Orca-T for leukemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
leukemia+15 More
Orca-T - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the safety and efficacy of a new treatment (Orca-T) to the standard of care (SOC) for people undergoing a bone marrow transplant for blood cancer.

Eligible Conditions
  • leukemia
  • MDS
  • Mixed Phenotype Acute Leukemia (MPAL)
  • Leukemia, Myelocytic, Acute
  • Therapeutic procedure
  • High-risk Myelodysplastic Syndrome (MDS)
  • Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Day 0 through 730 days post-transplant

Day 365
Graft-versus-Host-Disease and Relapse-free survival (GRFS)
Moderate to severe chronic graft-versus-host-disease
Day 730
Relapse-free survival
Day 730
Chronic Graft-versus-Host-Disease-free Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Standard of Care alloHCT Control
1 of 2
Orca-T
1 of 2

Active Control

Experimental Treatment

174 Total Participants · 2 Treatment Groups

Primary Treatment: Orca-T · No Placebo Group · Phase 3

Orca-T
Biological
Experimental Group · 1 Intervention: Orca-T · Intervention Types: Biological
Standard of Care alloHCT Control
Biological
ActiveComparator Group · 1 Intervention: Standard-of-Care · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 0 through 730 days post-transplant

Who is running the clinical trial?

Orca Biosystems, Inc.Lead Sponsor
5 Previous Clinical Trials
450 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are an 8/8 match for HLA-A, -B, -C, and DRB1.
You are in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease.
You have a heart with normal ejection fraction or shortening fraction.
DLCO must be ≥ 50% of the predicted value.
You are of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.