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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 monoclonal antibody 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 safety and tolerability in these patient populations.
HSC835 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS.
HSC835 has been studied in Phase 1 and Phase 2 clinical trials. Both trials are completed. It is an investigational drug and is not approved by the FDA for any use.
HSC835 has been studied in two completed clinical trials. NCT01474681 was a Phase 1 trial in patients with hematological malignancies, and NCT01930162 was a Phase 2 trial in patients undergoing single umbilical cord blood transplant. Both trials were conducted in the United States.
HSC835 is a monoclonal antibody, a type of targeted therapy that binds to specific proteins on cells. Its exact molecular target has not been disclosed in available information.