Trial Outcomes & Findings for Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants (NCT NCT04939701)

Last Updated: 2024-12-11

Results Overview

The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

At C2D22

Results posted on

2024-12-11

Participant Flow

Participants with Relapsed/Refractory (R/R) solid tumors and with synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCL), ovarian cancer and other solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1) (melanoma, non-small cell lung cancer \[NSCLC\] adenocarcinoma and squamous cell and esophageal squamous cell carcinoma \[ESCC\]) were recruited.

Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Study was terminated at dose expansion monotherapy after the comprehensive assessment of other studies that indicated the lack of sufficient monotherapy activity, therefore, team decided to terminate the study.

Participant milestones

Participant milestones
Measure	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received intravenous (IV) infusion of ASP0739 (human embryonic kidney cell \[HEK293\] transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a partial response (PR) or stable disease (SD) (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Phase 1: Dose Escalation (168 Days) STARTED	4	7	0
Phase 1: Dose Escalation (168 Days) COMPLETED	1	0	0
Phase 1: Dose Escalation (168 Days) NOT COMPLETED	3	7	0
Phase 2: Dose Expansion (168 Days) STARTED	0	0	5
Phase 2: Dose Expansion (168 Days) COMPLETED	0	0	1
Phase 2: Dose Expansion (168 Days) NOT COMPLETED	0	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received intravenous (IV) infusion of ASP0739 (human embryonic kidney cell \[HEK293\] transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a partial response (PR) or stable disease (SD) (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Phase 1: Dose Escalation (168 Days) Progressive disease	0	5	0
Phase 1: Dose Escalation (168 Days) Lost to Follow-up	0	1	0
Phase 1: Dose Escalation (168 Days) Lack of Efficacy	2	0	0
Phase 1: Dose Escalation (168 Days) Death	1	0	0
Phase 1: Dose Escalation (168 Days) Adverse Event	0	1	0
Phase 2: Dose Expansion (168 Days) Progressive disease	0	0	3
Phase 2: Dose Expansion (168 Days) Death	0	0	1

Baseline Characteristics

Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=4 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=7 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=5 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Total n=16 Participants Total of all reporting groups
Age, Continuous	33.3 Years STANDARD_DEVIATION 3.9 • n=5 Participants	50 Years STANDARD_DEVIATION 14.6 • n=7 Participants	46.4 Years STANDARD_DEVIATION 18.9 • n=5 Participants	44.7 Years STANDARD_DEVIATION 15.3 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (C1D1) up to C1D28

Population: DLT Evaluation Analysis Set (DEAS).The DEAS was defined as all participants in SAF excluding participants who met any of the following criteria: * Participant was discovered to have enrolled without fully satisfying eligibility criteria. * Participant received less than the planned dose in cycle 1 for reasons other than DLT. * Participant had no DLT and withdrew from the study before the end of DLT evaluation period.

DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as: * Grade (GR) ≥2 autoimmune reaction * GR 3 Immune related AEs (irAEs) that did not resolve to GR ≤1 in 3 to 5 days, febrile neutropenia with or without infection, thrombocytopenia with bleeding requiring transfusion, anemia requiring transfusion * GR 4 irAEs, neutropenia, thrombocytopenia, anemia * GR ≥3 non-hematological AE that did not resolve to GR ≤2 within 72 hours of onset, liver function test abnormality lasting ≥7 days Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 × upper limit of normal (ULN; GR≥3) without liver metastases and 8 × ULN in participants with liver metastases, AST or ALT \>3 × ULN and total bilirubin (TBL) \>2 × ULN (in participants with, Gilbert syndrome: AST or ALT \>3 × ULN and direct bilirubin \>1.5) (confirmed Hy's Law) * GR 5 toxicity, Prolonged delay (\>2 weeks) in initiating cycle 2 due to treatment-related toxicity.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=7 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=5 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=4 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose up to 198 days

Population: SAF

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=7 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=5 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=4 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) TEAEs	7 Participants	5 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) SAEs	2 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: At C1D2

