RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Months to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients with high risk for relapse will be eligible to receive planned infusion of allogeneic TAA-T after HSCT (with high risk AML and MDS who have undergone allo-HSCT and are in a hematologic remission)."
  • "Exploratory investigational analyses would include monitoring of cytokine and cellular milieu pre- and post- TAA-T infusion and in vitro characterization of the host tumor, donor lymphocyte product, and TAA-T product."
  • "Infusions will be within first 5 months post-HSCT."
  • "Each patient will receive at least one infusion according to the enrolled dose level, where the expected volume of infusion is 1 to 10 cc."
  • "A subsequent dose (infusion #2) will also be available for those patients who have stable disease or a mixed, partial, or complete response (including continued complete response) by the International Working Group (IWG) criteria (see section 4.2.1) at the evaluation after the first TAA-T infusion."
  • "Patients who have received at least 2 infusions of TAA-T are eligible to receive up to 6 additional doses (infusion #3 to #8) of TAA-T at monthly intervals each of which will consist of the same cell number as their enrolled dose level."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety of different doses of T cells, immune cells made to target cancer. It is for people with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), cancers of blood-forming cells, who have had or will have a stem cell transplant from a donor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be 6 months to 80 years old, with high-risk AML or MDS that has not returned in the blood after transplant.
  • Patients must have had or plan to have a donor stem cell transplant. The transplant must be done before they receive the study T cells.
  • Patients must score at least 50 on a scale of ability to do daily tasks. The patient or a parent or guardian must be able to give consent.
  • Patients must agree to use birth control during the study, when age appropriate.
  • Before treatment, patients must meet liver, kidney, oxygen, and infection-fighting blood cell test limits. Some patients who had whole-body radiation also need heart tests.
  • Before treatment, steroid doses must be below 0.5 mg/kg/day of prednisone or an equal dose, with no treatment increase in the past 2 weeks. Tests must also show enough donor cells.
  • Donors must be 6 months to 80 years old and meet transplant donor rules. The donor or a child's guardian must be able to give consent.
  • Donors need infection tests within 7 days before or after blood collection. Donors who could become pregnant need a negative pregnancy test within 7 days of collection.

Who can't join

  • Patients with infections that are not controlled cannot join or receive treatment.
  • Patients cannot join with graft-versus-host disease (GVHD) above grade 2. GVHD happens when donor cells attack the body.
  • Certain lung damage, skin-hardening GVHD, or inflammation around organs prevents joining; active forms also prevent treatment.
  • Patients in Arm C cannot receive treatment if they have active acute GVHD, or chronic GVHD needing more treatment in the past 2 weeks.
  • Patients cannot receive study T cells within 28 days of ATG, Campath, other antibodies that suppress T cells, or certain experimental treatments.
  • Patients who are pregnant cannot join or receive treatment. Breastfeeding patients cannot receive treatment.
  • Patients who have had or will have a second donor stem cell transplant cannot receive study T cells.
  • Donors cannot take part if they are pregnant or if giving cells could harm their physical or mental health.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Recipient Inclusion Criteria to Enter Protocol: * Aged 6 months to 80 years. * Anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant. * Patients with high risk AML and MDS who have received or will receive an allo-HSCT and have not had hematologic relapse of disease. * Karnofsky/Lansky score of ≥ 50. * Agree to use contraceptive measures during study protocol participation (when age appropriate). * Patient or parent/guardian capable of providing informed consent. * T cell chimerism \> 94% if collected from recipient of allo-HSCT Recipient Exclusion Criteria to Enter Protocol: * Patients with uncontrolled infections. * Current evidence of GVHD \> grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. * Pregnancy (female of childbearing potential). Recipient Inclusion Criteria for TAA-T Administration: * Patients with high risk AML and MDS who have received an allo-HSCT and have not had hematologic relapse of disease. * Steroids less than 0.5 mg/kg/day prednisone or equivalent in the context of no escalation of treatment within the preceding 2 weeks * Karnofsky/Lansky score of ≥ 50. * Bilirubin \< 2.5 mg/dL, AST/ALT \<5x upper limit of normal, Serum creatinine \< 1.0 or 2x the upper limit of normal (whichever is higher). * Pulse oximetry of \> 90% on room air. * Absolute neutrophil count \> 250/ µL (may be supported with Granulocyte colony-stimulating factor (GCSF)). * Agree to use contraceptive measures during study protocol participation (when age appropriate). * Patient or parent/guardian capable of providing informed consent. * LVEF \> 50% or LVSF \> 27% (performed within the last 6 months) if history of TBI \>500 cGy for arm A and B. * Total chimerism \> 50%; or if cancer cells preclude this, donor T cell chimerism \> 50% (performed within the last 6 months). Recipient Exclusion Criteria for TAA-T Administration: * Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T infusion. * No investigational therapies (under IND, not extensively studied in the current clinical context) within 28 days prior to TAA-T infusion. * Uncontrolled infections. * Active Bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. * Active acute GVHD or chronic GVHD requiring escalation of treatment within preceding 2 weeks of any grade is exclusion for Arm C patients. * Pregnancy or lactating (female of childbearing potential). * Patients who have or will be receiving 2nd allogeneic HSCT Donor Inclusion 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. Donor Exclusion Criteria: * Donation of cells would pose a physical or psychological risk to the donor. * Female donors of childbearing age who are known to be pregnant.

Study sites (2)

DC

MD