Donor-derived T-lymphocyte enriched leukocyte preparation depleted ex vivo of host-alloreactive T cells.

Extended indication	Adjunctive treatment to a haploidentical, T-cell depleted haematopoietic stem cell transplantation (HSCT) in adult patients with high-risk haematological malignancies.
Therapeutic value	No judgement
Registration phase	Registration application pending

Product

Active substance	Donor-derived T-lymphocyte enriched leukocyte preparation depleted ex vivo of host-alloreactive T cells.
Domain	Oncology and Hematology
Main indication	Other hematology
Extended indication	Adjunctive treatment to a haploidentical, T-cell depleted haematopoietic stem cell transplantation (HSCT) in adult patients with high-risk haematological malignancies.
Proprietary name	ATIR101
Manufacturer	Kiadis
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host-alloreactive T cells using photodynamic treatment.

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Particularity	New medicine
Submission date	June 2017
Expected Registration	January 2019
Orphan drug	Yes
Registration phase	Registration application pending
Additional remarks	Restart of the procedure 27 March 2018 - responses received to Day 120 List of Questions.

Therapeutic value	No judgement
Duration of treatment	Average 42 day / days
Dosage per administration	2x10^6 cellen/kg
References	Clinical trial NCT02500550
Additional remarks	Twee intraveneuse infusies van 2x10^6 T-cellen/kg, 42 dagen na elkaar.

Additional remarks	400-500 allogene stamceltransplantaties per jaar.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.