BridgeMD
New treatment option for Diffuse Midline Glioma, H3 K27M-Mutant
Official title CAR T Cells to Target GD2 for DMG
ClinicalTrials.gov ID: NCT05544526
What this study is testing
What is GD2 CAR T cells?
GD2 CAR T cells is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for diffuse midline glioma, h3 k27m-mutant.
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 CARMIGO Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults aged 2-16 years with Diffuse Midline Glioma (DMG). The study will evaluate the feasibility of generating the ATIMP, the safety and tolerability of the GD2CAR T-cell therapy and how effectively GD2CAR T-cells engraft, expand and persist following administration in patients with DMG.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 16
You may be able to join if
- Age ≥ 2 and ≤ 16 years
- Tissue diagnosis of H3K27M mutant Diffuse Midline Glioma.
- Radiographically evident tumour restricted to the brain stem or spinal cord.
- At least 6 weeks following completion of radiation therapy.
- At least 3 weeks or 5 half-lives, whichever is shorter, after treatment with agents on other early phase clinical trial
You likely can't join if
- Systemic corticosteroid therapy ≥ 0.05 mg/kg dexamethasone daily (or equivalent) at time of RQR8/huK28Z CAR T cell infusion
- Tumour involvement of the thalamus or supratentorial lesions, cerebellar vermis or hemispheres (pontocerebellar peduncle involvement is allowed)
- Clinical or radiological evidence of true tumour progression
- Active hepatitis B, C or HIV infection
- Inability to tolerate leukapheresis
- Pre-existing significant neurological disorder not related to DMG
See the full eligibility criteria
- Age ≥ 2 and ≤ 16 years
- Tissue diagnosis of H3K27M mutant Diffuse Midline Glioma.
- Radiographically evident tumour restricted to the brain stem or spinal cord.
- At least 6 weeks following completion of radiation therapy.
- At least 3 weeks or 5 half-lives, whichever is shorter, after treatment with agents on other early phase clinical trial
- Performance status: Karnofsky (age ≥ 10 years) or Lansky (age \< 10) score ≥ 40% allowing for stable neurological deficit due to DMG
- Absolute neutrophil count ≥1.5 x109/L and platelet count ≥ 100 x109/L
- Total bilirubin \< 1.5 ULN and ALT \< 2.5 ULN
- Serum creatine \< 1.5 ULN for age.
- For post-pubertal people agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
- Systemic corticosteroid therapy ≥ 0.05 mg/kg dexamethasone daily (or equivalent) at time of RQR8/huK28Z CAR T cell infusion
- Tumour involvement of the thalamus or supratentorial lesions, cerebellar vermis or hemispheres (pontocerebellar peduncle involvement is allowed)
- Clinical or radiological evidence of true tumour progression
- Active hepatitis B, C or HIV infection
- Inability to tolerate leukapheresis
- Pre-existing significant neurological disorder not related to DMG
- Clinically significant systemic illness or medical condition (e.g., significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgement of the investigator is likely to interfere with assessment...
- Any contraindication to lymphodepletion or to the use of Cyclophosphamide or Fludarabine as per the local SmPC
- Any contraindication to the use of Anticoagulant Citrate Dextrose Solution
- Any contraindication to Ommaya reservoir insertion (or similar catheter)
- Known allergy to albumin, DMSO or EDTA
- Primary immunodeficiency or history of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression /systemic disease modifying agents within the last 2 years
- Prior treatment with investigational or approved gene therapy or cell therapy products
- Life expectancy \<3 months
- Use of rituximab (or rituximab biosimilar) within the last 3 months prior to RQR8/huK28Z CAR T cell infusion
- Post-pubertal people who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, up to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. 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.