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Safety Trial, DSC vs. BAT in SR acute GvHD
EU CTIS ID: 2024-511768-97-01
What this study is testing
To assess the safety and tolerability of DSC To assess Durable Overall Response Rate (DOR) at Day 56
- 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
- Study informed consent form signed by the patient her-/himself.
- Male or female patients aged 18 or older at the time of informed consent
- Have undergone HSCT from any donor source (unrelated, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non- myeloablative, myeloablative, and reduced intensity conditioning are eligible
- Clinically diagnosed Grades II to IV acute GvHD as per standard criteria (Appendix 1) occurring after HSCT requiring systemic immune suppressive therapy. Biopsy of involved organs with aGvHD is encouraged but not required for study screening.
- Confirmed diagnosis of steroid refractory aGvHD defined as patients administered high dose systemic corticosteroids (methylprednisolone ≥1 mg/kg/day (±20%) [or equivalent prednisone dose ≥1.25 mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either: A. A Progression based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR B. Failure to achieve at a minimum partial response based on organ assessment after 5-7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR C. Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria: 1. Requirement for an increase in the corticosteroid dose to methylprednisolone ≥1 mg/kg/day (or equivalent prednisone dose ≥1.25 mg/kg/day) OR 2. Failure to taper the methylprednisolone dose to <0.5 mg/kg/day (or equivalent prednisone dose <0.6 mg/kg/day) for a minimum 7 days
You likely can't join if
- Has received systemic treatment for aGvHD apart from steroids. Standard aGvHD prophylaxis and treatment medications initiated before randomization including systemic corticosteroids, calcineurin inhibitors (CNI) (cyclosporine, tacrolimus or Mycofenolate Mofetil (MMF)), and topical corticosteroid therapy may be continued, per institutional guidelines.
- Any corticosteroid therapy for indications other than aGvHD at doses > 1 mg/kg/day methylprednisolone (or equivalent prednisone dose 1.25 mg/kg/day) within 7 days of Screening. Routine corticosteroids administered during conditioning or cell infusion is allowed.
- History of progressive multifocal leuko-encephalopathy (PML).
- Previous participation in a study of any investigational treatment agent within 30 days or within 5 half-lives of the study treatment, whichever is greater.
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the patient; or interfere with interpretation of study data.
- Known allergies, hypersensitivity, or intolerance to systemic immunosuppressive therapy
See the full eligibility criteria
Who can join
- Study informed consent form signed by the patient her-/himself.
- Male or female patients aged 18 or older at the time of informed consent
- Have undergone HSCT from any donor source (unrelated, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non- myeloablative, myeloablative, and reduced intensity conditioning are eligible
- Clinically diagnosed Grades II to IV acute GvHD as per standard criteria (Appendix 1) occurring after HSCT requiring systemic immune suppressive therapy. Biopsy of involved organs with aGvHD is encouraged but not required for study screening.
- Confirmed diagnosis of steroid refractory aGvHD defined as patients administered high dose systemic corticosteroids (methylprednisolone ≥1 mg/kg/day (±20%) [or equivalent prednisone dose ≥1.25 mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either: A. A Progression based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR B. Failure to achieve at a minimum partial response based on organ assessment after 5-7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR C. Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria: 1. Requirement for an increase in the corticosteroid dose to methylprednisolone ≥1 mg/kg/day (or equivalent prednisone dose ≥1.25 mg/kg/day) OR 2. Failure to taper the methylprednisolone dose to <0.5 mg/kg/day (or equivalent prednisone dose <0.6 mg/kg/day) for a minimum 7 days
What rules you out
- Has received systemic treatment for aGvHD apart from steroids. Standard aGvHD prophylaxis and treatment medications initiated before randomization including systemic corticosteroids, calcineurin inhibitors (CNI) (cyclosporine, tacrolimus or Mycofenolate Mofetil (MMF)), and topical corticosteroid therapy may be continued, per institutional guidelines.
- Any corticosteroid therapy for indications other than aGvHD at doses > 1 mg/kg/day methylprednisolone (or equivalent prednisone dose 1.25 mg/kg/day) within 7 days of Screening. Routine corticosteroids administered during conditioning or cell infusion is allowed.
- History of progressive multifocal leuko-encephalopathy (PML).
- Previous participation in a study of any investigational treatment agent within 30 days or within 5 half-lives of the study treatment, whichever is greater.
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the patient; or interfere with interpretation of study data.
- Known allergies, hypersensitivity, or intolerance to systemic immunosuppressive therapy
- Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
- Known hypersensitivity to trace amounts of Gentamycin
- Patients with coagulopathy (eg. hemofilia), history of past thrombo-embolic event (eg. deep venous thrombosis, lung embolism, cerebral thrombo-embolism) in the previous 3 months
- Uncontrolled hypertension
- History of severe chronic heart disease (documented ejection fraction ≤ 30% or NYHA > II), recent MI (6 months) or unstable angina, clinically significant (symptomatic) cardiac arrhythmias, lung disease (requiring home oxygen), pulmonary hypertension (RVSP > 50 on prior ECHO), or liver comorbidities (MELD score <10).
- Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features (as defined by Jagasia, et al. 2015)
- Pregnant or nursing (lactating) women OR Female patients ≥ 18 years of age and of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception as defined below, throughout the study and for up to 90 days after stopping treatment.
- Sexually active men and male adolescents who do not agree to use condom during intercourse, if applicable and for up to 90 days after stopping treatment and/or wish to father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid.
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral (CMV, EBV, HHV-6, HBV, or HCV) or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Known human immunodeficiency virus infection (HIV).
- Patients suffering on active tuberculosis or viral hepatitis
- Significant respiratory disease including patients who are on mechanical ventilation or who have resting O2 saturation <90% by pulse-oximetry.
- Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8 μmol/L), renal dialysis requirement, or have estimated creatinine clearance <30 ml/min measured or calculated by Cockroft Gault equation (confirmed within 48h prior to study treatment start).
- Presence of severely impaired liver function not due to liver GVHD defined by ALT / AST> 5 times the upper limit of the normal.
- Malignancy (except the HSCT indication) that has required treatment in the previous two years (excluding non-melanoma skin malignancies treated by excision, or cryotherapy)
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, 18-64 years, 65+ 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.