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HSC835 · 2 trials · 17 indications
This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
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.
| Arm | Type | Description |
|---|---|---|
| HSC835 | EXPERIMENTAL | Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen. |
| Name | Type | Description |
|---|---|---|
| HSC835 | DRUG | HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC). |
Inclusion Criteria: * Patients with a diagnosis that qualifies them for UCBT * 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 ...
HSC835 is an investigational therapy being studied for use in patients with hematological malignancies, including acute myelocytic leukemia, and in patients undergoing single umbilical cord blood transplantation. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.
HSC835 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company has sponsored clinical trials to evaluate the safety and tolerability of HSC835 in patients with certain blood cancers and transplant settings.
HSC835 has been studied in Phase 1 and Phase 2 clinical trials. Both trials have been completed. The drug is investigational and has not been approved by regulatory authorities. Its development status reflects early-stage clinical evaluation in hematological malignancies and cord blood transplantation.
HSC835 has been evaluated in two completed clinical trials. NCT01474681 was a Phase 1 study of safety and tolerability in patients with hematological malignancies, enrolling 27 participants. NCT01930162 was a Phase 2 study in patients undergoing single umbilical cord blood transplant, enrolling 9 participants. Both were conducted in the United States.
HSC835 is the name used in clinical trials for this investigational therapy. No alternative names have been reported for this drug in the available clinical trial information. It is distinct from other agents and is identified solely by the name HSC835 in the studies conducted by Novartis.