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Cancer Vaccine

TRX103 for Blood Cancers

Phase 1
Recruiting
Research Sponsored by Tr1X, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight of ≥ 35 Kg
Subjects with Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
Must not have
Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
History of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety of TRX-103 in patients with blood cancers who are undergoing a stem cell transplant. They plan to enroll up to 36 patients over 18-24 months

Who is the study for?
This trial is for people with various blood cancers like leukemia who are undergoing a stem cell transplant from a donor that doesn't fully match their tissue type. They're testing if TRX-103 can prevent a common and serious complication called Graft-versus-Host Disease.
What is being tested?
The study is looking at the safety of TRX-103 when given once after a mismatched stem cell transplant. It's an early-phase trial, meaning it's one of the first times this drug is being tested in humans to see how well they tolerate it.
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety, specific side effects of TRX-103 aren't listed yet. Generally, such trials monitor for any unexpected reactions ranging from mild symptoms to more severe complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 35 Kg.
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I have been diagnosed with a specific type of blood cancer.
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I am mostly able to care for myself.
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I do not have any ongoing serious infections.
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I have a donor for a stem cell transplant that is not a perfect match.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bone marrow or stem cell transplant from a donor.
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I have a history of major organ dysfunction or am on treatment for heart issues.
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I have had TTP or HUS and cannot be treated with sirolimus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: TRX-103Experimental Treatment1 Intervention
TRX-103 will be infused on time post hematopoietic stem cell transplant (HSCT).

Find a Location

Who is running the clinical trial?

Tr1X, Inc.Lead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
Maria Grazia Roncarolo, MDStudy DirectorTr1X, Inc.
1 Previous Clinical Trials
30 Total Patients Enrolled
~22 spots leftby Apr 2026
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