Study of DLL3-CAR-NK Cells in the Treatment of Extensive Stage Small Cell Lung Cancer

NCT05507593 | Unknown Phase 1 DMC

• 1 other identifier: E20220808
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

SCLC, Extensive Stage

Outcome Measures

Primary Outcomes (2)

• The dose-limiting toxicity (DLT)

  1 year

• Maximum tolerated dose (MTD)

  1 year

Study Arms (3)

Group A

EXPERIMENTAL

Patients of group A will be received 1x10\^7 DLL3-CAR-NK cells infusion treatment.

Biological: DLL3-CAR-NK cells

Group B

EXPERIMENTAL

Patients of group B will be received 1x10\^8 DLL3-CAR-NK cells infusion treatment.

Biological: DLL3-CAR-NK cells

Group C

EXPERIMENTAL

Patients of group C will be received 1x10\^9 DLL3-CAR-NK cells infusion treatment.

Biological: DLL3-CAR-NK cells

Interventions

DLL3-CAR-NK cells BIOLOGICAL

Patients of Group A will be received 1x10\^7 DLL3-CAR-NK cells infusion treatment，of group B will be received 1x10\^8 DLL3-CAR-NK cells infusion treatment，and of group C will be received 1x10\^9 DLL3-CAR-NK cells infusion treatment.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• Platelet (PLT) ≥ 100 × 10\^9/L；
• Hemoglobin (HGB) ≥ 100g / L;
• The screening has appropriate organ function and meets the following criteria:
• Aspartate aminotransferase (AST) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);
• Alanine aminotransferase (ALT) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);

You may not qualify if:

• 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 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);
• hepatitis B e antibody (HBE AB) and / or hepatitis B core antibody (HBC AB) are positive, and the copy number of HBV-DNA is greater than the lower measurable limit;
• positive for hepatitis C antibody (HCV AB);
• positive anti Treponema pallidum antibody (TP AB);
• HIV antibody test positive;
• the copy number of EBV-DNA and cmv-dna is greater than the lower measurable limit;
• Those who had or were suffering from other malignant tumors within 2 years before screening;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Study Officials

• Dingzhi Huang, M.D

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Liu, M.D

CONTACT

86-22-23340123; liuliang@tjmuch.com

Xiubao Ren, M.D, Ph.D

CONTACT

86-22-23340123; renxiubao@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 19, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

CN (1)