A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD

Overview

About this study

The purpose of this study is to evaluate the effectiveness of CYP-001 and CS vs placebo and CS in adults with HR-aGvHD based on Overall Response Rate (ORR) at Day 28.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Undergone allogeneic hematopoietic stem cell transplant (HSCT)

- Clinically diagnosed with acute GvHD requiring systemic therapy with corticosteroids.

- HR-aGvHD must meet one of the following clinical features within 72 hours prior to
randomization: (a) high-risk as per Refined Minnesota Criteria; OR (b) One of the
following: (i) isolated stage 2 involvement of the lower GI tract; (ii) Stage 1 lower
GI tract disease with skin involvement

- Evidence of myeloid engraftment post allogeneic HSCT

- Life expectancy of at least one month

Exclusion Criteria:

- Received any systemic treatment for aGvHD other than corticosteroids +/- calcineurin
inhibitors

- Chronic GvHD or overlap syndrome with both acute and chronic features of GvHD

- Relapsed primary malignancy since

- received more than one allogeneic HSCT

- Clinically significant respiratory, renal or cardiac disease

- Cholestatic disorders or sinusoidal obstructive syndrome/veno-occlusive disease of the
liver

- Any active uncontrolled infection requiring treatment and likely to impact on the
ability of the subject to participate in the trial.

- Known infection with CMV, EBV, HHV-6, HBV, HCV, HIV or Tuberculosis. If the treatment
for CMV, EBV, HHV-6, HBV, HCV has commenced the subject is eligible.

- Known sensitivity to dimethylsulfoxide (DMSO) or any other component of CYP-001.

- Received any investigational treatment agent within 30 days or within 5 half-lives of
Screening, whichever is greater.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Saurabh Chhabra, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hemant Murthy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available