Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD

NCT02519816 — Phase 2, Unknown, 17 participants, daphne brockington

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Registry	NCT02519816, acronym CARE
Status	Unknown
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	17 (Actual)
Sponsor	daphne brockington (Other)
Conditions	Chronic GVHD After HCT for Cancer or Immune Disease
Interventions	Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte. (Other)
Dates	start 2016-03-01, primary completion 2020-01-01 (estimated), completion 2020-01-01 (estimated), first posted 2015-08-11, last updated 2019-08-14
Locations	1 site in Canada

-Summary

Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease.

Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Experimental	Other: Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.	Open-label phase II study. After signing informed consent, patients will undergo 6 times an apheresis during the 6-month treatment period. These cells will be manufactured into the Rhitol and frozen in aliquots. Then re-infused.

Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte. (Other)

+Outcome measures

Primary outcomes

The primary endpoint is failure-free survival (FFS) at 24 weeks [24 weeks]

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria: (Main)

* 1\. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.

AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):

* Progression on prednisone 7 mg/kg/week for 2 weeks, or
* Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
* Inability to taper prednisone below 3.5 mg/kg/week.

Exclusion Criteria: (Main)

* 1\. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.

OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.

OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.

OR 4. Time from allogeneic transplantation > 2 years. OR 5. Lymphocyte count < 0.2 x 109/L on two last consecutive CBCs before inclusion

+Locations (1)

Facility	City	Country	Status
Hospital Maissoneuve	Montreal, Quebec	Canada