NCT02203903 Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies
| NCT ID | NCT02203903 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Catherine Bollard |
| Condition | Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2015-01-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2015-01-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02203903 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 80 Years, studying Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02203903 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02203903 currently recruiting?
Yes, NCT02203903 is actively recruiting participants. Contact the research team at fhoq@childrensnational.org for enrollment information.
Where is the NCT02203903 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States.
Who is sponsoring the NCT02203903 clinical trial?
NCT02203903 is sponsored by Catherine Bollard. The trial plans to enroll 50 participants.
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