2025-523276-23-00招募中2 期
A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- 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)
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •Male or female patients must be ≥ 18 years of age.
- •Histologically or cytologically confirmed 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
- •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.
排除标准
- •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.
研究组 & 干预措施
DJI136
Test
干预措施: DJI136 (Drug)
CYCLOPHOSPHAMIDE
Auxiliary
干预措施: CYCLOPHOSPHAMIDE (Drug)
FLUDARABINE PHOSPHATE
Auxiliary
干预措施: FLUDARABINE PHOSPHATE (Drug)
BENDAMUSTINE HYDROCHLORIDE
Auxiliary
干预措施: BENDAMUSTINE HYDROCHLORIDE (Drug)
TOCILIZUMAB
Auxiliary
干预措施: TOCILIZUMAB (Drug)
结局指标
主要结局
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)
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)
Phase II Group A: Overall response rate (ORR) as per RECIST v1.1
Phase II Group A: Overall response rate (ORR) as per RECIST v1.1
次要结局
- 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
- Phase II Group A: DCR, DoR, and PFS as per RECIST v1.1
- 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
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (7)
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