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

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05643638
Protocol IDs
CYP-GvHD-P2-01 (primary)
NCI-2023-07137
Study Sponsor
Cynata Therapeutics Limited

Summary

This study is a prospective randomized placebo-controlled phase 2 study to compare
CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell
transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and
throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC)
guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on
Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as
appropriate per institutional guidelines. Subjects will have study visits up to Day 100
during the Primary Evaluation Period. During the Follow-Up Period, subjects will have
study visits up to 24 months.

Eligibility

  1. Undergone allogeneic hematopoietic stem cell transplant (HSCT)
  2. Clinically diagnosed with acute GvHD requiring systemic therapy with corticosteroids.
  3. 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
  4. Evidence of myeloid engraftment post allogeneic HSCT
  5. Life expectancy of at least one month

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.