Clinical trial · Interventional
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
NCT02203903CI-TRIAL-00122082RESOLVErecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor associated antigen lymphocytes (TAA-T) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor associated antigen lymphocytes (TAA-T)
- description
- TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first. All infusions will be within 5 months post-HSCT. Patients will receive a TAA-T cell dose of 4 x 107 cells/m2.
- interventionNames
- Biological: Tumor associated antigen lymphocytes (TAA-T)
Primary outcomes (4)
- measure
- Safety of investigational product (TAA-T)
- timeFrame
- 45 days
- description
- Acute GVHD grades III-IV within 45 days of the last dose of TAA-T
- measure
- Safety of TAA-T cells
- timeFrame
- 45 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKinoshita H, Cooke KR, Grant M, Stanojevic M, Cruz CR, Keller M, Fortiz MF, Hoq F, Lang H, Barrett AJ, Liang H, Tanna J, Zhang N, Shibli A, Datar A, Fulton K, Kukadiya D, Zhang A, Williams KM, Dave H, Dome JS, Jacobsohn D, Hanley PJ, Jones RJ, Bollard CM. Outcome of donor-derived TAA-T cell therapy in patients with high-risk or relapsed acute leukemia post allogeneic BMT. Blood Adv. 2022 Apr 26;6(8):2520-2534. doi: 10.1182/bloodadvances.2021006831. PMID 35244681