Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
DART-NK-SCLC
A Phase 1/2 Adaptive Dose-Escalation and Expansion Study of Dual-Targeting Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Directed Against DLL3, CD56 (NCAM1), and/or GD2 in Adults With Relapsed/Refractory Small Cell Lung Cancer
1 other identifier
interventional
60
1 country
1
Brief Summary
This study is an open-label, multi-center, adaptive Phase 1/2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3/CD56, DLL3/GD2, and CD56/GD2) will be assessed during dose escalation; a pre-specified interim assessment will select the most suitable construct to proceed into an expansion cohort at the recommended Phase 2 dose (RP2D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2026
CompletedFirst Submitted
Initial submission to the registry
February 14, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 17, 2028
March 18, 2026
March 1, 2026
1 year
February 14, 2026
March 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of dose-limiting toxicities (DLTs)
28 Days
Maximum tolerated dose (MTD)
12 months
Secondary Outcomes (3)
Objective response rate (ORR)
12 months
Progression-free survival (PFS)
24 months
Overall survival (OS)
24 months
Study Arms (3)
DLL3/CD56 Dual-Target CAR-NK (EB-DART-NK01)
EXPERIMENTALAllogeneic dual-target CAR-NK cells targeting DLL3 and CD56 (NCAM1) following lymphodepleting chemotherapy.
DLL3/GD2 Dual-Target CAR-NK (EB-DART-NK02)
EXPERIMENTALAllogeneic dual-target CAR-NK cells targeting DLL3 and GD2 following lymphodepleting chemotherapy.
CD56/GD2 Dual-Target CAR-NK (EB-DART-NK03)
EXPERIMENTALAllogeneic dual-target CAR-NK cells targeting CD56 (NCAM1) and GD2 following lymphodepleting chemotherapy
Interventions
EB-DART-NK01 (DLL3/CD56 CAR-NK cells)
(fludarabine + cyclophosphamide)
Eligibility Criteria
You may qualify if:
- Age 18 to 75 years at the time of consent.
- Histologically or cytologically confirmed small cell lung cancer (SCLC) that is metastatic, extensive-stage, or unresectable, and relapsed or refractory after at least 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated).
- At least one measurable lesion per RECIST v1.1.
- ECOG performance status 0 to 1.
- Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC \>= 1.0 x10\^9/L, platelets \>= 75 x10\^9/L, creatinine clearance \>= 50 mL/min, AST/ALT \<= 3 x ULN, total bilirubin \<= 1.5 x ULN).
- Life expectancy \>= 12 weeks.
- Tumor tissue available (archival or fresh) for antigen profiling (DLL3, CD56/NCAM1, GD2).
- Negative pregnancy test for persons of childbearing potential; agreement to use effective contraception for the protocol-defined duration.
You may not qualify if:
- Active or uncontrolled CNS metastases or leptomeningeal disease (treated/stable CNS metastases may be allowed per protocol).
- Prior treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months (or any prior therapy directed against the investigational target antigens if it would confound safety/efficacy assessment).
- Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease.
- Active uncontrolled infection, including uncontrolled HIV, active hepatitis B or C with viremia, or active tuberculosis.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF \< 45%).
- Active autoimmune disease requiring systemic immunosuppression; chronic systemic corticosteroid use \> 10 mg/day prednisone equivalent (unless for physiologic replacement).
- Concurrent malignancy requiring active treatment (exceptions may apply for certain non-melanoma skin cancers or in situ cancers).
- Pregnant or breastfeeding.
- Any condition that, in the investigator's opinion, would make participation unsafe or interfere with compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Biotechlead
Study Sites (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking is used. Radiographic response assessments may undergo blinded independent central review to support objectivity.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2026
First Posted
March 18, 2026
Study Start
February 2, 2026
Primary Completion (Estimated)
February 14, 2027
Study Completion (Estimated)
April 17, 2028
Last Updated
March 18, 2026
Record last verified: 2026-03