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CAR T-cell Therapy

Orca-Q for Pediatric Leukemia

Phase 1 & 2

Recruiting

Led By Biljana Horn, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of extramedullary disease

Age ≥ 18 and ≤ 50 years at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new type of transplant in children with blood cancer.

Who is the study for?

This trial is for children and young adults under 22 years old diagnosed with various types of leukemia, who are in remission but need a stem cell transplant. They must have good organ function, no active infections like COVID-19 or hepatitis, and not be on immunosuppressive drugs. Donors between 18-50 years old must match the patient's criteria and agree to donate stem cells.Check my eligibility

What is being tested?

The trial tests Orca-Q, an engineered donor graft for pediatric patients needing hematopoietic cell transplants. It aims to determine how safe and effective this treatment is when used in children with blood cancers that require a bone marrow transplant.See study design

What are the potential side effects?

While specific side effects of Orca-Q aren't listed here, similar treatments often involve risks such as immune reactions against the new cells (graft-versus-host disease), infections due to weakened immunity post-transplant, bleeding complications, and potential damage to organs.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has not spread outside the bone marrow.

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I am between 18 and 50 years old.

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I was diagnosed with cancer before turning 22.

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I am scheduled for a bone marrow transplant with intensive preparation.

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I am eligible for treatment at a center specializing in pediatric bone marrow transplants.

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My heart pumps well, with an ejection fraction of 50% or higher.

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I am willing to donate stem cells for two days in a row.

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I will use approved birth control methods during and for a year after the study.

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My leukemia is in complete remission or nearly so.

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I am using birth control to prevent pregnancy during and for a year after the study.

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I do not have more than one active cancer.

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My kidney function tests are within the normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Primary graft failure

Secondary graft failure

Secondary outcome measures

Graft-versus-host disease (GVHD)-free, relapse-free survival

Non-relapse mortality (12 months post-transplant)

Non-relapse mortality (24 months post-transplant)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Orca-QExperimental Treatment1 Intervention

0 / 12Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of FloridaLead Sponsor

1,343 Previous Clinical Trials

716,386 Total Patients Enrolled

Orca Biosystems, Inc.Industry Sponsor

5 Previous Clinical Trials

673 Total Patients Enrolled

Florida Department of HealthOTHER_GOV

28 Previous Clinical Trials

12,963 Total Patients Enrolled

Frequently Asked Questions

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

What are the main goals that researchers hope to achieve with this trial?

"The sponsor of this clinical trial, Orca Biosystems, Inc., has stated that the primary outcome will be determined over a 28 day period and is Secondary graft failure. Additionally, this trial will also assess more general outcomes like Overall survival and GVHD-free, relapse-free survival."

Answered by AI

Are there any current openings for this research project?

"The clinical trial is still recruiting patients, as seen on the website clinicaltrials.gov. The trial was first posted on 8/8/2022 and has been updated as recently as 8/26/2022."

Answered by AI

How many people have signed up to participate in this experiment?

"Yes, this is an active trial seeking 40 participants at a single site, as reflected in the most recent update to the listing on clinicaltrials.gov (8/26/2022). The listing was originally posted on 8/8/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)

2022. "Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322850.