NCT07744256

Brief Summary

This example 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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 2, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2028

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Small Cell Lung Cancer (SCLC)Relapsed/Refractory SCLCExtensive-stage SCLC

Keywords

CAR-NKDual-targetAdoptive cell therapyImmunotherapySolid tumorSmall cell lung cancerDLL3CD56 (NCAM1)GD2

Outcome Measures

Primary Outcomes (2)

  • Incidence of dose-limiting toxicities

    28 Days

  • maximum tolerated dose (MTD)

    maximum tolerated dose (MTD) of the drug

    12 months

Secondary Outcomes (2)

  • Objective response rate

    12 months

  • Disease control rate

    12 months

Study Arms (3)

DLL3/CD56 Dual-Target CAR-NK

EXPERIMENTAL

Allogeneic dual-target CAR-NK cells targeting DLL3 and CD56 (NCAM1) following lymphodepleting chemotherapy.

Biological: EB-DART-NK01Drug: Lymphodepleting chemotherapy

DLL3/GD2 Dual-Target CAR-NK

EXPERIMENTAL

Allogeneic dual-target CAR-NK cells targeting DLL3 and GD2 following lymphodepleting chemotherapy.

Biological: EB-DART-NK01Drug: Lymphodepleting chemotherapy

CD56/GD2 Dual-Target CAR-NK

EXPERIMENTAL

Allogeneic dual-target CAR-NK cells targeting CD56 (NCAM1) and GD2 following lymphodepleting chemotherapy.

Biological: EB-DART-NK01Drug: Lymphodepleting chemotherapy

Interventions

Lymphodepleting chemotherapyDRUG

An alkylating chemotherapy agent used as part of lymphodepleting conditioning prior to CAR-NK cell infusion to enhance cell expansion, persistence, and anti-tumor activity.

CD56/GD2 Dual-Target CAR-NKDLL3/CD56 Dual-Target CAR-NKDLL3/GD2 Dual-Target CAR-NK
EB-DART-NK01BIOLOGICAL

Allogeneic dual-target CAR-NK cells engineered to enhance tumor recognition and cytotoxicity against heterogeneous solid tumors.

CD56/GD2 Dual-Target CAR-NKDLL3/CD56 Dual-Target CAR-NKDLL3/GD2 Dual-Target CAR-NK

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung CarcinomaRecurrence

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

shan S Lu, Phd

CONTACT

+86 13076790030Seni-Lu@beijing-biotech.com

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
PARALLEL
Model Details: During Phase 1, participants are treated in one of three arms corresponding to a dual-target CAR-NK construct. Assignment is non-randomized and guided by tumor antigen profiling (and/or slot availability). After interim analysis, one construct is selected for Phase 2 expansion at RP2D.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

February 14, 2027

Study Completion (Estimated)

March 17, 2028

Last Updated

August 4, 2026

Record last verified: 2026-07

Locations

CN(1)