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New treatment option for Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia...
Official title Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies
ClinicalTrials.gov ID: NCT02203903
What this study is testing
What is Tumor associated antigen lymphocytes (TAA-T)?
Tumor associated antigen lymphocytes (TAA-T) is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 80
You may be able to join if
- Recipient 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.
You likely can't join if
- 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
See the full eligibility criteria
- Recipient 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.