ClinicalTrials.gg
Active, not recruitingNCT04044768Updated Nov 5, 2026Results posted

Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

A Phase 2 interventional study of afamitresgene autoleucel (previously ADP-A2M4) in Synovial Sarcoma and Myxoid Liposarcoma, sponsored by USWM CT, LLC. Active, not recruiting at 26 sites in 5 countries. Open to participants aged 10 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by USWM CT, LLC · Phase 2, Interventional, and Treatment

Updated Nov 5, 2026Eligibility revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
10 Years to 75 Years
Sex
All
01

Study summary

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .

02

Conditions studied

  • Synovial Sarcoma
  • Myxoid Liposarcoma

Keywords

  • Cell Therapy
  • T Cell Therapy
  • SPEAR T Cell
  • Sarcoma
  • MRCLS
  • MAGE A-4
  • Immuno-oncology
03

In context

Sarcoma, Synovial

133 studies on the registry are indexed under Sarcoma, Synovial; 29 are open to participants now.

This study's enrollment of 52 is above the median of 46 across 117 interventional studies indexed under Sarcoma, Synovial.

Browse Sarcoma, Synovial studies →

Lead sponsor

USWM CT, LLC is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 5, 2026. See what changed

Ages eligible
10 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria

  • Age ≥16 (10 years at selected sites) and \<=75 years
  • Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) or myxoid liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by cytogenetics.
  • Previously received either an anthracycline or ifosfamide containing regimen.
  • according to v1.1 prior to lymphodepletion
  • HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 positive
  • Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only (United States and Canada): Tumor (either an or a fresh biopsy) shows MAGE-A4 expression of ≥2+ staining in ≥30% of the cells by immunohistochemistry.
  • Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old:

Lansky Score ≥60%.

  • (LVEF) ≥50%.

Note: other protocol defined Inclusion criteria may apply

Key Exclusion Criteria:

  • HLA-A*02:05 in either allele
  • Received or plans to receive the following therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor (TKI) (e.g. pazopanib), Immune therapy (including monoclonal antibody therapy, ,), Anti-cancer Vaccine, Gene therapy using an integrating vector (subjects who have received a gene therapy using a lentiviral vector may be eligible for the study), or any other therapy, treatment or interventional clinical trial, hematopoietic stem cell transplant, Radiotherapy to the target lesions, Major surgery
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
  • History of or immune mediated disease
  • Symptomatic including .
  • Other prior that is not considered by the Investigator to be in complete remission
  • cardiovascular disease
  • Uncontrolled intercurrent illness
  • Active infection with , virus, virus, or human T cell leukemia virus
  • Pregnant or breastfeeding

Note: other protocol defined Exclusion criteria may apply.

Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) SPEAR™ T cells

    Genetic: afamitresgene autoleucel (previously ADP-A2M4)

Interventions

  • Geneticafamitresgene autoleucel (previously ADP-A2M4)

    Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR) (Cohort 1)

    Percentage of participants with confirmed tumor response (complete \[CR\] or partial \[PR\] response) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Radiologist review (Cohort 1)

    Time frame: From T-cell infusion until disease progression/recurrence as of data cut off (up to 2 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression.

Secondary outcomes

  1. Adverse Events (AE) Including Serious Adverse Events (SAE), SAE, and Adverse Events of Special Interest (AESI) (Cohort 1)

    An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAE), SAE and AESI including cytokine release syndrome, neurotoxicity, ICANS, prolonged cytopenia are presented.

    Time frame: AEs, SAEs, and AESIs were collected at each visit from the start of lymphodepletion of the first subject until the last subject discontinued the interventional phase in cohort 1 as of the safety cut off (up to 3.2 years).

  2. The Number of Participants With Replication Competent Lentivirus (RCL)

    The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence.

    Time frame: From T-cell infusion to months 3, 6, and 12 post-infusion, then annually post-infusion (up to 2.8 years as of the data cut off).

