Clinical trial · Interventional
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
A First-in-human, Single-arm, Single-center, Open-label, Proof-of-concept Study to Evaluate the Safety and Tolerability of Infusing HSC835 (LFU835-expanded Umbilical Cord Blood Hematopoietic Stem Cells) in Patients With Hematological Malignancies
NCT01474681CI-TRIAL-00049183completedPhase 1 / Phase 2Results postedClinicalTrials.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 study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myelocytic Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Burkitt's Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Follicular Lymphomas | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| High Grade Lymphomas | — | UNRESOLVED | — |
| Large-cell Lymphoma | — | UNRESOLVED | — |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSC835 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSC835
- description
- HSC835 infusion
- interventionNames
- Biological: HSC835
Primary outcomes (1)
- measure
- Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.
- timeFrame
- 32 days
- description
- The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis that qualifies them for a DUCBT * Absence of recent active mold infection * Adequate organ function * Availability of eligible donor material Exclusion Criteria: * Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used * Human immunodeficiency virus (HIV) infection * Active infection * Extensive prior chemotherapy * Prior myeloablative allotransplantation or autologous transplant.
References
Publications (0)
Data not yet available
No reference posted for this study.