NCT06612645

Safety and Efficacy of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors

Safety and Efficacy of B7H3 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD03) in Relapse and Refractory Pediatric Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after complete standard treatments.

Detailed description

Currently, treatment options for pediatric solid tumors that have recurred or are unresponsive to standard treatments are limited. These cancers often do not respond to other chemotherapy drugs or targeted therapies available today. As a result, there is currently no effective treatment for pediatric solid tumors that have recurred or are unresponsive to standard treatments. At present, immunotherapy for cancer treatment is being developed. This involves genetically modifying the patient\'s immune cells to target specific cancer cells, known as CAR T cells. This approach is used to treat recurrent or unresponsive solid tumors and brain cancers that do not respond to standard treatments. The research aims to study the efficacy and safety of treating pediatric patients with recurrent or unresponsive solid tumors using a type of immunotherapy called CAR T cells. These cells are engineered to express a chimeric antigen receptor that includes an interleukin-7 receptor alpha signaling domain and targets the B7-H3 antigen on tumor surfaces. This research is the first of its kind conducted on Thai patients. The research team expects this treatment to be highly safe and effective in controlling cancer.

Conditions

• Pediatric Cancers
• Solid Tumor Pediatric

Interventions

Type	Name	Description
BIOLOGICAL	B7H3-IL7Ra CAR-T cells	Autologous T cells lentiviral transduced to express a B7H3-specific chimeric antigen receptor (CAR) with the addition of an IL-7 receptor alpha signaling domain, administered via central venous access catheter after lymphodepletion

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-09-25
• Last updated: 2026-03-02

Locations

1 site across 1 country: Thailand