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=5 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=4 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D2 Grade 0	3 Participants	2 Participants	3 Participants
Number of Participants With ECOG Performance Status at C1D2 Grade 1	3 Participants	3 Participants	0 Participants
Number of Participants With ECOG Performance Status at C1D2 Grade 2	0 Participants	0 Participants	1 Participants
Number of Participants With ECOG Performance Status at C1D2 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C1D2 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C1D2 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C1D8

Population: SAF

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=7 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=5 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=4 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C1D8 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C1D8 Grade 5	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C1D8 Grade 0	4 Participants	2 Participants	3 Participants
Number of Participants With ECOG Performance Status at C1D8 Grade 1	2 Participants	2 Participants	0 Participants
Number of Participants With ECOG Performance Status at C1D8 Grade 2	1 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C1D8 Grade 3	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At CID15

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=7 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at CID15 Grade 0	4 Participants	3 Participants	3 Participants
Number of Participants With ECOG Performance Status at CID15 Grade 1	2 Participants	1 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID15 Grade 2	1 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID15 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID15 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID15 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At CID22

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at CID22 Grade 0	4 Participants	3 Participants	2 Participants
Number of Participants With ECOG Performance Status at CID22 Grade 1	2 Participants	1 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID22 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID22 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID22 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at CID22 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C2D1

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D1 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D1 Grade 0	4 Participants	3 Participants	3 Participants
Number of Participants With ECOG Performance Status at C2D1 Grade 1	2 Participants	1 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D1 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D1 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D1 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C2D2

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=3 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D2 Grade 0	—	2 Participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 1	—	1 Participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 2	—	0 Participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 3	—	0 Participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 4	—	0 Participants	—
Number of Participants With ECOG Performance Status at C2D2 Grade 5	—	0 Participants	—

PRIMARY outcome

Timeframe: At C2D8

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D8 Grade 0	3 Participants	3 Participants	1 Participants
Number of Participants With ECOG Performance Status at C2D8 Grade 1	1 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C2D8 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D8 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D8 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D8 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C2D15

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=3 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D15 Grade 0	4 Participants	2 Participants	2 Participants
Number of Participants With ECOG Performance Status at C2D15 Grade 1	2 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C2D15 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D15 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D15 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D15 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C2D22

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=5 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C2D22 Grade 0	3 Participants	1 Participants	2 Participants
Number of Participants With ECOG Performance Status at C2D22 Grade 1	2 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C2D22 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D22 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D22 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C2D22 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C3D1

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C3D1 Grade 0	2 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C3D1 Grade 1	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C3D1 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C3D1 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C3D1 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C3D1 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C3D8

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C3D8 Grade 0	2 Participants	—	1 Participants
Number of Participants With ECOG Performance Status at C3D8 Grade 1	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D8 Grade 2	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D8 Grade 3	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D8 Grade 4	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D8 Grade 5	0 Participants	—	0 Participants

PRIMARY outcome

Timeframe: At C3D15

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C3D15 Grade 0	2 Participants	1 Participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 1	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 2	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 3	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 4	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at C3D15 Grade 5	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: At C3D22

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C3D22 Grade 0	2 Participants	—	1 Participants
Number of Participants With ECOG Performance Status at C3D22 Grade 1	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D22 Grade 2	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D22 Grade 3	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D22 Grade 4	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at C3D22 Grade 5	0 Participants	—	0 Participants

PRIMARY outcome

Timeframe: At C4D1

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C4D1 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D1 Grade 0	2 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C4D1 Grade 1	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D1 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D1 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D1 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C4D8

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C4D8 Grade 3	0 Participants	—	—
Number of Participants With ECOG Performance Status at C4D8 Grade 0	2 Participants	—	—
Number of Participants With ECOG Performance Status at C4D8 Grade 1	0 Participants	—	—
Number of Participants With ECOG Performance Status at C4D8 Grade 2	0 Participants	—	—
Number of Participants With ECOG Performance Status at C4D8 Grade 4	0 Participants	—	—
Number of Participants With ECOG Performance Status at C4D8 Grade 5	0 Participants	—	—

