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

Launched by CHULALONGKORN UNIVERSITY · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called CMD03 CAR T Cell therapy for children and young adults with certain types of solid tumors that have not responded to standard treatments or have come back after treatment. The goal is to see how safe this therapy is and how well it works in these patients. Specifically, the trial focuses on tumors that have a marker called B7-H3, which will be checked using a sample from the patient.

To participate in this trial, patients must be between the ages of 1 and 25 and have a B7-H3 positive tumor that can be measured. They should have experienced a return of their cancer after initial treatment and must have a good performance status, meaning they can perform daily activities with some support. Patients will also need to have normal organ function and have completed prior treatments before starting this trial. Throughout the process, participants will receive careful monitoring and support. It’s important for families to know that there are specific criteria to join, and they will need to provide informed consent before participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Evidence of relapsed or refractory disease after standard first-line therapy
• • 3. Age 1 - 25 years
• • 4. Sex: Male or female
• • 5. Performance status: Lansky or Karnofsky score not less than 50
• • 6. Life expectancy not less than 12 weeks
• • 7. 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%
• • 8. Prior therapy wash-out before planned leukapheresis
• • Not less than 7 days post last chemotherapy/biologic therapy administration
• • 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy
• • At least 30 days from most recent cellular infusion
• • All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/kg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed
• • 9. Participants and/or legal guardians must have the ability to understand and willingness to sign a written informed consent and/or assent document
• Exclusion Criteria:
• • 1. Presence of greater than or equal to grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention
• • 2. Presence of primary immunodeficiency or bone marrow failure syndrome
• • 3. 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
• • 4. 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.
• • 5. 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.