Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG

Launched by CHULALONGKORN UNIVERSITY · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for children with diffuse intrinsic pontine glioma (DIPG), a type of brain tumor that is challenging to treat. The study is testing a special therapy called CAR T-cell therapy, which uses modified immune cells to target and fight the tumor. This trial is in its early phase and aims to determine how safe this treatment is and whether it shows promise in helping children who have already undergone standard treatments, like radiation therapy.

To participate, children aged 1 to 18 with DIPG who have completed their regular treatments may be eligible. They should have a certain type of catheter in place for delivering the therapy and need to be in good overall health, with a life expectancy of at least eight weeks. Participants and their families will be closely monitored throughout the trial, and doctors will assess how well the treatment works and any side effects. It's important to note that the trial has specific requirements, so not all children with DIPG will qualify. Families interested in this study should discuss it thoroughly with their healthcare team to understand the potential benefits and risks involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must have diffuse intrinsic pontine glioma at any timepoint following completion of standard radiotherapy
• • 2. Age 1-18 years
• • 3. Sex: Male or female
• • 4. CNS reservoir catheter, such as an Ommaya or Rickham catheter, present in the proper location for CNS-directed therapy
• • 5. Performance status: Lansky or Karnofsky score \>= 60
• • 6. Life expectancy \>= 8 weeks
• 7. Normal organ function:
• • 7.1 AST (SGOT) \< 5 times the upper limit of normal (ULN) 7.2 ALT (SGPT) \< 5 times the upper limit of normal (ULN) 7.3 Total bilirubin \< 3 times the upper limit of normal (ULN) 7.4 Creatinine \< 5 times the upper limit of normal (ULN) 7.5 SpO2 room air \>=90%
• • 8. Prior therapy wash-out before planned leukapheresis 8.1 \>= 7 days post last chemotherapy/biologic therapy administration 8.2 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy 8.3 At least 30 days from most recent cellular infusion 8.4 All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum dexamethasone dose of 2.5 mg/m2/day. 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 \>= grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention
• • 2. Presence of primary immunodeficiency or bone marrow failure syndrome
• • 3. Presence of clinical and/or radiographic evidence of impending herniation of CNS
• • 4. Presence of \> Grade 3 dysphagia
• • 5. History of active malignancy other than nonmelanoma skin cancer and carcinoma in situ (e.g., cervix, bladder, breast).
• • 6. 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.
• • 7. 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.
• • 8. 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.