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New treatment option for Glioma of Spinal Cord
Official title GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
ClinicalTrials.gov ID: NCT04196413
What this study is testing
What is GD2 CAR T cells?
GD2 CAR T cells is an investigational medicine, being studied as a potential treatment for glioma of spinal cord.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to test whether CAR T cells targeting GD2 (GD2CART) can be successfully made and safely given to children and adults with H3K27M-mutant diffuse midline glioma (DMG). Eligible subjects may have DMG arising in the pons (called difuse intrinisic pontine glioma, DIPG), the spinal cord, or other areas of the brain such as a thalamus
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 60
You may be able to join if
- Disease Status: Diagnosis of H3K27M mutant diffuse midline glioma (DMG)
- H3K27M or H3K27I mutation. Confirmed by CLIA test.
- Age: Greater than or equal to 2 year of age and less than or equal to 60 years of age.
- Prior Therapy:
- At least 4 weeks following completion of standard upfront radiation therapy.
You likely can't join if
- For Dose Escalation: Bulky tumor involvement of cerebellar vermis or hemispheres (pontocerebellar peduncles involvement is acceptable), or thalamic...
- Clinically significant swallowing dysfunction/dysphagia or prominent medullary dysfunction, as determined by the clinical investigator; or primary...
- Current systemic corticosteroid therapy above physiologic replacement levels.
- Ongoing use of dietary supplements, alternative therapies or extreme diet modifications or any medication not approved by the investigators
- Prior CAR therapy.
- Prior immunomodulatory therapy, except for checkpoint inhibitor therapy after at least 3 month wash-out.
See the full eligibility criteria
- Disease Status: Diagnosis of H3K27M mutant diffuse midline glioma (DMG)
- H3K27M or H3K27I mutation. Confirmed by CLIA test.
- Age: Greater than or equal to 2 year of age and less than or equal to 60 years of age.
- Prior Therapy:
- At least 4 weeks following completion of standard upfront radiation therapy.
- At least 3 weeks post chemotherapy or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy, except for systemic inhibitory/stimulatory immune checkpoint therapy that requires 3 months.
- Dordaviprone (Modeyso), previously known as ONC201, may be taken as prior therapy but - just as with other anti-cancer medications - administration must cease at least 5 half-lives prior to enrollment
- Performance Status: people \> 16 years of age: Karnofsky ≥ 60% OR Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; people ≤ 16 years of age: Lansky scale ≥ 60%. people who are unable to walk...
- Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion) i. ANC ≥ 1000/uL ii. Platelet count ≥ 100,000/uL iii. Absolute lymphocyte count ≥ 150/uL iv...
- Total bilirubin ≤ 1.5 mg/dl, except in people with Gilbert's syndrome.
- Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings
- Baseline oxygen saturation \> 92% on room air
- Pregnancy Test Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization are not considered to be of childbearing potential) or NA
- Contraception people of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen or...
- Ability to give informed consent. All people ≥ 18 years of age must be able to give informed consent. For people \ 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he/she...
- For Dose Escalation: Bulky tumor involvement of cerebellar vermis or hemispheres (pontocerebellar peduncles involvement is acceptable), or thalamic lesions that in the investigator's assessment place the subject at...
- Clinically significant swallowing dysfunction/dysphagia or prominent medullary dysfunction, as determined by the clinical investigator; or primary cervical cord tumors above C6/7 that represent a high risk of...
- Current systemic corticosteroid therapy above physiologic replacement levels.
- Ongoing use of dietary supplements, alternative therapies or extreme diet modifications or any medication not approved by the investigators
- Prior CAR therapy.
- Prior immunomodulatory therapy, except for checkpoint inhibitor therapy after at least 3 month wash-out.
- Uncontrolled fungal, bacterial, viral, or other infection. Previously diagnosed infection for which the patient continues to receive antimicrobial therapy is permitted if responding to treatment and clinically stable.
- Diagnosed ongoing infection with:
- HIV,
- Hepatitis B (HBsAg positive) or
- Hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
- Clinically significant systemic illness or medical condition (e.g. significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgement of the principal investigator is likely to interfere with...
- Women who are pregnant or breastfeeding.
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
- Known sensitivity or allergy to any agents/reagents used in this study.
- Primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
- All subject files must include supporting documentation to confirm subject eligibility. The method of confirmation can include, but is not limited to, laboratory test results, radiology test results, subject...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.