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Taking people in ChinaPhase 1/2

Dual-Target CAR-NK Cell Therapy for Small Cell Lung Cancer That Returned or Resisted Treatment

Tests engineered natural killer cells in adults with relapsed or treatment-resistant small cell lung cancer.

Key facts

Who runs it
Beijing Biotech
Where
Shenzhen, ChinaSee the site
Trial code
Registry title
Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Status
Recruiting
Phase
Phase 1/2
People taking part
60 people, planned
Started
2 Mar 2026
Expected to end
17 Mar 2028
Type of study
Interventional, 3 groups
Treatments tested
  • EB-DART-NK01
  • Lymphodepleting chemotherapy
Record updated
4 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with small cell lung cancer that has come back or has not responded to earlier treatment. It tests CAR-NK cells (immune cells made in a lab) aimed at the cancer.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Small cell lung cancer that is metastatic, extensive-stage or cannot be removed by surgery. At least one lesion that can be measured on scans (RECIST v1.1). ECOG performance status 0 to 1. Life expectancy of at least 12 weeks.
Earlier treatment
Cancer came back or did not respond after at least 1 earlier systemic treatment regimen. This must include a platinum-based regimen unless it was not safe to give. No CAR-T, CAR-NK or other gene-modified cell therapy within 6 months.
Biomarker or test result
Tumor tissue (old or fresh) must be available to test for DLL3, CD56/NCAM1 and GD2.

Main reasons for not taking part

  • Active or uncontrolled cancer spread to the brain or its linings (treated, stable spread may be allowed)
  • Stem cell transplant from a donor within 6 months, or active graft-versus-host disease
  • Uncontrolled infection, such as uncontrolled HIV, active hepatitis B or C, or active tuberculosis
  • Serious heart disease, such as a heart attack within 6 months or LVEF below 45%
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Concurrent malignancy requiring active treatment (exceptions may apply for certain non-melanoma skin cancers or in situ cancers)
  • Active or uncontrolled CNS metastases or leptomeningeal disease (treated/stable CNS metastases may be allowed per protocol)
  • 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
  • Active autoimmune disease requiring systemic immunosuppression; chronic systemic corticosteroid use > 10 mg/day prednisone equivalent (unless for physiologic replacement)
  • Any condition that, in the investigator's opinion, would make participation unsafe or interfere with compliance
  • Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF < 45%)
  • Pregnant or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Peking University Shenzhen HospitalShenzhen, ChinaContact: Zhen J Peng, PhdTaking people

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • DLL3/CD56 Dual-Target CAR-NKTreatment being tested

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

    Treatment: EB-DART-NK01 and Lymphodepleting chemotherapy

  • DLL3/GD2 Dual-Target CAR-NKTreatment being tested

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

    Treatment: EB-DART-NK01 and Lymphodepleting chemotherapy

  • CD56/GD2 Dual-Target CAR-NKTreatment being tested

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

    Treatment: EB-DART-NK01 and Lymphodepleting chemotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Dual-Target CAR-NK Cell Therapy for Small Cell Lung Cancer That Returned or Resisted TreatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07744256, who can take part
Record updated
4 August 2026