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A medical research to evaluate if MaaT013 is safe and helps children and adolescent with GI-aGvHD after failed two prior therapies.
EU CTIS ID: 2025-524302-15-00
What this study is testing
Co- Primary: Safety and tolerability of MaaT013 Feasibility of MaaT013 administration in paediatric population
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 6 years and < 18 years old at the time point of informed consent.
- 9. Signature of informed and written consent / assent by the participants legal representative.
- 11. Use of an acceptable effective method of birth control for the course of the study for female of childbearing potential/sexually active male with partner of childbearing potential. This includes, but is not limited to: a) progestogen-only oral hormonal contraception b) male or female condom with or without spermicide c) cap, diaphragm or sponge with spermicide d) A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable birth control methods
- 10. Negative urine or serum pregnancy test for females of childbearing potential within 72 hours prior to receiving the first dose of MaaT013 treatment.
- 2. Karnofsky/Lansky performance status ≥ 40 at informed consent.
- 3. Weight ≥ 15 kg.
You likely can't join if
- 1. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management. Isolated urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
- 2. Any other diseases, metabolic dysfunction, physical examination findings, or clinical laboratory abnormalities giving reasonable suspicion of a disease or condition that in the opinion of the investigator would contraindicate study treatment.
- 3. Clinical presentation resembling de novo cGvHD or GvHD overlap syndrome with both acute and chronic GvHD features
- 4. Known hypersensitivity to vancomycin or to any of the excipients listed in the corresponding SmPC.
- 5. Active cytomegalovirus (CMV) colitis.
- 6. Relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
See the full eligibility criteria
Who can join
- 1. Age ≥ 6 years and < 18 years old at the time point of informed consent.
- 9. Signature of informed and written consent / assent by the participants legal representative.
- 11. Use of an acceptable effective method of birth control for the course of the study for female of childbearing potential/sexually active male with partner of childbearing potential. This includes, but is not limited to: a) progestogen-only oral hormonal contraception b) male or female condom with or without spermicide c) cap, diaphragm or sponge with spermicide d) A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable birth control methods
- 10. Negative urine or serum pregnancy test for females of childbearing potential within 72 hours prior to receiving the first dose of MaaT013 treatment.
- 2. Karnofsky/Lansky performance status ≥ 40 at informed consent.
- 3. Weight ≥ 15 kg.
- 4. Allo-HSCT with any type of donor, stem cell source, GvHD prophylaxis or conditioning regimen.
- 5. Acute GvHD episode with GI involvement per MAGIC guidelines (= grade II to IV), with or without involvement of other organs
- 6. Adequate organ function, defined as: o Absolute neutrophil count (ANC) >500/µl, confirmed within 3 days prior to pre-treatment start. Use of growth factor supplementation to support the ANC count is allowed. o Platelet count > 10.000/µl, confirmed within 3 days prior to pre-treatment start. Use of platelet transfusion to support the platelet count is allowed.
- 7. Resistance to steroids and ruxolitinib. Resistance to steroids is defined as participants administered high-dose systemic CS (methylprednisolone 2 mg/kg/day – or equivalent prednisone dose 2.5 mg/kg/day), given alone or combined with CNI or mechanistic Target of Rapamycin (mTOR) inhibitor and either: o Lack of improvement (i.e., no decrease in stage in at least 1 involved organ system) after ≥ 5 days of treatment with CS at 2 mg/kg/d methylprednisolone equivalent dose, OR o Progression (i.e., increase of GvHD in any organ system or any new organ involvement) after ≥ 3 days of treatment with CS at 2 mg/kg/d methylprednisolone equivalent dose, OR o Participants treated with 1 mg/kg/d of CS as deemed intolerant by investigator to a dose of 2 mg/kg/d, and who correspond to the definition of SR participants, OR o Participants who previously began CS therapy at a lower dose (at least 1 mg/kg/d methylprednisolone equivalent) for skin or upper GI-GvHD but develop new GvHD in another organ system, OR o Participants intolerant to CS tapering, i.e., begin of CS at 2.0 mg/kg/d, demonstrate response, but show disease progression before a 50% decrease from the initial starting dose of CS is achieved. Resistance to ruxolitinib is defined as any of the following (adapted from (Mohty et al. 2020)): o Progression of GvHD compared to baseline after at least 5 days of treatment with ruxolitinib, based either on objective increase in stage/grade, or new organ involvement; or a lack of improvement for patients already at the highest stage or grade. OR o Lack of improvement in GvHD (PR or better) compared to baseline after at least 14 days of treatment with ruxolitinib, OR o Loss of response, defined as objective worsening of GvHD determined by increase in stage, grade or new organ involvement at any time after initial improvement, OR o Absence of CR or VGPR at D28 after ruxolitinib start. Intolerance to ruxolitinib is defined as: o GvHD manifestations that persist without improvement in participants who had grade 3 or higher ruxolitinib-emergent and ruxolitinib-attributed AE that did not resolve within 7 days of discontinuing ruxolitinib.
- 8. Allo-HSCT participants with a non-malignant underlying disease may be enrolled only after their eligibility has been reviewed and approved by a multidisciplinary clinical board at clinical site.
What rules you out
- 1. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management. Isolated urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
- 2. Any other diseases, metabolic dysfunction, physical examination findings, or clinical laboratory abnormalities giving reasonable suspicion of a disease or condition that in the opinion of the investigator would contraindicate study treatment.
- 3. Clinical presentation resembling de novo cGvHD or GvHD overlap syndrome with both acute and chronic GvHD features
- 4. Known hypersensitivity to vancomycin or to any of the excipients listed in the corresponding SmPC.
- 5. Active cytomegalovirus (CMV) colitis.
- 6. Relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
- 7. Previous lines of systemic aGvHD treatment other than CS and ruxolitinib.
- 8. Severe organ dysfunction or other uncontrolled complication, unrelated to underlying GvHD, including: cholestatic disorders or unresolved veno-occlusive disease (VOD) of the liver (defined as persistent bilirubin abnormalities not attributable to GvHD and ongoing organ dysfunction, with the exception of Gilbert syndrome).
- 9. Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months before Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support that requires therapy.
- 18. For France only: Children who are, or who are expected to become, adults under legal protection (tutelle, curatelle, or other court‑ordered protection), children whose parents are not affiliated with a French social security scheme and who therefore cannot be enrolled as dependents (‘ayants droit’), or children who would not be eligible for health coverage under the Protection Universelle Maladie (PUMA) upon reaching 18 years of age.
- 10. Clinically significant respiratory disease that requires mechanical ventilation support or oxygen support with a fraction of inspired oxygen at 50%.
- 11. Current or past (<6 months) evidence of toxic megacolon, bowel obstruction or GI perforation
- 12. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- 13. Known allergy or intolerance to trehalose or maltodextrin.
- 14. Breastfeeding females.
- 15. Participant having received any previous microbiome product (FMT). Note: Participants with medical history of probiotic intake are eligible.
- 16. Other ongoing interventional protocol that might interfere with the current study’s primary and secondary endpoints.
- 17. In the investigator’s judgement, the participant is unlikely to complete all protocol-requiring trial visits or procedures, including FU visits, or comply with the trial requirements for participation.
The study team makes the final eligibility decision.
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.