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Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)

ConditionsSmall Cell Lung Cancer (SCLC)Relapsed/Refractory SCLCSCLC, Extensive Stage
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

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

  • Lymphodepleting chemotherapy

    Drug

    (fludarabine + cyclophosphamide)

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: DLL3/CD56 Dual-Target CAR-NK (EB-DART-NK01)Experimental treatment 2 interventions
Group B: DLL3/GD2 Dual-Target CAR-NK (EB-DART-NK02)Experimental treatment 2 interventions
Group C: CD56/GD2 Dual-Target CAR-NK (EB-DART-NK03)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Time frame
28 Days
2

Maximum tolerated dose (MTD)

Time frame
12 months

Secondary outcomes

1

Objective response rate (ORR)

Time frame
12 months
2

Progression-free survival (PFS)

Time frame
24 months
3

Overall survival (OS)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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