KTE-X19

Unassigned

New Medicines

Relapsed or refractory mantle cell lymphoma (MCL), after 5 prior regimens

Information

Advanced therapy medicinal product (ATMP)
Gilead Sciences
Kite

Development and Regulatory status

None
None
Pre-registration (Filed)
Yes
Yes
Dec 19 · Filed in the US. The manufacturer expects to file in the EU early 2020. [6]

Category

The CAR expressing T cells are produced by modifying the patient peripheral blood mononuclear cells with a gammaretroviral vector.
Mantle cell lymphoma is a high-grade non-Hodgkin lymphoma (NHL). NHLs are a heterogeneous group of lymphoproliferative malignancies with differing patterns of behaviour and responses to treatment. MCL accounts for about 3-10% of all cases of NHL. MCL is more common in the over-50s and is three times more common in men than in women [3].
Relapsed or refractory mantle cell lymphoma (MCL), after 5 prior regimens
Intravenous infusion

Further information

Yes
Dec / 2020

Trial or other data

Jan 20 · No UK trials sites [7]
Dec 17 · NCT02601313 primary data now due Jul 18 [5]
Aug 17 · Kite is to be acquired by Gilead Sciences, with completion of the deal expected late 2017. It is not clear at present whether the Kite name will be retained for cell-based therapies [4].
Feb 17 · PII ZUMA-2 study (NCT02601313) is currently recruiting patients and is expected to complete collection of primary outcome data in Sep 17 [2].
Nov 15 · Kite initiates the pivotal PII ZUMA-2 study to evaluate the efficacy of axicabtagene ciloleucel in patients with relapsed or refractory mantle cell lymphoma (NCT02601313). The study is expected to enrol approximately 70 subjects in the US, and the enrolment is expected to expand to EU [1].

Evidence based evaluations

Relapsed or refractory chronic lymphocytic leukaemia (CLL) in adults

Information

Advanced therapy medicinal product (ATMP)
Gilead Sciences
Kite

Development and Regulatory status

None
None
Phase II Clinical Trials
Yes

Category

The CAR expressing T cells are produced by modifying the patient peripheral blood mononuclear cells with a gammaretroviral vector.
CLL is the most common leukaemia in the Western world with an incidence of 4.2 per 100,000 per year. The incidence increases to >30 per 100,000 per year at an age >80 years [1].
Relapsed or refractory chronic lymphocytic leukaemia (CLL) in adults
Intravenous infusion

Trial or other data

Jan 20 · No UK trial sites [3]

B-precursor acute lymphoblastic leukaemia (ALL) in children and young adults

Information

Advanced therapy medicinal product (ATMP)
Gilead Sciences
Kite

Development and Regulatory status

None
None
Phase II Clinical Trials
Yes
Yes

Category

The CAR expressing T cells are produced by modifying the patient peripheral blood mononuclear cells with a gammaretroviral vector.
Global incidence is about 3 per 100,000 population, with about 3 out of 4 cases occurring in children aged under 6 years. ALL represents 12% of all leukaemia (but 80% in children) [1].
B-precursor acute lymphoblastic leukaemia (ALL) in children and young adults
Intravenous infusion

Further information

Yes

Trial or other data

Jan 20 · No UK trial sites [4]

B-precursor acute lymphoblastic leukaemia (ALL) in adults

Information

Advanced therapy medicinal product (ATMP)
Gilead Sciences
Kite

Development and Regulatory status

None
None
Phase II Clinical Trials
Yes
Yes

Category

The CAR expressing T cells are produced by modifying the patient peripheral blood mononuclear cells with a gammaretroviral vector.
Global incidence is about 3 per 100,000 population, with about 3 out of 4 cases occurring in children aged under 6 years. ALL represents 12% of all leukaemia (but 80% in children) [1].
B-precursor acute lymphoblastic leukaemia (ALL) in adults
Intravenous infusion

Further information

Yes

Trial or other data

Jan 20 · No UK trial sites [5]

Evidence based evaluations