Advanced or relapsed solid tumor
Conditions
Interventions
RK-CD14MO will be given at Day1 and 22 of treatment
Sponsors
Keio University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients with histologically or cytologically documented and definitely diagnosed solid tumor 2)patients with advanced or recurrent solid tumors who are refractory to standard treatment or who have no defined standard treatment 3) Age 20 to 74 years-old at the time of consent 4)ECOG PS 0 or 1 5) Harbors one or more lesions that are evaluable by RECIST ver1.1 6)patients with sustained major organ function defined as: 7)monocyte count over 200/mm3 8)independent of blood transfusion or growth factor support within 2 weeks of obtaining consent 9)patients who are expected to live longer than 3 months at the time of consent 10) Patients who are more than 3 weeks out of initiation of prior antitumor treatment, and who have no residual side effects from that treatment 11) Patients who can give written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with symptomatic central nervous system invasion 2) patients with any kind of psychiatric disorder that compromises the ability of the subject to comply with study procedures and/or compromises the ability of the subject to give written informed consent 3)HIV or HTLV-1 antibody positive 4)HBsAg, HBcAb, HCVAb positive 5) history of autoimmune disease other than thyroid dysfunction caused by immune checkpoint inhibitors 6) history of hematological malignancies 7)immune checkpoint inhibitors within 2 months of consent 8)known severe sensitivity to human serum albumin preparation 9)known severe cardiac dysfunction or cardiovascular disease defined as, NYHA class III or IV, severe cardiovascular disease within 6 months of consent 10)patient with -uncontrolled diabetes -active infectious disease -uncontrolled blood coagulation disorders -uncontrolled hypertension 11)known history of severe infectious disease within 4 weeks of initial consent 12) history of or existing interstitial pneumonia or aspiration pneumonia 13)concurrent use of per oral of inhalation steroids 14)patient who are pregnant or breast-feeding, or expecting to be pregnant 15)patients with active tumor other than the current target tumor 16) Patients with ascites or pleural effusion requiring medical intervention such as drainage 17)no blood vessel adequate for cell collection 18)patients treated with other investigational agents within 2 months of consent 19)patients who are deemed ineligible by PI/Sub-PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion expressing DLT by Day57 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Efficacy at Day57 of treatment | — |
Countries
Japan
Contacts
Public ContactRyuji Tanosaki
Keio University Hospital Center for Transfusion Medicne and Cell Therapy
Outcome results
None listed