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CAR T-cell Therapy

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

Phase 3

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

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

Must not have

Karnofsky performance score < 70%

Prior allogeneic HCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 730 days after end of enrollment

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have MDS suitable for a stem cell transplant with less than 10% cancer cells in my bone marrow.

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My disease is classified as intermediate or high risk.

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I have a donor who perfectly matches my HLA type.

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I am scheduled for a specific type of bone marrow transplant.

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My leukemia is in remission, possibly with some remaining signs of disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need assistance with my daily activities.

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I have had a stem cell transplant from a donor.

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I am scheduled for a donor lymphocyte infusion.

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I am scheduled for a treatment that reduces T cells in my body.

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I am not pregnant or breastfeeding.

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I do not have any ongoing serious infections.

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I have tested positive for HIV, HTLV, or Hepatitis B/C.

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I am on active treatment for an uncontrolled autoimmune disease.

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My body has developed antibodies against the donor's tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 730 days after end of enrollment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chronic Graft-versus-Host-Disease-free Survival

Secondary study objectives

Graft-versus-Host Disease and Relapse-free survival (GRFS) up to 1 year

Overall Survival

Time to moderate or severe cGVHD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 14Eligibility criteria met