Health TrialsbyHealthPanel

Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma

ConditionsUnresectable MelanomaMetastatic Cutaneous MelanomaMetastatic Uveal Melanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech

About this trial

This is a first-in-human, open-label, multicenter phase 1/2 study evaluating the safety, feasibility, recommended phase 2 dose (RP2D), and preliminary antitumor activity of allogeneic dual-target CSPG4/GD2 CAR-NK cells (EBDTKN-401) after lymphodepleting chemotherapy in adults with unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years at consent.

Histologically confirmed unresectable/metastatic cutaneous melanoma or metastatic uveal melanoma.

Disease progression after standard therapy, intolerance to standard therapy, or no remaining standard option expected to provide meaningful benefit. For cutaneous melanoma: prior anti-PD-1/L1 (with or without antiCTLA-4) unless contraindicated; if BRAF V600-mutant, prior BRAF/MEK inhibitor therapy or documented unsuitability. For uveal melanoma: prior tebentafusp if HLA-A*02:01-positive and eligible, or documented unsuitability/unavailability plus at least one prior systemic therapy.

Tumor demonstrates CSPG4 and/or GD2 expression in archival or fresh tissue by central testing (suggested positivity threshold: at least 25% viable tumor cells by IHC or equivalent validated assay).

Disqualifiers

Active symptomatic CNS metastases, leptomeningeal disease, or uncontrolled seizure disorder.

Prior allogeneic stem cell transplant or solid organ transplant; prior gene-modified cellular therapy within 12 weeks; or anti-cancer therapy too close to lymphodepletion per protocol washout rules.

Requirement for systemic immunosuppression greater than 10 mg prednisone equivalent/day or uncontrolled autoimmune/inflammatory disease requiring systemic treatment.

Active uncontrolled infection, including uncontrolled HIV, HBV, or HCV, or fever/sepsis at the time lymphodepletion would begin.

Trial design

Design model

Sequential

Treatments tested in this trial

  • EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells

    Biological/Vaccine

    Genetically engineered natural killer (NK) cells expressing dual chimeric antigen receptors targeting CSPG4 and GD2 are expanded ex vivo and infused (IV) into patients. These cells recognize tumor antigens and induce targeted cytotoxicity, aiming to improve tumor killing and reduce antigen escape in CSPG4/GD2-positive cancers.

  • Fludarabine

    Drug

    Fludara

  • Cyclophosphamide

    Drug

    Cyclophosphamide

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Arm A: Dose-escalation safety lead-inExperimental treatment 3 interventions
Group B: Arm B: Cutaneous expansionExperimental treatment 3 interventions
Group C: Arm C:Uveal expansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs) using CTCAE v5.0

Time frame
28 Days
2

Recommended Phase 2 Dose (RP2D)

Time frame
42 Days

Secondary outcomes

1

Treatment-emergent adverse events ( TEDE )

Treatment-emergent adverse events including CRS, ICANS, prolonged cytopenias, neuropathic pain, ocular toxicity, and GVHD

Time frame
12 Month
2

Objective response rate (ORR) by RECIST v1.1

Time frame
12 Month
3

Disease control rate (DCR) by RECIST v1.1

Time frame
12 Month
4

Duration of response

Time frame
24 Month

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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