PRIMARY outcome

Timeframe: At C4D15

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C4D15 Grade 1	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D15 Grade 2	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D15 Grade 0	2 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C4D15 Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D15 Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C4D15 Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C4D22

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C4D22 Grade 0	—	—	1 Participants
Number of Participants With ECOG Performance Status at C4D22 Grade 1	—	—	0 Participants
Number of Participants With ECOG Performance Status at C4D22 Grade 2	—	—	0 Participants
Number of Participants With ECOG Performance Status at C4D22 Grade 3	—	—	0 Participants
Number of Participants With ECOG Performance Status at C4D22 Grade 4	—	—	0 Participants
Number of Participants With ECOG Performance Status at C4D22 Grade 5	—	—	0 Participants

PRIMARY outcome

Timeframe: At C5D1

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C5D1 Grade 4	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C5D1 Grade 0	—	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C5D1 Grade 1	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C5D1 Grade 2	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C5D1 Grade 3	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C5D1 Grade 5	—	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C5D15

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C5D15 Grade 0	—	1 Participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 1	—	0 Participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 2	—	0 Participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 3	—	0 Participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 4	—	0 Participants	—
Number of Participants With ECOG Performance Status at C5D15 Grade 5	—	0 Participants	—

PRIMARY outcome

Timeframe: At C6D1

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C6D1 Grade 1	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C6D1 Grade 3	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C6D1 Grade 5	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C6D1 Grade 0	—	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at C6D1 Grade 2	—	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at C6D1 Grade 4	—	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At C6D15

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at C6D15 Grade 0	—	1 Participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 1	—	0 Participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 2	—	0 Participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 3	—	0 Participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 4	—	0 Participants	—
Number of Participants With ECOG Performance Status at C6D15 Grade 5	—	0 Participants	—

PRIMARY outcome

Timeframe: At EOT visit (day 175)

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=7 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=3 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=2 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit Grade 0	5 Participants	2 Participants	1 Participants
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit Grade 1	1 Participants	1 Participants	1 Participants
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit Grade 2	1 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit Grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At 30 days safety follow up (day 198)

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days Grade 4	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days Grade 0	1 Participants	1 Participants	—
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days Grade 1	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days Grade 2	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days Grade 3	0 Participants	0 Participants	—
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days Grade 5	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: At 60 days safety follow up (day 228)

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days Grade 0	1 Participants	—	1 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days Grade 1	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days Grade 2	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days Grade 3	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days Grade 4	0 Participants	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days Grade 5	0 Participants	—	0 Participants

PRIMARY outcome

Timeframe: At 90 days safety follow up (day 258)

Population: SAF with available data analyzed.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=1 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days Grade 0	—	—	1 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days Grade 1	—	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days Grade 2	—	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days Grade 3	—	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days Grade 4	—	—	0 Participants
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days Grade 5	—	—	0 Participants

PRIMARY outcome

Timeframe: C1D1 up to C1D28

Population: SAF

The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=11 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Recommended Phase 2 Dose (RP2D)	—	—	1*10^8 cells/mL

PRIMARY outcome

Timeframe: From first dose up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for endpoints that were assessed by independent central review, thus data was not reported.

iORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (iCR) or partial response (iPR) per iRECIST. iORR assessments included: * iORR with confirmed response * iORR with unconfirmed response iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: Response Analysis Set (RAS): The response analysis consisted of all participants who were enrolled and received at least one dose of IP and had at least one post baseline primary efficacy measurement.

