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CAR T-cell Therapy

Engineered Donor Grafts (Orca-T) for Blood Cancers

Phase 1

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

Blastic Plasmacytoid Dendritic Cell Neoplasm [Ages 18-65]

Patients must be diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned: acute myeloid, lymphoid or mixed phenotype leukemia that is not in CR/CRi [Ages 18-65]

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

Study Summary

This trial will test a new type of transplant that may be safer and more effective than the current standard.

Who is the study for?

This trial is for adults with certain blood cancers like acute leukemia or myelodysplastic syndrome who need a stem cell transplant. They must be relatively healthy, with good liver, kidney, heart and lung function, not have other active cancers or serious infections, and can't be pregnant or breastfeeding. Participants should match an 8/8 HLA donor and cannot have had a previous transplant.Check my eligibility

What is being tested?

The study tests 'Orca-T', an engineered donor graft designed to improve outcomes in patients receiving bone marrow transplants for various hematologic malignancies. It aims to see if this new method is safe and works well compared to traditional approaches.See study design

What are the potential side effects?

Potential side effects may include typical risks associated with stem cell transplantation such as infection risk due to immune system suppression, graft-versus-host disease where the donated cells attack the body's own tissues, and complications from organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old with a diagnosis of Blastic Plasmacytoid Dendritic Cell Neoplasm.

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I am 18-65 with a certain type of leukemia and plan to have a stem cell transplant.

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I am 18-65 with high-risk leukemia in remission.

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I have a donor who is a perfect match for my bone marrow transplant.

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I am 66-75 with high-risk leukemia or MDS in remission.

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I am between 18 and 65 years old with myelofibrosis.

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I am aged 18-65 with a specific bone marrow condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The incidence of grade 3 or 4 aGVHD

The incidence of primary graft failure

Secondary outcome measures

1 year graft-versus-host-disease-free and relapse-free survival (GRFS)

1-year overall survival (OS)

incidence and severity of acute and chronic graft vs host disease (GvHD)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with Acute Leukemia or Myelodysplasic Syndrome, or BPDCNExperimental Treatment1 Intervention

This is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Orca Biosystems, Inc.Lead Sponsor

5 Previous Clinical Trials

458 Total Patients Enrolled

5 Trials studying Leukemia

458 Patients Enrolled for Leukemia

Media Library

Orca-T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04013685 — Phase 1

Leukemia Research Study Groups: Subjects with Acute Leukemia or Myelodysplasic Syndrome, or BPDCN

Leukemia Clinical Trial 2023: Orca-T Highlights & Side Effects. Trial Name: NCT04013685 — Phase 1

Orca-T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04013685 — Phase 1

Frequently Asked Questions

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

Are applicants over the age of 45 being considered for participation in this research?

"The recruitment criteria for this trial require that prospective participants are at least 18 years of age and not yet 75."

Answered by AI

Is enrollment still available for this research endeavor?

"Affirmative. The public-facing clinicaltrials.gov page states that this investigation is still open for recruitment of participants, with the initial post having been published on November 21st 2019 and last updated October 18th 2022. This trial requires 255 patients to be enrolled from 14 different sites."

Answered by AI

What are the risk profiles associated with TregGraft (Orca-T) treatment?

"Considering the limited data on safety and efficacy, our team at Power has assigned TregGraft (Orca-T) a score of 1."

Answered by AI

How many sites are involved in carrying out this experiment?

"14 sites are currently enrolling for this trial, including University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center in Miami, Weill Cornell Medicine - New york-Presbyterian Hospital in New York, and Winship Cancer Institute - Emory University in Atlanta. Other locations may also be available."

Answered by AI

Do any particular demographics make for ideal study candidates in this trial?

"This clinical trial, which is recruiting 255 participants between 18-75 years of age that have myelodysplastic syndromes (MDS), has particular criteria for enrolment. These include having acute myeloid, lymphoid or mixed phenotype leukemia that isn't in CR/CRi (Ages 18-65); being categorized as DRI very high risk with the same condition(Ages 18-65); Myelofibrosis sufferers(18-65) and Blastic Plasmacytoid Dendritic Cell Neoplasms patients (18- 65). Furthermore, those aged 66 to 75 must possess"

Answered by AI

How many participants have been selected to take part in this trial?

"To satisfy the study's requirements, 255 participants who meet the stated inclusion criteria must enroll. These individuals can seek enrollment in medical facilities such as University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center located in Florida, or Weill Cornell Medicine - New york-Presbyterian Hospital found in Georgia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

2019. "Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04013685.

All > Mds > Myelodysplastic Syndrome