  3. Insertional Oncogenesis (IO)

    Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples was subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The count of participants with integration sites representing more than 5% of all unique sites is presented.

    Time frame: From 10 months post T-cell infusion up to 20 months post T-cell infusion (as of the data cut off)

  4. Best Overall Response (BOR) (Cohort 1)

    BOR is the best response recorded from the start of T-cell infusion until disease progression/recurrence as assessed by Independent Radiologist review. Response categories are confirmed CR, confirmed PR, stable disease and confirmed progressive disease (PD). Best overall response is a stable disease, if CR or PR are unconfirmed.

    Time frame: From T-cell infusion until disease progression/recurrence as of data cut off (up to 2.6 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression.

  5. Time to Response (TTR) (Cohort 1)

    TTR was defined as the interval (weeks) from the date of T-cell infusion to the earliest date of the first documented confirmed CR or confirmed PR as assessed by Independent Radiologist review. TTR (in weeks) = \[date of initial confirmed CR or PR - date of T-cell infusion + 1\]/7.

    Time frame: From T-cell infusion until first documented confirmed CR or confirmed PR. Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression.

  6. Duration of Response (DoR) (Cohort 1)

    DoR (in months) is defined as ((date of PD (or censoring) - date of initial confirmed CR/PR + 1)/365.25)\*12 as assessed by Independent Radiologist review. Outcome Measure not yet reached as participants are ongoing in study

    Time frame: From initial confirmed response (CR or PR) until PD (or censored date) as of data cut off.

  7. Progression Free Survival (PFS) (Cohort 1)

    PFS is defined as the time from T-cell infusion to the date of the first documentation of PD or death due to any cause, whichever occurs first, as assessed by Independent Radiologist review. PFS (in weeks) was calculated as (date of PD/death \[or censored date\] - first T-cell infusion date + 1)/7.

    Time frame: From T-cell infusion until first documented PD or death due to any cause (or censored date), whichever occurs first, as of data cut off (up to 2.6 years). Response was assessed at Week 4, 8,12,16, 24, and every 2 months until confirmed PD

  8. Overall Survival (OS) (Cohort 1)

    OS is defined as the time from the date of T-cell infusion to the date of death (due to any reason) or censored date. OS in months was calculated as ((death date - first T-cell infusion date + 1)/365.25)\*12. Outcome Measure not yet reached as participants are ongoing in study

    Time frame: From T-cell infusion to death due to any reason (or censored date) as of data cut off (up to 2.6 years).

  9. Peak Persistence (Cohort 1)

    Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).

    Time frame: From T-cell infusion to 3.2 years (as of data cut off).

  10. Time Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs

    Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry

    Time frame: 2.5 years

  11. Quantitation of Genetically Engineered T-cells in PBMCs

    Quantitation of genetically engineered T-cells in PBMCs by flow cytometry

    Time frame: 2.5 years

  12. Time Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs

    Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by qPCR

    Time frame: 2.5 years

  13. In Vitro Diagnostic (IVD) Assay for Screening

    Development and validation of the MAGE-A4 antigen expression companion diagnostic assay

    Time frame: 2.5 years

07

Results

Posted Jan 13, 2025

Participant flow

This was a Phase 2, single-arm, open-label study of afamitresgene autoleucel in HLA-A\*02+ participants with MAGE-A4 expressing metastatic or inoperable (advanced) synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) (Cohort 1). Eligible participants received between 1.0 × 10\^9 to 10.0 × 10\^9 transduced cells of afamitresgene autoleucel, administered as a single IV infusion following lymphodepletion with fludarabine and cyclophosphamide.

Participant flow — Overall Study
MilestoneSynovial SarcomaMRCLS
Started448
Received afamitresgene autoleucel448
Completed368
Not completed80
Withdrew: Ongoing in interventional phase at data cut-off80

Outcome measures

PrimaryOverall Response Rate (ORR) (Cohort 1)

Percentage of participants with confirmed tumor response (complete \[CR\] or partial \[PR\] response) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Radiologist review (Cohort 1)

Time frame:
From T-cell infusion until disease progression/recurrence as of data cut off (up to 2 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression.
Reported as:
Number · percentage of participants
Overall Response Rate (ORR) (Cohort 1)
percentage of participantsSynovial SarcomaMRCLS
Overall Response Rate (ORR) (Cohort 1)38.6 (24.36 to 54.50)25.0 (3.19 to 65.09)
SecondaryAdverse Events (AE) Including Serious Adverse Events (SAE), SAE, and Adverse Events of Special Interest (AESI) (Cohort 1)

An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAE), SAE and AESI including cytokine release syndrome, neurotoxicity, ICANS, prolonged cytopenia are presented.

Time frame:
AEs, SAEs, and AESIs were collected at each visit from the start of lymphodepletion of the first subject until the last subject discontinued the interventional phase in cohort 1 as of the safety cut off (up to 3.2 years).
Reported as:
Count of participants · Participants
Adverse Events (AE) Including Serious Adverse Events (SAE), SAE, and Adverse Events of Special Interest (AESI) (Cohort 1)
ParticipantsSynovial SarcomaMRCLS
AE including SAE448
SAE233
AESI - cytokine release syndrome334
AESI- ICANS10
AESI- Prolonged cytopenia at Week 491
SecondaryThe Number of Participants With Replication Competent Lentivirus (RCL)

The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence.

Time frame:
From T-cell infusion to months 3, 6, and 12 post-infusion, then annually post-infusion (up to 2.8 years as of the data cut off).
Reported as:
Count of participants · Participants
The Number of Participants With Replication Competent Lentivirus (RCL)
ParticipantsSynovial SarcomaMRCLS
The Number of Participants With Replication Competent Lentivirus (RCL)00
SecondaryInsertional Oncogenesis (IO)

Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples was subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The count of participants with integration sites representing more than 5% of all unique sites is presented.

Time frame:
From 10 months post T-cell infusion up to 20 months post T-cell infusion (as of the data cut off)
Reported as:
Count of participants · Participants
Insertional Oncogenesis (IO)
ParticipantsSynovial SarcomaMRCLS
Insertional Oncogenesis (IO)00
SecondaryBest Overall Response (BOR) (Cohort 1)

BOR is the best response recorded from the start of T-cell infusion until disease progression/recurrence as assessed by Independent Radiologist review. Response categories are confirmed CR, confirmed PR, stable disease and confirmed progressive disease (PD). Best overall response is a stable disease, if CR or PR are unconfirmed.

Time frame:
From T-cell infusion until disease progression/recurrence as of data cut off (up to 2.6 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression.
Reported as:
Count of participants · Participants
Best Overall Response (BOR) (Cohort 1)
ParticipantsSynovial SarcomaMRCLS
Complete Response00
Partial Response172
Stable Disease234
Progressive Disease42
SecondaryTime to Response (TTR) (Cohort 1)

TTR was defined as the interval (weeks) from the date of T-cell infusion to the earliest date of the first documented confirmed CR or confirmed PR as assessed by Independent Radiologist review. TTR (in weeks) = \[date of initial confirmed CR or PR - date of T-cell infusion + 1\]/7.

Time frame:
From T-cell infusion until first documented confirmed CR or confirmed PR. Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression.
Reported as:
Median · Weeks
Time to Response (TTR) (Cohort 1)
WeeksSynovial SarcomaMRCLS
Time to Response (TTR) (Cohort 1)4.9 (4.286 to 8.286)6.2 (4.286 to 8.143)
SecondaryDuration of Response (DoR) (Cohort 1)

DoR (in months) is defined as ((date of PD (or censoring) - date of initial confirmed CR/PR + 1)/365.25)\*12 as assessed by Independent Radiologist review. Outcome Measure not yet reached as participants are ongoing in study

Time frame:
From initial confirmed response (CR or PR) until PD (or censored date) as of data cut off.

