A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Ind… (NCT03018405) | Clinical Trial Compass
UnknownPhase 1/2
A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications
United States, Belgium146 participantsStarted 2016-12
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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, …
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NKR-2 infusion