RecruitingPhase 1NCT03802695

A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies


Sponsor

Orca Biosystems, Inc.

Enrollment

300 participants

Start Date

Apr 8, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.


Eligibility

Min Age: 12 YearsMax Age: 78 Years

Plain Language Summary

Simplified for easier understanding

This phase 1 trial is testing a new type of stem cell transplant product called Orca-Q for patients with blood cancers who need a stem cell transplant from a donor. Orca-Q is a specially engineered version of donor stem cells designed to reduce serious complications, particularly graft-versus-host disease (where donor immune cells attack the patient's body) while still fighting the cancer. **You may be eligible if...** - You are between 12 and 78 years old (age limits vary by treatment arm and donor match) - You have been diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype leukemia, or high-risk myelodysplastic syndrome (MDS) - Your disease is in remission or meets the specific disease criteria for the study arm - You have a suitable matched or partially matched donor **You may NOT be eligible if...** - You are outside the eligible age range for your specific treatment arm - Your leukemia is not in adequate remission - You have severe organ problems or active infections that make transplant unsafe - You do not have a suitable donor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOrcaGraft (Orca-Q)

engineered donor allograft


Locations(9)

City of Hope

Duarte, California, United States

UC Davis

Sacramento, California, United States

Stanford Health Care

Stanford, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

The University of Kansas Hospital

Kansas City, Kansas, United States

Ohio State University

Columbus, Ohio, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03802695


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