RECRUITING

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

Description

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.

Conditions

Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS
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Related Conditions:

Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS
Intervention / Treatment

-

Contacts and Locations

Washington

Childrens National Medical Center, Washington, District of Columbia, United States, 20010

Baltimore

Tania Jain, MD, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have undergone eligibility evaluation as per FDA regulations outlined in 21 CFR 1271 subpart C. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for TAA-T generation provided that there are no new reasons for ineligibility since the transplant donor evaluation.
  • * Aged 6 months to 80 years.
  • * Donor or guardian of pediatric capable of providing informed consent.
  • * Donor must have completed infectious Disease (ID) testing up to 7 days before or after the collection of blood from the donor (related or unrelated) for TAA-T manufacturing. The following tests will be performed:
  • * HBsAg
  • * HB Core antibody
  • * HIV1/2 NAT
  • * Syphilis (T. Pallidum IgG)
  • * HTLV I/II
  • * CMV total
  • * HBV/HCV NAT
  • * West Nile Virus NAT.
  • * Cruz (Chagas) antibody
  • * Hepatitis C
  • * Female donors of childbearing age must have a negative pregnancy test within 7 days of blood collection for TAA-T manufacturing.
  • * Donation of cells would pose a physical or psychological risk to the donor.
  • * Female donors of childbearing age who are known to be pregnant.

Ages Eligible for Study

6 Months to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Catherine Bollard,

Study Record Dates

2027-06-28