A Multicenter Phase I Trial on the Safety and Preliminary Efficacy of DLL3-CAR-NK Cells in the Treatment of Relapsed / Refractory Extensive Stage Small Cell Lung Cancer

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country18 target enrollmentSeptember 1, 2022

ConditionsSCLC, Extensive Stage

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: SCLC, Extensive Stage
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 18
Locations: 1
Primary Endpoint: Maximum tolerated dose (MTD)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, open-label, phase I clinical trial aimed to evaluate the safety and efficacy of DLL3-CAR-NK cells treatment for relapsed and refractory extensive small cell lung cancer (ES-SCLC).

Detailed Description

This study is a multicenter, single arm, open-label, non randomized, single dose, dose escalation, phase I clinical trial on relapsed and refractory ES-SCLC. The phase I clinical trial will be conducted according to the principle of "3 + 3". Three dose groups will be set up, namely group A: 1.0 × 10\^7, group B: 1.0 × 10\^8, and group C: 1.0 × 10\^9 DLL3-CAR-NK cells. 9-18 subjects will be enrolled in the groups and given a single infusion of DLL3-CAR-NK cells injection in order to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), evaluate the safety and efficacy of the cell infusion. It well be recommend dose for phase II clinical study (recommended phase II dose, RP2D).

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

July 1, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Only patient who meet all the following conditions can be selected for this trial:
•Patients voluntarily sign informed consent;
•The age was 18-75 years old, and the gender was not limited;
•Patients who meet the following diagnosis and treatment : 1) small cell lung cancer diagnosed by tissue / cytology; 2) extensive small cell lung cancer diagnosed by imaging according to VALG and AJCC-8; 3) disease progression after receiving at least one line treatment, and disease progression within 6 months after the last line treatment;
•The expected survival time was more than 3 months;
•There are measurable target lesions on imaging during screening: the maximum diameter is greater than 1.0 cm;
•The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 for physical fitness;
•Sufficient bone marrow reserve at screening, defined as:
•Neutrophil absolute value (ANC) \> 1.5 × 10\^9/L；
•Lymphocyte absolute value (ALC) ≥ 0.3 × 10\^9/L；

Exclusion Criteria

•Patient who meet any of the following conditions well excluded in this trial:
•At the time of screening, patients with symptomatic central nervous system (CNS) metastases (asymptomatic CNS metastases, or asymptomatic after local treatment and stable condition for 4 weeks can be enrolled);
•Those with a history of central nervous system before screening, such as epilepsy, cerebral ischemia / hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome, mental disease or any autoimmune disease involving the central nervous system;
•Those who had received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening and were assessed by the investigator as unsuitable for inclusion;
•Those who stopped systemic hormone therapy for less than 72 hours before cell transfusion; But it is allowed to use a physiological substitute amount of hormone (such as prednisone \< 10mg / D or equivalent);
•Those who have used any adoptive cell therapy before screening;
•Those who have received organ / tissue transplantation before screening;
•Active systemic autoimmune disease is known before screening and is under treatment;
•Those who meet any of the following conditions during screening:
•positive for hepatitis B surface antigen (HBsAg) and / or hepatitis B e antigen (HBeAg);