This clinical study is an open-label, phase 1, dose-escalation study to determine the safety,
tolerability, and pharmacokinetic (PK) properties of CRX100 in adult subjects with advanced
solid tumors. Patients will be screened and evaluated to determine whether or not they meet
stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo
generation of autologous cytokine induced killer (CIK) cells. Patients with triple-negative
breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian
cancer, and gastric cancer will be considered.
Subjects must meet all of the following criteria to be enrolled in this study:
1. Age ≥18 years at the time of consent.
2. Written informed consent in accordance with national, local, and institutional
guidelines obtained prior to any study procedures.
3. Subjects must have histologically-confirmed diagnosis of one of the following tumors:
triple negative adenocarcinoma of the breast (human epidermal growth factor receptor
2- estrogen receptor- and progesterone receptor- negative [HER2-/ER-/PR-]),
adenocarcinoma of the colon or rectum (CRC), hepatocellular carcinoma (HCC),
osteosarcoma, epithelial ovarian cancer, or gastric cancer. Documentation of the
diagnosis with the original pathology report, or a recent biopsy, is required.
4. Subjects must have relapsed disease or be refractory or intolerant to standard care,
or refusing standard therapies.
5. Subjects must have iRECIST evaluable disease using computed tomography (CT) or
magnetic resonance imaging (MRI) with IV contrast , with at least one measurable
6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of
7. Subjects must have recovered from the effects of recent surgery, radiation therapy, or
8. Subjects must be free of active infections requiring treatment doses of antibiotics,
antifungals, or antiviral medications.
9. No cellular therapy to be administered for at least 12 weeks prior to apheresis.
10. Adequate hematologic function at the time of screening, defined as: absolute
lymphocyte count (ALC) >500 cells/mm3, absolute neutrophil count (ANC) >750 cells/mm3,
hemoglobin >8 g/dL, and platelet count >50,000 cells/mm3. Hemoglobin and platelet
count thresholds must be achievable without transfusion of red blood cells or
11. Adequate organ function, defined as:
1. Renal function: serum creatinine <1.5x institutional upper limit of normal (ULN)
or calculated creatinine clearance >50 mL/min
2. Adequate hepatic function: total bilirubin ≤1.5x institutional upper limit of
normal; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x
institutional upper limit of normal, unless liver metastases are present, in
which case it must be ≤5x ULN; International Normalized Ratio (INR) ≤1.5. For
subjects with HCC, adequate hepatic function is defined as: total bilirubin ≤3x
institutional upper limit of normal, AST/ALT ≤5x institutional upper limit of
normal, INR ≤1.7, Child-Turcotte-Pugh score <8.
12. Women of childbearing potential (defined as all women physiologically capable of
becoming pregnant) must have negative serum ß-human chorionic gonadotropin (ß-HCG) or
urine pregnancy test.
13. Women of childbearing potential must agree to use highly effective methods of
contraception throughout the study and for 6 months after the last dose of CRX100.
14. Males who have partners of childbearing potential must agree to use an effective
barrier contraceptive method throughout the study and for 6 months after the last dose
15. Subjects must be willing to comply with all study procedures, requirements and
Subjects who meet any of the following criteria will be excluded from participation in this
1. Subjects with new or progressive brain metastasis. Subjects with treated brain
metastases are eligible if there is no evidence of progression for at least 4 weeks
after central nervous system-directed treatment, as ascertained by clinical
examination and brain imaging (MRI or CT) during the screening period.
2. Active or history of autoimmune disease (known or suspected). Exceptions are permitted
for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune
condition requiring only hormone replacement, psoriasis not requiring systemic
treatment, or conditions not expected to recur in the absence of an external trigger.
3. Have a condition requiring systemic treatment with either corticosteroids (>10 mg
daily prednisone or equivalent) or other immunosuppressive medications within 14 days
prior to apheresis, and within 14 days prior to infusion. Inhaled or topical steroids
and adrenal replacement doses (≤10 mg daily prednisone equivalents) are permitted in
the absence of active autoimmune disease. Short-term (<48 hr) steroid pretreatment for
contrast allergy for imaging is permitted.
4. Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C,
life-threatening illnesses unrelated to cancer, or any serious medical or psychiatric
illness that could, in the Investigator's opinion, interfere with participation in
5. Pregnant or nursing an infant (subject or household contacts).
6. Clinically significant immunodeficiency (e.g., due to underlying illness and/or
medication) in a subject or household contacts.
7. Have any underlying medical condition (including, but not limited to, ongoing or
active infection requiring treatment, symptomatic congestive heart failure, unstable
angina pectoris, or cardiac arrhythmia), psychiatric condition, or social situation
that, in the opinion of the Investigator, would compromise study administration as per
protocol or compromise the assessment of AEs.
8. Have a history of another invasive malignancy, except for the following circumstance:
individuals with a history of invasive malignancy are eligible if they have been
disease free and off treatment for at least 2 years or are deemed by the Investigator
to be at low risk for recurrence of that malignancy; individuals with the following
cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral
cavity, or cervix, localized prostate cancer, or basal cell or squamous cell carcinoma
of the skin. When enrolling a subject with another malignancy, the Investigator should
consider discussing the subject with the Medical Monitor.
9. Treatment with any investigational drug study, oncolytic viral therapy or
immunotherapy within three (3) weeks of enrollment.
10. Chemotherapy three (3) weeks prior to infusion.