RecruitingPhase 1NCT02203903

Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies

Multi-institutional Prospective Phase I Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies


Sponsor

Catherine Bollard

Enrollment

50 participants

Start Date

Jan 1, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.


Eligibility

Min Age: 6 MonthsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a type of immune cell therapy called TAA-T (Tumor-Associated Antigen T cells) — specially trained immune cells grown from the patient's stem cell donor — to prevent leukemia (AML and MDS) from coming back after a stem cell transplant. **You may be eligible if...** - You are between 6 months and 80 years old - You have high-risk AML or MDS and have received, or are planning to receive, a stem cell transplant from a donor - Your cancer has not relapsed after the transplant - Your general health is acceptable (Karnofsky/Lansky score at least 50) - You are willing to use contraception during the study (if age-appropriate) **You may NOT be eligible if...** - You have an uncontrolled active infection - You have significant graft-versus-host disease (a complication where the transplanted cells attack your body) - You are pregnant - Your organ function does not meet the minimum requirements at the time of cell infusion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTumor associated antigen lymphocytes (TAA-T)

TAA-T may be generated from donors or recipients and will be tested for specificity to 3 tumor antigens commonly found in hematological malignancies (WT1, PRAME, and SURVIVIN,). The goal of this cell infusion will be to initiate an immune response to residual leukemia or lymphoma that includes multiple antigens and may prevent tumor evasion (through decreased expression of a single antigen).


Locations(2)

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Tania Jain, MD

Baltimore, Maryland, United States

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NCT02203903