MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

University of Minnesota (UMN)

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor; Peritoneal Cancer; Fallopian Tube Cancer; Cancer; Ovarian Cancer

Treatments: Biological: Enoblituzumab; Drug: FT538

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05708924

2021LS103

P01CA111412 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To determine the maximum tolerated dose (MTD) of FT538 monotherapy when administered via intraperitoneal (IP) catheter and in combination with intravenous (IV) enoblituzumab in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirements (no limit to the maximum number of prior treatments).
• Platinum Resistant: may receive FT538 as 2nd line (as 1st salvage therapy).
• At least 18 years of age at the time of consent.
• GOG Performance Status 0, 1, or 2 (refer to Appendix I).
• Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu or enoblituzumab) start
• Pulmonary Function: Oxygen saturation ≥ 90% on room air; PFTs are performed only if known history or as medically indicated - if done, must have pulmonary function >50% corrected DLCO and FEV1.
• Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI; no clinically significant cardiovascular disease including any of the following: stroke or myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher (Appendix I).

Exclusion criteria

• Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months.
• Currently receiving or likely to require systemic immunosuppressive therapy
• Active autoimmune disease requiring systemic immunosuppressive therapy.
• History of severe asthma and currently on chronic systemic medications.
• Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy.
• Receipt of any biological therapy, chemotherapy, or radiation therapy (except palliative RT), within 2 weeks prior to the first dose of FT538
• Live vaccine within 6 weeks prior to start of lympho-conditioning.
• Known allergy to the following FT538 components: albumin (human) or dimethyl sulfoxide (DMSO).
• Prior enoblituzumab.
• Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment. (Refer to Section 5.1.8 regarding history of brain metastases.)
• Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic viral hepatitis is allowed.
• Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to patient.
• Any medical condition or clinical laboratory abnormality that, per investigator judgement, precludes safe participation in and completion of the study or that could affect compliance with protocol conduct or interpretation of results.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

IP FT538 monotherapy

Experimental group

Description:

Level -1: IP FT538 monotherapy 5 x 10\^7 cells/dose Level 1: IP FT538 monotherapy 1 x 10\^8 cells/dose Level 2: IP FT538 monotherapy 3 x 10\^8 cells/dose Level 3: IP FT538 monotherapy 1 x 10\^9 cells/dose Level 4: IP FT538 monotherapy 1.5 x 10\^9 cells/dose

Treatment:

Drug: FT538

IP FT538 + Enoblituzumab

Experimental group

Description:

Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab

Treatment:

Drug: FT538

Biological: Enoblituzumab