NCT06348797 Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC
| NCT ID | NCT06348797 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan University |
| Condition | Small Cell Lung Cancer Extensive Stage |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-04-03 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy.
Eligibility Criteria
Inclusion Criteria: * Patients with recurrent or refractory small cell lung cancer (SCLC) confirmed by histology or cytology who have relapsed or progressed after treatment with one previous platinum-based regimen; * Patients can provide sufficient tumor tissue (fresh or paraffin sections, etc.); * Age 18 \~70 (including boundary), for both men and women; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Life expectancy ≥3 months; * At least one extracranial measurable lesion (RECIST v1.1) exists；for lesion after radiotherapy， must be confirmed that the lesion has progressed ; * Patients in limited-stage at the initial diagnosis must undergo radical thoracic radiotherapy and the time of tumor progression is not less than 1 months from the end of radiotherapy, or radical thoracic dose radiotherapy cannot be performed for specific reasons; The time elapsed since the completion of radiotherapy for brain metastases shall be no less than 1 months； * The test results of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C and syphilis were negative at screening (If hepatitis B core antibody (HBcAb) is positive, additional HBV DNA testing is required, and subjects whose test result is less than the reference value can be included in the study) ; * Female patients or male reproductive age patients and their partners should agree to effective contraception from sighing Informed Consent Form (ICF) to 6 months after the last BHP01 infusion. Exclusion Criteria: * Patients with known primary Central Nervous System (CNS) tumor, or meningeal metastasis, or patients with unstable CNS metastasis (symptomatic, requiring hormonal therapy within 4 weeks before investigational treatment, or no radiographic evidence of stabilization of the lesion for more than 4 weeks); * Received major surgical procedures （except for diagnosis） within 4 weeks before PBMCs collection, or are expected to require major surgical procedures during the study; * Received Chinese herbal medicine or Chinese patent medicine for anti-tumor indications within 7 days before Peripheral Blood Mononuclear Cells (PBMCs) collection; * Patients with a history of idiopathic pulmonary fibrosis, mechanical pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia by chest computer tomography (CT) at screening \[a history of radiation pneumonia (fibrosis) in the irradiated field may participate in this study\]; * Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures (once a month or more frequently); * Poorly controlled or symptomatic hypercalcemia (ionic calcium\> 1.5 mmol/L, calcium\> 12 mg/dL or corrected calcium\> ULN); * Presence of active or previous autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, etc.; * Severe infection within 4 weeks before the start of PBMCs collection, including but not limited to hospitalization due to infection, bacteremia, severe pneumonia, or any active infection that may affect the patient's safety; * Serious cardiovascular and cerebrovascular diseases (such as heart disease ≥New York Heart Association class II, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months before PBMCs collection; * Previous treatment with DLL 3 target drugs or CAR-T or other gene-modified T cells; * Received any other Investigational drug within 28 days prior to PBMCs collection; * A history of mental illness; * Incapacitated persons or persons with limited capacity; * pregnant or lactating females; Males or females who are unwilling to use adequate contraception; Females of childbearing potential are required to undergo a pregnancy study during the screening period;
Contact & Investigator
You Lu, MD
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT06348797 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Small Cell Lung Cancer Extensive Stage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06348797 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06348797 currently recruiting?
Yes, NCT06348797 is actively recruiting participants. Contact the research team at killercell@163.com for enrollment information.
Where is the NCT06348797 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06348797 clinical trial?
NCT06348797 is sponsored by Sichuan University. The principal investigator is You Lu, MD at West China Hospital. The trial plans to enroll 30 participants.
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