Trial Outcomes & Findings for MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (NCT NCT05708924)

NCT ID: NCT05708924

Last Updated: 2025-08-14

Results Overview

The primary objective of the study is 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. Monitor the patient for signs of acute infusion related reaction during and after IP infusion. For IV infusion signs of a possible reaction are rigors and chills, rash, urticaria, hypotension, dyspnea, and angioedema.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

48 months

Results posted on

2025-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	IP FT538 Monotherapy 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 FT538: FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.	IP FT538 + Enoblituzumab Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab FT538: FT538 IP at assigned dose level on Day 1, Day 8, and Day 15. Enoblituzumab: Enoblituzumab 15 mg/kg IV begin on Day -6 and continuing once every 3 weeks beginning on Day 22 until disease progression or unacceptable toxicity - refer to Section 7.2.1 for timing of the enoblituzumab dose on Day 22 if steroid pre-meds are needed due to an infusion reaction with the 1st enoblituzumab dose as there is a 14 day ban on corticosteroid use after the last dose of FT538
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IP FT538 Monotherapy n=1 Participants 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 FT538: FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.	IP FT538 + Enoblituzumab Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab FT538: FT538 IP at assigned dose level on Day 1, Day 8, and Day 15. Enoblituzumab: Enoblituzumab 15 mg/kg IV begin on Day -6 and continuing once every 3 weeks beginning on Day 22 until disease progression or unacceptable toxicity - refer to Section 7.2.1 for timing of the enoblituzumab dose on Day 22 if steroid pre-meds are needed due to an infusion reaction with the 1st enoblituzumab dose as there is a 14 day ban on corticosteroid use after the last dose of FT538	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 months

Population: Trial was terminated before the outcome measure data were collected.

The primary objective of the study is 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. Monitor the patient for signs of acute infusion related reaction during and after IP infusion. For IV infusion signs of a possible reaction are rigors and chills, rash, urticaria, hypotension, dyspnea, and angioedema.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 months

Population: Trial was terminated before the outcome measure data were collected.

Overall response rate is defined as number of patients who have a partial or complete response to therapy divided by the total number of patients who received treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 months

Population: Trial was terminated before the outcome measure data were collected.

Number of participants experiencing progression free survival at one year follow up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 months

Population: Trial was terminated before the outcome measure data were collected.

Number of participants experiencing adverse events with the combination of Enoblituzumab and FT538

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 months

Population: Trial was terminated before the outcome measure data were collected.

Tumors will be biopsied to assess tumor microenvironment.

Outcome measures

Outcome data not reported

Adverse Events

IP FT538 Monotherapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

IP FT538 + Enoblituzumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IP FT538 Monotherapy n=1 participants at risk 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 FT538: FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.	IP FT538 + Enoblituzumab Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab FT538: FT538 IP at assigned dose level on Day 1, Day 8, and Day 15. Enoblituzumab: Enoblituzumab 15 mg/kg IV begin on Day -6 and continuing once every 3 weeks beginning on Day 22 until disease progression or unacceptable toxicity - refer to Section 7.2.1 for timing of the enoblituzumab dose on Day 22 if steroid pre-meds are needed due to an infusion reaction with the 1st enoblituzumab dose as there is a 14 day ban on corticosteroid use after the last dose of FT538
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 4 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 5 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.
Investigations Neutrophil count decreased	100.0% 1/1 • Number of events 3 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.
Investigations White blood cell decreased	100.0% 1/1 • Number of events 9 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.
Metabolism and nutrition disorders Hypercalcemia	100.0% 1/1 • Number of events 1 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • Number of events 1 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.
Musculoskeletal and connective tissue disorders Buttock pain	100.0% 1/1 • Number of events 3 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	100.0% 1/1 • Number of events 1 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.	— 0/0 • 1 month No participants enrolled onto IP FT538 + Enoblituzumab arm.

Additional Information

Dr. Melissa Geller

Masonic Cancer Center

Phone: 612-626-3111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place