Treatment of Refractory cGVHD by Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2

ConditioncGVHD
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

Subjects aged 18-70 years old, male or female;

The subjects had received allo-HSCT, including cord blood transplantation;

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/day to be maintained.

Disqualifiers

Subjects had a recurrence of primary malignant disease before receiving Treg treatment;

The subjects 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;

Trial design

Treatments tested in this trial

  • Donor-derived Treg cell injection combined with interleukin 2

Treatment groups

18 Participants
are divided into 1 treatment group