Health Trials

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EB-DART-NK01 (DLL3/CD56 CAR-NK cells)
  • Lymphodepleting chemotherapy

Treatment groups

60 Participants
are divided into 3 treatment groups

Locations

1
Peking University Shenzhen Hospital518036, ShenzhenGuangdong, China

Sponsors and collaborators

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov