Clinical trial · Interventional
TCR Alpha/Beta and CD19-deplete Haplo-HSCT
TCR Alpha/Beta and CD19-depleted Allogeneic Hematopoietic Cell Transplant for Malignant and Non-Malignant Disease
NCT05288595CI-TRIAL-00081751withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Cancelled by Sponsor
Summary
Brief summary (as posted)
This is an open label, interventional, non-randomized, phase II trial of TCR alpha/beta and CD19-depeleted allogeneic HCT in pediatric patients with hematologic disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Other Hematologic Condition | — | UNRESOLVED | — |
| Pediatric Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS Plus Instrument | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pediatric patients with malignant or non-malignant hematologic condition
- description
- The infusion of the final TCRαβ/CD19 depleted product will be given through the recipient's central venous catheter and will be administered fresh, without cryopreservation whenever possible. If the product must be cryopreserved and then thawed, this will be done according to institutional standards.
- interventionNames
- Device: CliniMACS Plus Instrument
Primary outcomes (1)
- measure
- Incidence of severe (grade III-IV) acute graft-versus-host disease (GVHD) at day 100 after infusion of a TCRαβ+/CD19+ negative, peripheral blood stem cell (PBSC) product without additional GVHD prophylaxis.
- timeFrame
- 5 years
- description
- Grade to be determined using Acute GVHD Staging Scale
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 31 Days
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 31 days to \<30 years 2. Have a malignant or non-malignant hematologic disease, defined as disease resulting from abnormal function of a cell of the hematopoietic stem cell lineage, that could benefit from an allogeneic HCT. Examples include acute and chronic leukemias, myelodysplastic syndrome, lymphoma, severe acquired and congenital cytopenias/marrow failure, white blood cell abnormalities, red blood cell abnormalities, and platelet abnormalities. 3. Clinical remission for patients with acute leukemia (MDS/AML excluded) or lymphoma 4. Lack a healthy and willing HLA-identical related donor, with the exception of patients with FA who will be eligible with a willing HLA-identical related donor given the standard use of T-cell depletion in matched sibling donor HCT in FA 5. Have a related or an unrelated donor who meets the donor selection criteria, is healthy, willing, and able to receive GCSF with or without Plerixafor, and undergo apheresis through placement of catheters in the antecubital veins or a temporary central venous catheter 6. Able to give informed consent if ≥ 18 years, or with legal guardian capable of giving informed consent if \< 18 years 7. Provision of signed and dated informed consent form Exclusion Criteria: 1. Uncontrolled, active infection at time of HCT 2. HIV positivity 3. Cardiac ejection fraction \<45% 4. Creatinine clearance \<60 mL/min/1.72 mL 5. Pulmonary diffusion capacity (adjusted for hemoglobin), FEV1, or FVC \<60% of predicted or an O2 saturation \<94% on room air if unable to perform pulmonary function testing 6. Serum ALT \>5x upper limit of normal or bilirubin \>2 7. Performance score (Lansky or Karnofsky) \<50 8. Pregnant or lactating females, as many medications necessary for a successful HCT are potentially harmful to unborn babies and infants.
References
Publications (0)
Data not yet available
No reference posted for this study.