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

NCT06612645 | Recruiting Phase 1 DMC

• 2 other identifiers: LV-CMD03-PST-P1-2024Chulalongkorn University
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancers; Solid Tumor Pediatric

Keywords

CAR T cell; B7H3; IL-7 receptor alpha; Chimeric antigen receptor T cell; Adoptive cellular therapy; Solid tumor pediatric

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of B7H3-IL7Ra CAR T cells infusion in solid tumors patients.

  The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

  7 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months and 12 months after B7H3-IL7Ra CAR-T cell infusion

Secondary Outcomes (1)

• The overall response rate of solid tumors

  1, 3, 6, and 12 months after B7H3-IL7Ra CAR-T cell infusion

Other Outcomes (2)

• The persistence and distribution of B7H3-IL7Ra CAR T cells in the peripheral blood

  7 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months and 12 months after B7H3-IL7Ra CAR-T cell infusion

• Serum cytokine level measurement

  7 days, 14 days, 21 days and 30 days after B7H3-IL7Ra CAR-T cell infusion

Study Arms (1)

B7H3/IL-7Ra CAR T cell in Solid tumors

EXPERIMENTAL

B7H3-specific chimeric antigen receptor (CAR) T cell with additional of IL-7Ra signaling domain Dose level: 1x10e6 cells/kg, 3x10e6 cells/kg, 10x10e6 cells/kg

Biological: B7H3-IL7Ra CAR-T cells

Interventions

B7H3-IL7Ra CAR-T cells BIOLOGICAL

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

B7H3/IL-7Ra CAR T cell in Solid tumors

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must have B7-H3 positive solid tumor with measurable disease.
• \- B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) or flow cytometry using a previously obtained sample.
• Evidence of relapsed or refractory disease after standard first-line therapy
• Age 1 - 25 years
• Sex: Male or female
• Performance status: Lansky or Karnofsky score not less than 50
• Life expectancy not less than 12 weeks
• Normal organ function
• AST (SGOT) below 5 times the upper limit of normal (ULN)
• ALT (SGPT) below 5 times the upper limit of normal (ULN)
• Total bilirubin below 3 times the upper limit of normal (ULN)
• Creatinine below 5 times the upper limit of normal (ULN)
• SpO2 room air not less than 90%
• Prior therapy wash-out before planned leukapheresis
• Not less than 7 days post last chemotherapy/biologic therapy administration

You may not qualify if:

• Presence of greater than or equal to grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention
• Presence of primary immunodeficiency or bone marrow failure syndrome
• Presence of uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breastfeeding women were excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment in this study and for four months after receiving CAR-T-cell infusion.
• Serologic status reflecting active HIV, hepatitis B or C infection. Participants who are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to enrollment.

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: collaborator
• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Pathumwan, 10330, Thailand

RECRUITING

Study Officials

• Piti Techavichit, Associate Professor, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piti Techavichit, Associate Professor, MD

CONTACT

+66817515363; Piti.T@chula.ac.th

Koramit Suppipat, MD

CONTACT

+66816282068; Koramit.S@chula.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3+3 dose escalation study

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 25, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)