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New treatment option for cGVHD
Official title Treatment of Refractory cGVHD by Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2
ClinicalTrials.gov ID: NCT06920199
What this study is testing
What is Donor-derived Treg cell injection combined with interleukin 2?
Donor-derived Treg cell injection combined with interleukin 2 is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for cgvhd.
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
- This study is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, tolerability, changes and persistence of peripheral blood Treg cells, and pharmacodynamic characteristics of donor-derived Treg cell injection combined with recombinant human interleukin-2 in treating subjects with refractory cGVHD，and to preliminarily observe the efficacy of the study drugs in subjects with refractory cGVHD.
- 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 18 to 70
You may be able to join if
- people aged 18-70 years old, male or female;
- The people had received allo-HSCT, including cord blood transplantation;
- TSubjects with moderate/severe cGVHD that meets the NIH diagnostic criteria (031) for steroid dependence or resistance, meeting one of the following:
- There was no improvement in cGVHD in initial treatment patients treated with \> 0.5mg/kg/ day or 1 mg/kg/ day every other day for at least 4 weeks;
- Steroid dependence: predtisone dose \> 0.25 mg/kg/d or \> 0.5 mg/kg/qod cGVHD relapse or progression; cGVHD recurred after two attempts to gradually...
You likely can't join if
- people had a recurrence of primary malignant disease before receiving Treg treatment;
- The people had persistent, recurrent or delayed aGVHD;
- Continuous use of prednisone \>1 mg/kg/day is required;
- The severity of the subject's cGVHD cannot be assessed by physical examination or laboratory examination;
- overlap syndrome；
- The people had major organ (cardio-cerebrovascular, pulmonary) dysfunction not caused by cGVHD, and had previous (within 3 months) gastrointestinal...
See the full eligibility criteria
- people aged 18-70 years old, male or female;
- The people had received allo-HSCT, including cord blood transplantation;
- TSubjects with moderate/severe cGVHD that meets the NIH diagnostic criteria (031) for steroid dependence or resistance, meeting one of the following:
- There was no improvement in cGVHD in initial treatment patients treated with \> 0.5mg/kg/ day or 1 mg/kg/ day every other day for at least 4 weeks;
- Steroid dependence: predtisone dose \> 0.25 mg/kg/d or \> 0.5 mg/kg/qod cGVHD relapse or progression; cGVHD recurred after two attempts to gradually reduce prednisone dose at an interval of at least 8 weeks, with...
- Prednisone dose \> 0.25 mg/kg/d for more than 4 weeks; people must maintain a stable prednisone dose for 4 weeks prior to the first Treg cell infusion and not increase or discontinue other immunosuppressants (including...
- The ECOG score of the people was 0-2;
- the expected survival of the subject is more than 3 months;
- Liver, kidney, heart and lung function meet the following requirements (except liver and kidney dysfunction caused by cGVHD) :
- Creatinine clearance (calculated by Cockcroft Gault formula) ≥60 mL/min;
- Cardiac ejection fraction greater than 50%, no clinically significant electrocardiogram changes;
- Forced expiratory volume (FEV1) in the first second of baseline lung function ≥50%, and FEV1 decline caused by cGVHD could be included;
- Total bilirubin ≤2.0ULN; ALT and AST≤3ULN, ALT and AST increases caused by cGVHD could be included in the group.
- Hematopoietic function: neutrophils \>1×10\^9/L, platelets \>25×10\^9/L; Supportive treatments such as platelet transfusion and other cytokines are excluded.
- The subject or the subject's guardian can understand this experiment and has signed the informed consent.
- Donor age 14-70 years old, male or female;
- The ECOG score of the donor is 0-1;
- The donor must be a hematopoietic stem cell donor who underwent allo-HSCT prior to the subject;
- Female donors must test negative for serum or urine beta-human chorionic gonadotropin (HCG) within 3 weeks of blood collection;
- The donor can establish the necessary venous access for collection, without the contraindication of white blood cell collection; If peripheral venous leukocyte collection is insufficient, be willing to insert a central...
- people had a recurrence of primary malignant disease before receiving Treg treatment;
- The people had persistent, recurrent or delayed aGVHD;
- Continuous use of prednisone \>1 mg/kg/day is required;
- The severity of the subject's cGVHD cannot be assessed by physical examination or laboratory examination;
- overlap syndrome；
- The people had major organ (cardio-cerebrovascular, pulmonary) dysfunction not caused by cGVHD, and had previous (within 3 months) gastrointestinal active bleeding; History of uncontrolled hypertension or hypertensive...
- The people are hemodialysis patients;
- The subject or donor has an active, uncontrolled bacterial, viral, or fungal infection that requires treatment；
- The people are pregnant or lactating women; people who plan to become pregnant during the post-transfusion study, or within 1 year of completion or withdrawal from the study;
- Participants who had received IL-2 therapy or drug therapy targeting IL-2 within 4 weeks prior to enrollment；
- Received DLI treatment within 100 days before enrollment;
- Received CAR-T or similar engineered cell therapy within 100 days prior to enrollment;
- Had received new cGVHD therapies (including imatinib, BTK inhibitors, rituximab and other immunosuppressants) within 4 weeks before enrollment after transplantation;
- Have a history of microvascular diseases such as TMA, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, etc；
- people with poor IL-2 treatment compliance;
- Participants who participated in other CGVHD-related clinical studies within 4 weeks prior to enrollment;
- people who are known to be allergic to any component of Treg cell injection;
- Any situation that the investigator believes would compromise the safety of the subject or interfere with the study purpose, or that the investigator considers it inappropriate to participate in the study;
- Having a medical condition that affects the signing of written informed consent or the inability to follow study procedures; Unwilling or unable to comply with research requirements;
- The donor was a pregnant woman.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. 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.