Clinical trial · Interventional
Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies
Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients
- 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 trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. Removing the T cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.
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 |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aldesleukin | Biological | Aldesleukin | ALIAS |
| Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion | Procedure | — | UNRESOLVED |
| Umbilical Cord Blood-Derived Lymphocyte Therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (T-cell infusion)
- description
- Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
- interventionNames
- Biological: Aldesleukin
- Procedure: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
- Biological: Umbilical Cord Blood-Derived Lymphocyte Therapy
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of ex vivo expanded T-cells defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30%
- timeFrame
- Up to day 45
- description
- Dose limiting toxicity is defined as grade IV graft-versus-host disease (GVHD), grades 3-4 acute GVHD occurring within 45 days of the study T cell infusion, grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic), grade 4 cytopenia, or any grade 4 or 5 organ based (non-hematologic) toxicity.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: * Umbilical cord blood (UCB) recipients with underlying hematological malignancies presenting with post-transplant relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant * UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant * Performance score of at least 80% by Karnofsky or performance status (PS) \< 3 (Eastern Cooperative Oncology Group \[ECOG\]) (age \>= 12 years), or Lansky Play-performance scale of at least 60% or greater (age \< 12 years) * Negative beta human chorionic gonadotropin (HCG) or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study * Patient or patient's legal representative, parent(s) or guardian able to sign informed consent Exclusion Criteria: * Human immunodeficiency virus (HIV) positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant) * Patients with active (untreated) central nervous system (CNS) disease * Any active GVHD * Active invasive infections * Pregnant or breast-feeding
References
Publications (0)
Data not yet available