Trial Outcomes & Findings for NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy (NCT NCT02319824)

NCT ID: NCT02319824

Last Updated: 2017-07-05

Results Overview

CTCAE v4.03

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 2 participants
• Primary outcome timeframe: Up to 12 weeks post-treatment
• Results posted on: 2017-07-05

Participant Flow

Unit of analysis: NY-ESO-1 specific T cells

Participant milestones

Measure	Treatment (Radiation and NY-ESO-1-specific T Cells) Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV 2-3 days after completion of radiation therapy.
Overall Study STARTED	2 2
Overall Study COMPLETED	2 2
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy

Baseline characteristics by cohort

Measure	Treatment (Radiation and NY-ESO-1-specific T Cells) n=2 Participants Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy. Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
Age, Customized	40 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks post-treatment

Population: treated patients

CTCAE v4.03

Outcome measures

Measure	Treatment (Radiation and NY-ESO-1-specific T Cells) n=2 Participants Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells I60 minutes 2-3 days after completion of radiation therapy.
Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 Grade 1 Rash (likely related)	1 participants
Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 Grade 2 Shortness of breath (possibly related)	1 participants
Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 Grade 2 Cough (possibly related)	1 participants
Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 Grade 1 Cough (probably related)	1 participants

SECONDARY outcome

Timeframe: At 6 weeks post-treatment

RECIST at 6 weeks after treatment (non-radiated tumors only)

Outcome measures

Measure	Treatment (Radiation and NY-ESO-1-specific T Cells) n=2 Participants Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells I60 minutes 2-3 days after completion of radiation therapy.
T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 SD	1 Participants
T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 PD	1 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks post-treatment

Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative.

Outcome measures

Measure	Treatment (Radiation and NY-ESO-1-specific T Cells) n=2 Participants Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells I60 minutes 2-3 days after completion of radiation therapy.
Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers Number of patients with <5% of CD8 T cells tet+	2 Participants
Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers >5%	0 Participants

Adverse Events

Treatment (Radiation and NY-ESO-1-specific T Cells)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment (Radiation and NY-ESO-1-specific T Cells) n=2 participants at risk Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
Skin and subcutaneous tissue disorders Rash	50.0% 1/2 • Number of events 1 • 6 months CTCAE v4.03
Respiratory, thoracic and mediastinal disorders cough	50.0% 1/2 • Number of events 2 • 6 months CTCAE v4.03
Respiratory, thoracic and mediastinal disorders shortness of breath	50.0% 1/2 • Number of events 1 • 6 months CTCAE v4.03

Additional Information

Seth Pollack

Fred Hutchinson Cancer Research Center

Phone: 206-667-6629

Email: spollack@fhcrc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place