Results for this outcome have not been posted.

SecondaryProgression Free Survival (PFS) (Cohort 1)

PFS is defined as the time from T-cell infusion to the date of the first documentation of PD or death due to any cause, whichever occurs first, as assessed by Independent Radiologist review. PFS (in weeks) was calculated as (date of PD/death \[or censored date\] - first T-cell infusion date + 1)/7.

Time frame:
From T-cell infusion until first documented PD or death due to any cause (or censored date), whichever occurs first, as of data cut off (up to 2.6 years). Response was assessed at Week 4, 8,12,16, 24, and every 2 months until confirmed PD
Reported as:
Median · Weeks
Progression Free Survival (PFS) (Cohort 1)
WeeksSynovial SarcomaMRCLS
Progression Free Survival (PFS) (Cohort 1)16.4 (12.000 to 25.286)10.6 (3.714 to 32.000)
SecondaryOverall Survival (OS) (Cohort 1)

OS is defined as the time from the date of T-cell infusion to the date of death (due to any reason) or censored date. OS in months was calculated as ((death date - first T-cell infusion date + 1)/365.25)\*12. Outcome Measure not yet reached as participants are ongoing in study

Time frame:
From T-cell infusion to death due to any reason (or censored date) as of data cut off (up to 2.6 years).

Results for this outcome have not been posted.

SecondaryPeak Persistence (Cohort 1)

Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).

Time frame:
From T-cell infusion to 3.2 years (as of data cut off).
Reported as:
Median · DNA copies/microgram
Peak Persistence (Cohort 1)
DNA copies/microgramSynovial SarcomaMRCLS
Peak Persistence (Cohort 1)229562.050 (18552.9 to 635824.4)203534.150 (63586.2 to 346468.3)
SecondaryTime Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs

Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry

Time frame:
2.5 years

Results for this outcome have not been posted.

SecondaryQuantitation of Genetically Engineered T-cells in PBMCs

Quantitation of genetically engineered T-cells in PBMCs by flow cytometry

Time frame:
2.5 years

Results for this outcome have not been posted.

SecondaryTime Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs

Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by qPCR

Time frame:
2.5 years

Results for this outcome have not been posted.

SecondaryIn Vitro Diagnostic (IVD) Assay for Screening

Development and validation of the MAGE-A4 antigen expression companion diagnostic assay

Time frame:
2.5 years

Results for this outcome have not been posted.

Adverse events

Collected over AEs and SAEs were collected at each visit from the start of lymphodepletion of the first subject until the last subject discontinued the interventional phase in cohort 1 as of the safety cut off (up to 3.2 years).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Synovial Sarcoma24/44 (54.5%)23/44 (52.3%)44/44 (100%)
MRCLS7/8 (87.5%)3/8 (37.5%)8/8 (100%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventSynovial SarcomaMRCLS
Cytokine release syndromeImmune system disorders4/441/8
PyrexiaGeneral disorders1/441/8
Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/441/8
SARS-CoV-2 test positiveInvestigations0/441/8
Back painMusculoskeletal and connective tissue disorders1/441/8
Musculoskeletal painMusculoskeletal and connective tissue disorders0/441/8
Spinal cord compressionNervous system disorders1/441/8
Pleural effusionRespiratory, thoracic and mediastinal disorders3/440/8
Pulmonary embolismRespiratory, thoracic and mediastinal disorders2/440/8
EmpyemaInfections and infestations2/440/8
Most frequent other events
Showing 10 of 60
Most frequent other events
EventSynovial SarcomaMRCLS
Lymphocyte count decreasedInvestigations34/446/8
Neutrophil count decreasedInvestigations26/446/8
White blood cell count decreasedInvestigations30/444/8
NauseaGastrointestinal disorders29/444/8
Cytokine release syndromeImmune system disorders29/443/8
ConstipationGastrointestinal disorders14/445/8
AnaemiaBlood and lymphatic system disorders18/444/8
Abdominal painGastrointestinal disorders10/443/8
FatigueGeneral disorders15/443/8
Decreased appetiteMetabolism and nutrition disorders10/443/8

