TriangleNCT03132922 · STUDY IN CONTEXT
MAGE-A4ᶜ¹º³²T for Multi-Tumor
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.
Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.
ORR, defined as the proportion of participants with Best Overall Response (BOR) of confirmed completed response (CR) or partial response (PR) among participants with measurable disease at Baseline. The ORR was based on the assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by local radiologist. Participants with unknown or missing response were treated as non-responders.
BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)
TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- trial label
- MAGE-A4ᶜ¹º³²T for Multi-Tumor
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0000
- source section id
- NCT03132922-om-0000
- source outcome index
- 0
- endpoint
- Adverse Events (AE) Including Serious Adverse Events (SAE)
- endpoint definition
- An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.
- time origin
- From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0001
- source section id
- NCT03132922-om-0001
- source outcome index
- 1
- endpoint
- Peak Persistence
- endpoint definition
- Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
- time origin
- From afamitresgene autoleucel infusion up to 18 months post-infusion
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for persistence
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0002
- source section id
- NCT03132922-om-0002
- source outcome index
- 2
- endpoint
- Replication Competent Lentivirus (RCL)
- endpoint definition
- The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.
- time origin
- From afamitresgene autoleucel infusion to 3 months post-infusion
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for VSV-G by qPCR (RCL)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0003
- source section id
- NCT03132922-om-0003
- source outcome index
- 3
- endpoint
- Overall Response Rate (ORR)
- endpoint definition
- ORR, defined as the proportion of participants with Best Overall Response (BOR) of confirmed completed response (CR) or partial response (PR) among participants with measurable disease at Baseline. The ORR was based on the assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by local radiologist. Participants with unknown or missing response were treated as non-responders.
- time origin
- From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- mITT Population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0004
- source section id
- NCT03132922-om-0004
- source outcome index
- 4
- endpoint
- Best Overall Response (BOR)
- endpoint definition
- BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)
- time origin
- From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0005
- source section id
- NCT03132922-om-0005
- source outcome index
- 5
- endpoint
- Time to Response (TTR)
- endpoint definition
- TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.
- time origin
- From afamitresgene autoleucel infusion until first documented confirmed CR or PR
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel achieving CR or PR.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Afamitresgene Autoleucel, Group 1
- regimen
- Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Afamitresgene Autoleucel, Group 2
- regimen
- Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Afamitresgene Autoleucel, Group 3 + Expansion
- regimen
- Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- regimen
- Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Afamitresgene Autoleucel, Group 1
- regimen
- Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Afamitresgene Autoleucel, Group 2
- regimen
- Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Afamitresgene Autoleucel Group 3 + Expansion
- regimen
- Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- regimen
- Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Afamitresgene Autoleucel, Group 1
- regimen
- Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Afamitresgene Autoleucel, Group 2
- regimen
- Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Afamitresgene Autoleucel, Group 3 + Expansion
- regimen
- Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- regimen
- Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03132922-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- harm key
- EG000
- source section id
- NCT03132922-ae
- event group key
- EG000
- event group label
- Afamitresgene Autoleucel, Group 1
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
- event definition
- SAEs were collected
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- harm key
- EG001
- source section id
- NCT03132922-ae
- event group key
- EG001
- event group label
- Afamitresgene Autoleucel, Group 2
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
- event definition
- SAEs were collected
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- harm key
- EG002
- source section id
- NCT03132922-ae
- event group key
- EG002
- event group label
- Afamitresgene Autoleucel, Group 3 + Expansion
- serious affected
- 23
- serious at risk
- 32
- other affected
- 32
- other at risk
- 32
- frequency threshold
- 5
- collection period
- From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
- event definition
- SAEs were collected
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liposarcoma
- nct id
- NCT03132922
- harm key
- EG003
- source section id
- NCT03132922-ae
- event group key
- EG003
- event group label
- Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
- event definition
- SAEs were collected
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice