

All study parts: To characterize the safety and tolerability of DJI136 in patients with small cell lung cancer and identify the recommended dose(s) for future studies
Phase II Group A: To evaluate the preliminary anti-tumor activity of DJI136

Secondary objectives 3

1. Phase I Part A and Phase II: To evaluate the preliminary anti-tumor activity of DJI136
2. Phase II Group A: To further evaluate the preliminary anti-tumor activity of DJI136
3. Phase I Part A and Phase II: To characterize the expansion and persistence of CAR-T cells (cellular kinetics) in peripheral blood and/or tissue by qPCR

Conditions and MedDRA coding

Extensive stage small cell lung cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

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 www.clinicalstudydatarequest.com.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Phase I Part A: 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.
2. Phase II Group A: Patients with ES-SCLC and disease progression after one chemotherapy regimen with 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 DLL-3 targeted therapy is not allowed.
3. Male or female patients must be ≥ 18 years of age.
4. Histologically or cytologically confirmed SCLC.
5. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. 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.
8. Patient must be deemed suitable by the investigator to undergo the lymphodepletion (LD) regimen.
9. Patient must have an apheresis product of non-mobilized cells accepted for manufacturing.

Exclusion criteria 8

1. Prior administration of a genetically modified cellular product, including prior DLL3- targeted CAR-T cell therapy.
2. Unstable or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria.
3. Uncontrolled seizure disorder
4. Clinically significant active infections, including Hepatitis B/C and Human Immunodeficiency Virus (HIV).
5. Has a known additional malignancy that is progressing or requires active treatment, with specific exceptions as defined in the study protocol
6. History of prior solid organ transplant or allogenic hematopoietic cell transplant
7. Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol.
8. Pregnant or nursing women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. All study parts: Incidence and severity of AEs, SAEs, changes in laboratory values, vital signs, and ECGs, Incidence and nature of dose limiting toxicity (DLTs)
2. Phase II Group A: Overall response rate (ORR) as per RECIST v1.1

Secondary endpoints 3

1. Phase I Part A and Phase II: ORR, disease control rate (DCR), duration of response (DoR), and progression free survival (PFS) as per RECIST v1.1
2. Phase II Group A: DCR, DoR, and PFS as per RECIST v1.1
3. Phase I Part A and Phase II: Summary of CAR transgene levels by qPCR in peripheral blood (and other tissue, if available), and cellular kinetic parameters (Cmax, Tmax, AUC, Clast, and Tlast) from peripheral blood profile samples by time point

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 11

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 25 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications