← Back to Search

CAR T-cell Therapy

Orca-T for Blood Cancers (Orca-T Trial)

Phase 3
Recruiting
Research Sponsored by Orca Biosystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with myelodysplastic syndromes (MDS) indicated for alloHSCT per 2017 International Expert Panel recommendations and/or have therapy-related/secondary MDS, with ≤ 10% blast burden in the bone marrow
Disease Risk Index (DRI) overall risk categorization of intermediate or high
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 730 days after end of enrollment
Awards & highlights

Orca-T Trial 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.

Who is the study for?
This trial is for people with certain blood cancers or pre-leukemia who are in remission, have a matched donor for stem cell transplant, and whose major organs function well. They must not be pregnant, breastfeeding, or unwilling to use birth control. People with recent other cancers, prior transplants, severe infections or certain viruses like HIV can't join.Check my eligibility
What is being tested?
The study compares Orca-T (an engineered graft of T cells) versus standard care in patients undergoing myeloablative allogeneic hematopoietic cell transplantation for blood cancers. It aims to assess the safety and effectiveness of this new treatment approach.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar treatments often involve risks such as infection risk due to immune system suppression, reactions at infusion sites, potential organ inflammation from immune responses and general discomforts like fatigue.

Orca-T Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have MDS suitable for a stem cell transplant with less than 10% cancer cells in my bone marrow.
Select...
My disease is classified as intermediate or high risk.
Select...
I have a donor who perfectly matches my HLA type.
Select...
I am scheduled for a specific type of bone marrow transplant.
Select...
My leukemia is in remission, possibly with some remaining signs of disease.

Orca-T Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~730 days after end of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 730 days after end of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chronic Graft-versus-Host-Disease-free Survival
Secondary outcome measures
Graft-versus-Host Disease and Relapse-free survival (GRFS) up to 1 year
Overall Survival
Time to moderate or severe cGVHD

Orca-T Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Orca-TExperimental Treatment1 Intervention
For patients randomized to the Orca-T arm, Orca-T will be administered after myeloablative conditioning regimen. Single-agent GVHD prophylaxis with tacrolimus will be administered following Tcon infusion (generally Day +3).
Group II: Standard of Care alloHCT ControlActive Control1 Intervention
For patients randomized to the standard-of-care control arm, an unmanipulated allograft derived from the peripheral blood of a matched donor will be administered after a myeloablative conditioning regimen. Dual-agent prophylaxis consisting of tacrolimus plus methotrexate will be administered starting on Day -3.

Find a Location

Who is running the clinical trial?

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

Media Library

Orca-T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05316701 — Phase 3
Acute Leukemia Research Study Groups: Standard of Care alloHCT Control, Orca-T
Acute Leukemia Clinical Trial 2023: Orca-T Highlights & Side Effects. Trial Name: NCT05316701 — Phase 3
Orca-T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05316701 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many hospitals in North America are participating in this research project?

"This clinical trial is based in Methodist Hospital - Texas Transplant Institute in San Antonio, Texas, University of Chicago in Chicago, Illinois, and Moffitt Cancer Center in Tampa, Florida with other participating sites located throughout the country."

Answered by AI

Are there any entrance requirements for this trial?

"Eligibility for this trial requires that potential participants be between 18-65 years old, have been diagnosed with leukemia, and meet the following additional requirements: Be a HLA-A, -B, -C, and DRB1 8/8 match, in complete remission or CR with incomplete hematologic recovery (CRi) for acute myeloid, lymphoid or mixed phenotype leukemia, with or without the presence of known minimal residual disease, Myelodysplastic syndromes (MDS) that are indicated for alloHSCT per 2017 International Expert Panel recommendations and/or have therapy-related/secondary"

Answered by AI

Has the FDA cleared Orca-T for patient use?

"Orca-T's safety is rated 3 out of 3 because it is a Phase 3 trial, meaning that, while still in testing, there is strong evidence to support both its efficacy and safety."

Answered by AI

Can patients join the clinical trial at this time?

"The most recent information available on clinicaltrials.gov indicates that this study is still actively looking for participants. The clinical trial was first posted on 6/21/2022 and was most recently updated on 10/18/2022. A total of 174 patients are needed for the study, which will be conducted at 14 different locations."

Answered by AI

Do you think that the elderly would be good candidates for this type of research?

"The age limit for this trial is 65 years old. Anyone who is older than 18 years old can participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
2022. "Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05316701.
~58 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top