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Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors

ConditionsCancerBreast CancerNon-Small Cell Lung Cancer (NSCLC)Colorectal Cancer (Locally Advanced or Metastatic)Prostate Cancer - RecurrentPancreatic Ductal Adenocarcinoma (PDAC)Ovarian CancerGlioblastomaMelanoma (Skin Cancer)Acute Myeloid Leukemia (AML)Non Hodgkin LymphomaMultiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaLiver Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age8-85
SponsorEssen Biotech

About this trial

This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years.

Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.

Arm A: ≥1 antigen meets "positive" threshold

Arm B: ≥2 antigens meet "positive" threshold

Disqualifiers

Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .

Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).

Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).

Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EB-SELECT Single-Target CAR-NK Cells

    Biological/Vaccine

    Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.

  • Dual-Target Antigen-Selected CAR-NK

    Biological/Vaccine

    Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: Single-Target Antigen-Selected CAR-NKExperimental treatment 1 intervention
Group B: Dual-Target Antigen-Selected CAR-NKExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0

Time frame
28 DAYS
2

Incidence of Dose-Limiting Toxicities (DLTs)

Time frame
28 DAYS

Secondary outcomes

1

Objective Response Rate (ORR) (RECIST 1.1)

Time frame
12 months
2

Disease Control Rate (DCR)

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Essen Biotech

Lead sponsor

Source ClinicalTrials.gov
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