Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
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|ClinicalTrials.gov Identifier: NCT04044768|
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : December 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Synovial Sarcoma Myxoid Liposarcoma||Genetic: afamitresgene autoleucel (previously ADP-A2M4)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma|
|Actual Study Start Date :||August 13, 2019|
|Actual Primary Completion Date :||October 10, 2021|
|Estimated Study Completion Date :||November 1, 2034|
|Experimental: Autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) SPEAR™ T cells||
Genetic: afamitresgene 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
- Efficacy: Overall Response Rate (ORR) [ Time Frame: 2.5 years ]ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
- Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 2.5 years ]Determine if treatment with ADP-A2M4 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs
- Evaluate safety of ADP-A2M4 through measurement of Replication -competent Retrovirus in genetically engineered T-cells [ Time Frame: 2.5 years ]Evaluation of RCL using PCR -based assay in peripheral blood.
- Measurement of T-cell clonality and insertional oncogenesis in peripheral blood mononuclear cells (PBMCs). [ Time Frame: 2.5 years ]Measurement of T-cell clonality and insertional oncogenesis in peripheral blood mononuclear cells (PBMCs )
- Efficacy: Best overall response (BOR) [ Time Frame: 2.5 years ]BOR is per RECIST V1.1.
- Time to response (TTR) [ Time Frame: 2.5 years ]For patients who are observed to respond to ADP-A2M4, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed.
- Duration of Response (DoR) [ Time Frame: 2.5 years ]For patients who are observed to respond to ADP-A2M4, the DoR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death.
- Progression Free Survival (PFS) [ Time Frame: 2.5 years ]PFS is assessed from date of infusion of ADP-A2M4 up until the date of disease progression per RECIST v1.1 or death.
- Overall Survival (OS) [ Time Frame: 15 years ]OS is assessed from date of infusion of ADP-A2M4 up until the date of patient death
- Quantitation of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]Quantitation of genetically engineered T-cells in PBMCs by qPCR
- Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry
- Quantitation of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]Quantitation of genetically engineered T-cells in PBMCs by flow cytometry
- Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by qPCR
- Invitro diagnostic (IVD) assay for screening [ Time Frame: 2.5 years ]Development and validation of the MAGE-A4 antigen expression companion diagnostic assay
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|Ages Eligible for Study:||10 Years to 75 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria
- Age ≥16 (10 years at selected sites) and <=75 years
- Diagnosis of advanced synovial sarcoma (Cohort 1 and Cohort 2) or myxoid liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by cytogenetics.
- Previously received either an anthracycline or ifosfamide containing regimen.
- Measurable disease according to RECIST v1.1.
- HLA-A*02 positive
- Tumor shows MAGE-A4 expression confirmed by central laboratory.
- ECOG Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old:
Lansky Score ≥60%.
• Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key Exclusion Criteria:
- HLA-A*02:05 in either allele
- 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 autoimmune or immune mediated disease
- Symptomatic CNS metastases including leptomeningeal disease.
- Other prior malignancy that is not considered by the Investigator to be in complete remission
- Clinically significant cardiovascular disease
- Uncontrolled intercurrent illness
- Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
- Pregnant or breastfeeding
Note: other protocol defined Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044768
|Contact: Adaptimmune Patient Enquiriesemail@example.com|
|Principal Investigator:||Deijka Aruajo, MD||MD Anderson Cancer Center; Houston TX 77030|
|Other Study ID Numbers:||
|First Posted:||August 5, 2019 Key Record Dates|
|Last Update Posted:||December 9, 2022|
|Last Verified:||December 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
T Cell Therapy
SPEAR T Cell
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue