Health TrialsbyHealthPanel

Dual-target CD70/CAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma

ConditionAdvanced or Metastatic Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Biotech

About this trial

Phase 1/2 study evaluates the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CD70/CAIX CAR-NK cells after fludarabine/cyclophosphamide lymphodepletion in adults with advanced or metastatic clear cell RCC that has progressed after standard therapy. The study is designed to determine a recommended dose and schedule, characterize hepatobiliary safety, and explore whether CD70-high, CAIX-high, or dual-high tumors derive the greatest benefit. Biomarker-defined activity signals will be used to guide whether later development should prioritize CD70, CAIX/CA9, or continued dual-targeting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and willingness to comply with protocol procedures.

Age >= 18 years at the time of consent.

Histologically confirmed unresectable or metastatic clear cell RCC, or RCC with a clear-cell component, with radiographic progression after standard therapy.

Prior exposure to at least one PD-1 / PD-L1-based regimen and at least one VEGF-pathway targeted regimen, or documented intolerance / unsuitability for available standard systemic options.

Disqualifiers

Active, untreated, or symptomatic central nervous system metastases, leptomeningeal disease, or uncontrolled seizure disorder.

Prior gene-modified cellular therapy (including prior CAR-T, CAR-NK, CAR-NKT, or TCR-engineered therapy) within the protocol-defined washout window.

Prior allogeneic stem cell transplant or solid organ transplant with ongoing clinically significant immunosuppression.

Active autoimmune disease requiring systemic immunosuppressive treatment; physiologic replacement doses are permitted.

Trial design

Design model

Single group

Treatments tested in this trial

  • EB-701/CA9-NK

    Biological/Vaccine

    dual-target allogeneic CAR-NK cells (single infusion on Day 0; optional second infusion on Day 15 if safety criteria are met)

  • Fludarabine

    Drug

    lymphodepletion

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Experimental: Dual-target CD70/CAIX CAR-NK cells after lymphodepletionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Incidence of dose-limiting toxicities (DLTs) during the DLT window, graded by CTCAE v5.0

Time frame
28 Days
2

Determination of recommended phase 2 dose

Time frame
8 weeks

Secondary outcomes

1

Objective response rate (ORR) per RECIST 1.1 by independent radiologic review

Time frame
6 months
2

Overall Survival (OS)

Overall Survival (OS) is the length of time from diagnosis or treatment start that patients remain alive

Time frame
12 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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