Clinical trial · Interventional
Evaluating the Use of RFT5-dgA to Deplete Alloreactive Cells Prior to Haploidentical Stem Cell Transplantation
A Phase I Trial Evaluating The Use of RFT5-dgA to Deplete Alloreactive Cells PriorTo Haploidentical Stem Cell Transplantation
- 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 study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GVHD of \< / = 25%, to analyze immune reconstitution in these patients, and to measure their overall and disease free survival, at 100 days and at 1 year.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T-Cell Infusion Dose Level -1 | Biological | — | UNRESOLVED |
| T-Cell Infusion Dose Level 2 | Biological | — | UNRESOLVED |
| T-Cell Infusion Dose Level 3 | Biological | — | UNRESOLVED |
| T-Cell Infusion- Dose Level 4 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- After patients have completed preparation to receive cells, they will be treated at one of five dose levels.
- interventionNames
- Biological: T-Cell Infusion Dose Level -1
- Biological: T-Cell Infusion Dose Level 1
- Biological: T-Cell Infusion Dose Level 2
- Biological: T-Cell Infusion Dose Level 3
- Biological: T-Cell Infusion- Dose Level 4
Primary outcomes (1)
- measure
- Determining the number of donor lymphocytes given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin.
- timeFrame
- 100
Secondary outcomes (1)
- measure
- To measure their overall and disease free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease. * Myelodysplastic syndrome. * AML after first relapse or with primary refractory disease. * CML hemophagocytic lymphohistiocytosis (HLH) * Familial hemophagocytic lymphohistiocytosis (FLH) * Viral-associated hemophagocytic syndrome (VAHS) * X-linked lymphoproliferative disease (XLP) * Patients with Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy * Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor. * Donor cells should be collected and frozen before conditioning starts. Exclusion Criteria: * Patients with a life expectancy (\< or = to 6 weeks) limited by diseases other than leukemia. * Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e. shortening fraction \< 25%) * Patients with severe renal disease (i.e. creatinine clearance less than 40cc/1.73m2) * Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted) * Patients with severe hepatic disease (direct bilirubin greater than 3ug/dl or SGPT greater than 500ug/dl) * Patients with severe personality disorder or mental illness that would preclude compliance with the study * Patients with a severe infection that on evaluation by the Principal Investigator precluded ablative chemotherapy or successful transplantation * Patients with documented HIV positivity
References
Publications (0)
Data not yet available