Multi-modular Chimeric Antigen Receptor T Cells tarGeting B7-H3 in Children, Teenage & Young Adult Sarcoma

Sponsor
University College, London
Study ID
NCT07751380
Phase
PHASE1
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Biological/Vaccine: hBRCA84D CAR T cells — DRUG
    The hBRCA84D CAR T cells target B7-H3 positive cells.

Study Details

MIGHTY is a multicentre, open label, phase 1 clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children, teenagers and young adults aged 1-24 with relapsed or refractory (r/r) rhabdomyosarcoma (RMS), Ewing sarcoma (ES) or desmoplastic small round cell tumour (DSRCT). The study will assess the feasibility of generating the ATIMP and administering hBRCA84D CAR T cells to patients with r/r RMS, ES or DSRCT.

Key Dates

First listed
Aug 7, 2026
Start date
Jul 23, 2025
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2042

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: hBRCA84D CAR T cells
    Treatment with hBRCA84D CAR T cells

Primary Outcome Measure

Safety of administering the ATIMP [ Time Frame: 28 days ]

Central Contacts

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