Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD
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|ClinicalTrials.gov Identifier: NCT02406651|
Recruitment Status : Recruiting
First Posted : April 2, 2015
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute GVH Disease||Drug: Recombinant Human Interleukin-22 IgG2-Fc (F-652) Drug: Systemic Corticosteroids||Phase 1 Phase 2|
This is a Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of F-652 in combination with systemic corticosteroids in subjects who have undergone HSCT and have newly diagnosed grade II-IV lower GI aGVHD. The HSCT may be derived from bone marrow, peripheral blood stem cells, or cord blood. The PK of F-652 in this subject population will be investigated. Subjects may be replaced if subject withdrawal is not related to safety or treatment response.
F-652 will be administered in conjunction with prednisone (or equivalent) at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD. Prednisone (or equivalent) will be given at a dose of 2 mg/kg/day and tapered as per protocol.
F-652 will be administered intravenously at a rate of 100 mL/hour for one hour once per week for four weeks. A total of 4 doses will be administered at a dose of 45 μg/kg each. Subjects will be followed for safety and efficacy through Day 180, and subject survival status will be collected at Day 365.
In the first stage of the trial, a total of 16 subjects will be enrolled. If six or fewer have a Day 28 treatment response, the trial will close due to a lack of efficacy. If seven or more have a response, an additional 11 subjects will be enrolled into study for a total sample size of 27. During the course of a subject's therapy, dose reduction may occur on an individual basis as per protocol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIa Study of Recombinant Human Interleukin-22 IgG2-Fc (F 652) in Combination With Systemic Corticosteroids for the Treatment of Newly Diagnosed Grade II-IV Lower Gastrointestinal Acute Graft-versus-Host Disease (aGVHD) in Hematopoietic Stem Cell Transplantation Recipients (HSCT)|
|Actual Study Start Date :||May 12, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: F-652 and systemic coritcosteroids
Subjects will be dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing will be concurrent with systemic corticosteroids.
Drug: Recombinant Human Interleukin-22 IgG2-Fc (F-652)
IV infusion of reconstitution lyophilized F-652.
Other Name: IL-22
Drug: Systemic Corticosteroids
Prednisone (or equivalent) at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) will be given at a dose of 2 mg/kg/day and tapered as needed.
- Number of Adverse events of F-652 in lower GI aGVHD subjects [ Time Frame: 28 days after first treatment of F-652 ]Determined by the number of AEs reported
- Number of subjects in treatment response for subjects with lower GI aGVHD [ Time Frame: Day 28 after first treatment of F-652 ]assessment of lower GI GVHD response rate to treatment of subjects with F-652
- Lower GI aGVHD response [ Time Frame: Measured at day 14 and 56 after initial dosing of F-652 ]Categorized by complete response (CR), partial response (PR), no response (NR), and progression.
- Overall GVHD response [ Time Frame: Measured at day 14, 28 and 56 after initial dosing of F-652 ]Categorized by complete response (CR), partial response (PR), no response (NR), and progression.
- Discontinuation of immunosuppressive medication [ Time Frame: Measured at Day 180 and 1 year after initial dosing of F-652. ]Number of days and subject with discontinuation of immunosuppressive medication
- Overall survival of subjects [ Time Frame: Measured 1 year after first infusion. ]Number of subjects with survival after 365 days of initial treatment dosing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406651
|Contact: Tom Tang, M.D.||(908) firstname.lastname@example.org|
|United States, New York|
|New York, New York, United States, 10065|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Tom Tang, M.D.||Generon (Shanghai) Corporation Ltd.|