Status:
RECRUITING
Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
King Chulalongkorn Memorial Hospital
Conditions:
DIPG Brain Tumor
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief Summary
A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cell with IL-7Ra signal targeting B7H3 in children with diffuse intrinsic pontine glioma (DIPG) patients after complete stan...
Detailed Description
The brain tumor known as Diffuse Intrinsic Pontine Glioma is commonly found in children aged between 5 to 10 years. This type of tumor is aggressive and infiltrates the structures of the brain stem. T...
Eligibility Criteria
Inclusion
- Participants must have diffuse intrinsic pontine glioma at any timepoint following completion of standard radiotherapy
- Age 1-18 years
- Sex: Male or female
- CNS reservoir catheter, such as an Ommaya or Rickham catheter, present in the proper location for CNS-directed therapy
- Performance status: Lansky or Karnofsky score \>= 60
- Life expectancy \>= 8 weeks
- Normal organ function:
- 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%
- 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
- Participants and/or legal guardians must have the ability to understand and willingness to sign a written informed consent and/or assent document
Exclusion
- Presence of \>= grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention
- Presence of primary immunodeficiency or bone marrow failure syndrome
- Presence of clinical and/or radiographic evidence of impending herniation of CNS
- Presence of \> Grade 3 dysphagia
- History of active malignancy other than nonmelanoma skin cancer and carcinoma in situ (e.g., cervix, bladder, breast).
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06221553
Start Date
March 1 2024
End Date
September 1 2026
Last Update
March 30 2025
Active Locations (1)
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1
King Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, Thailand, 10330