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HSC835

Novartis Pharmaceuticals

This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.

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

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.

Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC \> 0.5 x 109/L which occurred for all patients before 42 days post transplant.

Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement.

Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit

Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year

Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year

Number of participants with Incidence of relapse within one year

Number of participants with Overall survival (OS) within one year

Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause)

Single umbilical cord blood transplant(SUCBT) less than 18 yrs

SUCBT < 18 Yrs

Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs

SUCBT >= 18 Yrs

Double umbilical cord blood transplant (DUCBT) less than 18 yrs

DUCBT < 18 Yrs

Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs

DUCBT >= 18 Yrs

Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT\<18 yrs and SUCBT \>= 18 yrs

SUCBT

Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT\<18 yrs and DUCBT \>= 18 yrs

DUCBT

Total

Age, Continuous

Sex: Female, Male

Study Director

Infusional Toxicity 48 hrs after transplant

Absence of graft failure after 32 days

Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.

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.

Incidence of Neutrophil Recovery Within 42 Days

Incidence of Platelet Recovery Within Six Months

Predominance of HSC835

Mixed dominance

Predominance of the unmaninpulated unit

Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)

Day 100

Month 12

Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year

aGVHD-Day 100

cGVHD-Month12

Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year

Incidence of Relapse Within One Year

Overall Survival (OS) Within One Year

Disease Free Survival (DFS) Within One Year

Overall Study

Spots Global Cancer Trial Database for high grade lymphomas