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CAR T-cell Therapy

OrcaGraft for Blood Cancer

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
Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor
Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days after administration of orca-q/orcagraft
Awards & highlights

Study Summary

This trial will test a new type of transplant to treat blood cancer. It will measure safety, effectiveness, and how well it's tolerated.

Who is the study for?
This trial is for adults aged 18-65 with certain blood cancers like acute leukemia or high-risk myelodysplastic syndrome. Participants must match with a donor, have good kidney and heart function, and not be pregnant or on strong immunosuppressants. Those with uncontrolled infections, other active cancers, prior transplants, or severe comorbidities cannot join.Check my eligibility
What is being tested?
The study tests 'OrcaGraft' (Orca-Q), an engineered donor graft in patients receiving bone marrow transplants for blood cancers. It aims to assess the safety and effectiveness of this new treatment approach during the transplant process.See study design
What are the potential side effects?
While specific side effects are not listed here, similar procedures can include risks such as immune reactions against the graft (graft-versus-host disease), infections due to weakened immunity from transplantation, organ damage related to chemotherapy used before transplanting cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a donor who is a close genetic match for my transplant.
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I am scheduled for a stem cell transplant from a donor.
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I have been diagnosed with a specific type of blood cancer or a high-risk bone marrow disorder.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after administration of orca-q/orcagraft
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days after administration of orca-q/orcagraft for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Dose Limiting Toxicities
Primary Graft failure through Day +28 (dose expansion)
Secondary outcome measures
Acute GVHD through Day +100
Chronic GVHD through Day +365
Disease-free survival (DFS) through Day +365
+10 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment1 Intervention
Recipients with an HLA-identical related or unrelated donor; no GVHD prophylaxis given
Group II: Arm BExperimental Treatment1 Intervention
Recipients with haploidentical-related donors; with single-agent GVHD prophylaxis given
Group III: Arm AExperimental Treatment1 Intervention
Recipients with HLA-identical or 1-allele mismatched (7/8 alleles) related or unrelated donor; with single-agent GVHD prophylaxis given

Find a Location

Who is running the clinical trial?

Orca Biosystems, Inc.Lead Sponsor
5 Previous Clinical Trials
527 Total Patients Enrolled
James S McClellan, MD, PhDStudy DirectorOrca Biosystems, Inc.

Media Library

OrcaGraft (Orca-Q) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03802695 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Arm C, Arm B, Arm A
Acute Myeloid Leukemia Clinical Trial 2023: OrcaGraft (Orca-Q) Highlights & Side Effects. Trial Name: NCT03802695 — Phase 1
OrcaGraft (Orca-Q) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03802695 — Phase 1

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Stanford Health Care
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
2019. "A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03802695.
All > Mds > Myelodysplastic Syndrome
~52 spots leftby Apr 2026
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