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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02519816

Acronym

CARE

Enrollment

Registered

2015-08-11

Start date

2016-03-31

Completion date

2020-01-01

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic GVHD After HCT for Cancer or Immune Disease

Keywords

post stem cell transplantation, Steroid refractory, dependent chronic

Brief 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)

Interventions

OTHERAutologous 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is failure-free survival (FFS) at 24 weeks	24 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026