A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Sequential
Treatments tested in this trial
DJI136
DrugDLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Phase IExperimental treatment 1 intervention
Group B: Phase IIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to approximately 2 years2
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.
Time frame
28 days3
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).
Time frame
Up to approximately 2 yearsSecondary outcomes
1
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).
Time frame
Up to approximately 2 years2
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).
Time frame
Up to approximately 2 years3
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.
Time frame
Up to approximately 2 years4
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.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov