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CAR T-cell Therapy

ORCA-T for Blood Cancers

Phase 1

Waitlist Available

Research Sponsored by Lori Muffly

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 and ≤ 70 years at the time of enrollment

Eligible for myeloablative alloHCT with specific conditioning regimens

Must not have

Uncontrolled bacterial, viral, or fungal infections at time of enrollment

Prior allogeneic HCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine how safe it is to use Orca-T in combination with two drugs to prevent graft-versus-host disease.

Who is the study for?

This trial is for patients with advanced blood cancers like various types of leukemia and myelodysplastic syndrome, who are planning to undergo allogeneic hematopoietic cell transplantation (HCT). Specific eligibility criteria details were not provided.

What is being tested?

The trial is testing the safety of a new treatment called ORCA-T when used alongside two other drugs meant to prevent graft-versus-host disease (GVHD) after an allogeneic HCT.

What are the potential side effects?

Specific side effects were not detailed, but generally, treatments like ORCA-T could cause immune reactions, infection risk increase, or complications related to bone marrow transplant.

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 70 years old.

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

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My kidney function is normal or only mildly reduced.

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I have a donor who mostly matches my tissue type for a transplant.

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My leukemia is in remission or I have MDS suitable for a stem cell transplant.

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I am mostly able to care for myself but may need help.

Exclusion Criteria

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

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I do not have any ongoing serious infections.

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I have had a stem cell transplant from a donor.

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I am on corticosteroids or other immunosuppressive drugs.

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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 have antibodies against the donor's tissue.

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I am on medication for an autoimmune disease that is not under control.

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I have not been diagnosed with any cancer other than non-melanoma skin cancer in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of Patients Without Severe Transplant-Related Adverse Events at Day +100

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: ORCA-T + (tacrolimus and ruxolitinib)Experimental Treatment1 Intervention

Dual-agent tacrolimus starting on the day after Tcon infusion (Day +3 or Day +4) and ruxolitinib starting on the day after tacrolimus (Day +4 or Day +5).

0 / 14Eligibility criteria met