A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications



Status:Recruiting
Conditions:Prostate Cancer, Colorectal Cancer, Cancer, Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology, Hematology, Pancreatic Cancer
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/28/2018
Start Date:December 2016
End Date:August 2021
Contact:Doreen Dekker
Email:Think_info@celyad.com

Use our guide to learn which trials are right for you!

A Multi-national, Open-label, Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Administrations of NKR-2 in Patients With Different Metastatic Tumor Types (THINK - THerapeutic Immunotherapy With NKR-2)

THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I
study to assess the safety and clinical activity of multiple administrations of autologous
NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian,
bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute
myeloid leukemia and multiple myeloma).

This open-label Phase I study aims at assessing the safety and clinical activity of the NKR-2
treatment administered 3 times with a 2-week interval between each administration in
different tumor types. In absence of progressive disease at the first tumor assessment
following NKR-2 administratio, the patient will receive a new cycle of 3 administrations
maximum with a 2-week interval. The study will contain two consecutive segments: a Phase I
dose escalation and a Phase I expansion segment.

The Phase I dose escalation segment will include 2 arms, one in solid tumors and one in
hematological tumors. The dose escalation design will include 3 dose levels: The dose
escalation phase will consist of 3 cohorts (Cohorts 1-3) for the solid tumors, and 3 cohorts
(Cohorts 4-6) for the hematological tumors; with each set of 3 cohorts receiving escalating
doses of the NKR-2 therapy.

Two additional cohorts will be added in each dose escalation arm with the aim to provide a
more intense treatment during the induction treatment. These additional cohorts in both the
solid arm (cohort 8-9 - only in CRC) and in the hematological arm of the study (cohort 10-11
- only in AML/MDS) will therefore evaluate a tighter schedule of NKR-2 injections with the
three first injections within the induction cycle separated by a 1-week interval followed two
weeks later by a second cycle (cycle 2) with a 2-weeks interval between each three NKR 2
injections. These cohorts will each enroll 3 patients in case of no DLT. Based on safety and
early clinical data from these cohorts, the specific schedule of cohorts 8-11 might be
selected for the expansion.

Inclusion Criteria:

1. Men or women ≥ 18 years old at the time of signing the ICF

2. Pati• Men or women ≥ 18 years old at the time of signing the ICF,

- Patient with a CRC, epithelial ovarian cell or fallopian tube carcinoma,
urothelial carcinoma, TNBC, pancreatic cancer, AML/MDS or MM,

- Disease must be measurable according to the corresponding guidelines,

- Patient with an ECOG performance status 0 or 1, and AML patients with anemia
resulting in an ECOG performance status of 2,

- Patient with adequate bone marrow reserve, hepatic and renal functions.

- Patients must have sufficient pulmonary functions with a Forced Expiratory Volume
in the first second (FEV-1)/Forced Vital Capacity (FVC) ≥ 0.7 with FEV-1 ≥ 50%
predicted.

Detailed disease specific criteria exist and can be discussed with contacts listed below.

Exclusion Criteria:

1. Main inclusion criteria are:

- Men or women ≥ 18 years old at the time of signing the ICF,

- Patient with a CRC, epithelial ovarian cell or fallopian tube carcinoma, urothelial
carcinoma, TNBC, pancreatic cancer, AML/MDS or MM,

- Disease must be measurable according to the corresponding guidelines,

- Patient with an ECOG performance status 0 or 1, and AML patients with anemia resulting
in an ECOG performance status of 2,

- Patient with adequate bone marrow reserve, hepatic and renal functions.

- Patients must have sufficient pulmonary functions with a Forced Expiratory Volume in
the first second (FEV-1)/Forced Vital Capacity (FVC) ≥ 0.7 with FEV-1 ≥ 50% predicted.

Main exclusion criteria are:

- Patient with a tumor metastasis in the central nervous system,

- Patients who have received another cancer therapy within 2 weeks before the planned
day for the apheresis (except hydroxyurea for AML patients),

- Patients who receive or are planned to receive any other investigational product
within the 3 weeks before the planned day for the first NKR-2 administration (except
hydroxyurea for AML patients),

- Patient is under systemic immunosuppressive drugs, unless specific cases authorized
per protocol,

- Patients who have received other cell therapies,

- Patients who underwent major surgery within 4 weeks before the planned day for the
first NKR-2 administration.

- Patient cannot present with history of idiopathic pulmonary fibrosis, organizing
pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute
exacerbation of chronic obstructive pulmonary disease (COPD).
We found this trial at
3
sites
Brussels,
Phone: +32 2 764.42.17
?
mi
from
Brussels,
Click here to add this to my saved trials
Buffalo, New York
Phone: 877-275-7724
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Tampa, Florida
Phone: 813-745-1040
?
mi
from
Tampa, FL
Click here to add this to my saved trials