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CAR T-cell Therapy

Engineered Donor Grafts (Orca-T) for Blood Cancers

Phase 1
Waitlist Available
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]
Must not have
History of prior allogeneic HCT
Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stem cell transplant from a donor.
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I currently have an infection that isn't getting better with treatment.
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I am scheduled for a treatment that reduces T cells in my body.
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I have an autoimmune disease that is not under control and requires treatment.
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I am not pregnant or breastfeeding.
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I need assistance with my daily activities.
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I am scheduled for a donor lymphocyte infusion.
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I have antibodies against the donor's specific HLA type.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The incidence of grade 3 or 4 aGVHD
The incidence of primary graft failure
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Orca Biosystems, Inc.Lead Sponsor
6 Previous Clinical Trials
482 Total Patients Enrolled

Media Library

Orca-T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04013685 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Subjects with Acute Leukemia or Myelodysplasic Syndrome, or BPDCN
Myelodysplastic Syndrome 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
~42 spots leftby Dec 2025
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