ORR was defined as the percentage of participants for each dose level whose best overall response is rated as CR or PR per RECIST v1.1. ORR assessment included: ORR with confirmed response ORR with unconfirmed response Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (ORR) by Investigator Assessment Confirmed response	0 Percentage of participants Interval 0.0 to 45.9	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 70.8
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (ORR) by Investigator Assessment Unconfirmed response	0 Percentage of participants Interval 0.0 to 45.9	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: RAS

iDCR was defined as the percentage of participants for each dose level whose best overall response is rated as confirmed and unconfirmed iCR, iPR or stable disease (iSD) per iRECIST. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. SD was defined as neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment Confirmed response	0 Percentage of participants Interval 0.0 to 45.9	25.0 Percentage of participants Interval 0.6 to 80.6	33.3 Percentage of participants Interval 0.8 to 90.6
Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment Unconfirmed response	0 Percentage of participants Interval 0.0 to 45.9	25.0 Percentage of participants Interval 0.6 to 80.6	33.3 Percentage of participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: RAS

DCR is defined as the percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1.CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Disease Control Rate Per RECIST v1.1 (DCR) by Investigator Assessment	0 Percentage of participants Interval 0.0 to 45.9	25.0 Percentage of participants Interval 0.6 to 80.6	33.3 Percentage of participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for endpoints that were assessed by independent central review, thus data was not reported.

iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by independent central review. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: FAS with available data analyzed. The dose level utilized during the expansion phase was the recommended phase 2 dose (RP2D), which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness

iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by investigator assessment. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=10 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
iPFS Per iRECIST by Investigator Assessment	52.5 Days Interval 43.0 to 106.0	—	81.0 Days Interval 51.0 to Due to low number of events, upper limit of 95% CI was not estimable.

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: FAS with available data analyzed. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

PFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per RECIST v1.1 by investigator assessment.Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=10 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Progression-Free Survival Per RECIST v1.1 (PFS) by Investigator Assessment	52.5 Days Interval 43.0 to 106.0	—	52.0 Days Interval 51.0 to Due to low number of events, upper limit of 95% CI was not estimable.

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: FAS. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

OS is defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=12 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=4 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Duration of Overall Survival (OS)	NA Days Interval 54.0 to Due to low number of events, median and upper limit of 95% CI was not estimable.	—	189.5 Days Interval 10.0 to Due to low number of events, upper limit of 95% CI was not estimable.

SECONDARY outcome

Timeframe: From first response up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for this endpoint, thus data was not reported.

iDOR as per iRECIST was defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of radiographical progression or date of censoring. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first response up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for this endpoint, thus data was not reported.

DOR as per RECIST 1.1 was defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring. CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose up to 525 days

Population: RAS

iORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per iRECIST. iORR assessments included: * iORR with confirmed response * iORR with unconfirmed response iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.

Outcome measures

Outcome measures
Measure	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=6 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=4 Participants Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=3 Participants Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
ORR Per iRECIST (iORR) by Investigator Assessment Confirmed response	0 Percentage of participants Interval 0.0 to 45.9	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 70.8
ORR Per iRECIST (iORR) by Investigator Assessment Unconfirmed response	0 Percentage of participants Interval 0.0 to 45.9	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 70.8

Adverse Events

Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL

Serious events: 2 serious events

Other events: 7 other events

Deaths: 2 deaths

Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL n=4 participants at risk Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^7 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL n=7 participants at risk Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).	Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL n=5 participants at risk Participants with SS, MRCL, ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC adenocarcinoma and squamous cell and ESCC) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10\^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.	14.3% 1/7 • Number of events 1 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.	0.00% 0/5 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	25.0% 1/4 • Number of events 1 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.	0.00% 0/7 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.	20.0% 1/5 • Number of events 1 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.
Renal and urinary disorders Renal disorder	0.00% 0/4 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.	14.3% 1/7 • Number of events 1 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.	0.00% 0/5 • For AEs: From first dose up to 198 days. For All-cause mortality: From first dose up to 525 days SAF. First dose took place at the same time as randomization.

Other adverse events

Additional Information

Clinical Transparency

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Phone: 8008887704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Publication restrictions are in place

Restriction type: OTHER