Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)

Plain-language summary

This study examines a cell therapy called donor-derived MultiTAA-specific T cells in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). It includes patients who have undergone an allogeneic stem cell transplant and will receive these cells as adjuvant therapy or as treatment for relapsed/refractory disease. It is being conducted in Phase 1; it is currently not recruiting but is still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Baylor College of Medicine

Intervention

MultiTAA-specific T cells

Start date

2/1/2016

Estimated completion

2/1/2027

Countries

United States

Related genes

Locations

• Houston, United States
• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as;

   (i) Adjuvant therapy for AML/MDS (Group A) or

   (ii) Treatment for refractory/relapsed or minimal residual AML/MDS disease (Group B)

   Residual disease at the time of transplant or post transplant relapse is defined as PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy, in the peripheral blood or any other extramedullary sites.

   Minimal residual disease (MRD) will be defined as detection in blood, bone marrow, or other tissues of any of the following:

   (i) Any leukemia specific marker such as t(8;21); inv 16; t (15;17), t(9;22) or t(4;11) documented in the patient's leukemia cells pre-transplant on a post-transplant evaluation.

   (ii) Expression of a leukemia associated antigen known to be a marker for residual disease like WT1.

   (iii) A leukemia-specific phenotype (e.g. expression of markers including CD13 and/or CD33 and/or CD117 and/or HLA-DR+) post-transplant at a level of ≥ 0.01%.

   (ix) Mixed donor chimerism (\> 20%).
2. Life expectancy ≥ 6 weeks.
3. Karnofsky/Lansky score of ≥ 50.
4. Patient or parent/guardian capable of providing informed consent.
5. Bilirubin ≤ 2X upper limit of normal.
6. AST ≤ 3X upper limit of normal.
7. Undergoing stem cell transplant at CAGT.
8. Serum creatinine ≤ 2X upper limit of normal.
9. Hgb ≥ 7.0 g/dL (can be transfused).
10. Pulse oximetry of \> 90% on room air.
11. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion. Male partner should use a condom.
12. Available donor-derived multiTAA-specific T cell line.
13. No other investigational anti-neoplastic therapy for one month prior to entry in this study.

Exclusion Criteria:

1. Patients receiving ATG or Campath within 28 days of infusion.
2. Patients receiving a Donor Lymphocyte Infusion within 4 weeks of planned T cell infusion.
3. Less than 30 days post-allogeneic stem cell transplant.
4. Severe intercurrent infection.
5. Evidence of GVHD \> Grade II.
6. Pregnant or lactating.
7. Currently taking corticosteroids (\> 0.5 mg/kg/day prednisone or equivalent).