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This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following minimal prior treatment requirement:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | FATE-NK100 is a donor-derived NK cell product comprising ex vivo activated effector cells with enhanced anti-tumor activity. FATE-NK100 is administered to determine the maximum tolerated doze/maximum feasible dose (MTD/MFD). Interleukin-2 (IL-2) remains the only FDA approved drug that is capable of promoting NK cells activation and survival. Lymphodepletion with Cyclophosphamide and Fludarabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FATE-NK100 | Biological | FATE-NK100 Infusion (Day 0) The FATE-NK100 product will be placed in approximately 100 cc of 5% human serum albumin.
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Doze of FATE-NK100 | To determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of FATE-NK100 when administered via intraperitoneal catheter in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Incidence of objective response rate (ORR) of the FATE-NK100 treatment | Day 28 |
| Progression-Free Survival (PFS) | Incidence of progression-free survival of treated patients 6 months post-infusion |
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Inclusion Criteria:
Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirement (no limit to the maximum number of prior treatments):
Measurable disease per RECIST within the abdomen and pelvis. Extra-peritoneal disease is permitted; however each lesion must be < 5 cm at the largest diameter.
Available HLA haploidentical or better but not fully HLA-matched (2/4 or 3/4 antigens) related donor (aged 18 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus who is CMV seropositive.
At least 18 years of age, but not older than 75 years
GOG Performance Status 0, 1, or 2
Adequate organ function within 14 days of study registration (28 days for pulmonary and cardiac) defined as:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Geller, MD, MS | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| Interleukin-2 | Drug | Interleukin-2 (begin Day 0): 6 million units three times a week for a total of 6 doses. For patients weighing less than 45 kilograms, the IL-2 will be given at 3 million units/m2 three times a week for 6 doses. The 1st dose will be given immediately (within 30 minutes) after the FATE-NK100 cell infusion on Day 0 as an inpatient. The remaining doses will be given in an outpatient setting. |
|
|
| 6 Months |
| Overall Survival (OS) | Incidence of overall survival of treated patients 6 months post-infusion | 6 Months |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |