NCT06221553 Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG
| NCT ID | NCT06221553 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chulalongkorn University |
| Condition | DIPG Brain Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2024-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 standard treatments.
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.
Contact & Investigator
Piti Techavichit, MD
PRINCIPAL INVESTIGATOR
Chulalongkorn University
Frequently Asked Questions
Who can join the NCT06221553 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying DIPG Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06221553 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06221553 currently recruiting?
Yes, NCT06221553 is actively recruiting participants. Contact the research team at piti.t@chula.ac.th for enrollment information.
Where is the NCT06221553 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT06221553 clinical trial?
NCT06221553 is sponsored by Chulalongkorn University. The principal investigator is Piti Techavichit, MD at Chulalongkorn University. The trial plans to enroll 9 participants.