Baseline characteristics

Participants who received T-cell infusion in cohort 1 as of data cut off

Age, Categorical
Age, Categorical(Participants)Synovial SarcomaMRCLSTotal
<=18 years000
Between 18 and 65 years41849
>=65 years303
Age, Continuous
Age, Continuous(years)Synovial SarcomaMRCLSTotal
Mean41.0 ± 13.0743.4 ± 12.2241.4 ± 12.86
Sex: Female, Male
Sex: Female, Male(Participants)Synovial SarcomaMRCLSTotal
Female22224
Male22628
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Synovial SarcomaMRCLSTotal
Hispanic or Latino202
Not Hispanic or Latino38543
Unknown or Not Reported437
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Synovial SarcomaMRCLSTotal
American Indian or Alaska Native000
Asian303
Native Hawaiian or Other Pacific Islander000
Black or African American202
White39645
More than one race000
Unknown or Not Reported022
08

Study locations

26 sites
09

References and documents

Publications

  • D'Angelo SP, Araujo DM, Abdul Razak AR, Agulnik M, Attia S, Blay JY, Carrasco Garcia I, Charlson JA, Choy E, Demetri GD, Druta M, Forcade E, Ganjoo KN, Glod J, Keedy VL, Le Cesne A, Liebner DA, Moreno V, Pollack SM, Schuetze SM, Schwartz GK, Strauss SJ, Tap WD, Thistlethwaite F, Valverde Morales CM, Wagner MJ, Wilky BA, McAlpine C, Hudson L, Navenot JM, Wang T, Bai J, Rafail S, Wang R, Sun A, Fernandes L, Van Winkle E, Elefant E, Lunt C, Norry E, Williams D, Biswas S, Van Tine BA. Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial. Lancet. 2024 Apr 13;403(10435):1460-1471. doi: 10.1016/S0140-6736(24)00319-2. Epub 2024 Mar 27. PubMed 38554725 ↗
  • Sanderson JP, Crowley DJ, Wiedermann GE, Quinn LL, Crossland KL, Tunbridge HM, Cornforth TV, Barnes CS, Ahmed T, Howe K, Saini M, Abbott RJ, Anderson VE, Tavano B, Maroto M, Gerry AB. Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy. Oncoimmunology. 2019 Nov 24;9(1):1682381. doi: 10.1080/2162402X.2019.1682381. eCollection 2020. PubMed 32002290 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

1 registry update since Sep 25, 2026
Eligibility
1 criterion edited
What changed in the criteria
  • EditedTumor shows MAGE-A4 expression confirmed by central laboratory. North America Only (United States and Canada): Tumor (either an archival specimen or a fresh biopsy) shows MAGE-A4 expression of ≥12+ staining in ≥1030% of the cells by immunohistochemistry.
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Eligibility 1 criterion edited
    What changed in the criteria
    • EditedTumor shows MAGE-A4 expression confirmed by central laboratory. North America Only (United States and Canada): Tumor (either an archival specimen or a fresh biopsy) shows MAGE-A4 expression of ≥12+ staining in ≥1030% of the cells by immunohistochemistry.
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT04044768
Lead sponsor
USWM CT, LLC
Responsible party
Sponsor
First posted
Aug 5, 2019
Start date
Aug 13, 2019
Primary completion
Aug 29, 2021
Completion
Apr 1, 2038 (estimated)
Results posted
Jan 13, 2025
Last update
Nov 5, 2026

Study contacts

Dejka Araujo, MD
principal investigator · MD Anderson Cancer Center; Houston TX 77030

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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