Synovial SarcomaNCT06617572
Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
A study testing Non-conforming afamitresgene autoleucel in people with Synovial Sarcoma and Myxoid Liposarcoma, run by USWM CT, LLC at 11 sites in United States.
Trial summary
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Synovial Sarcoma, Myxoid Liposarcoma
- What is being tested?
- Non-conforming afamitresgene autoleucel
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 11 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient must provide written informed consent prior to participating in this protocol
- Patient must have been prescribed TECELRA®
- Patient's commercially manufactured product does not meet the commercial release specification
- Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with per consultation with USWM CT
- Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment
- The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient
- Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment
- Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy
Who cannot join
- Patient has contraindication(s) as per the TECELRA® USPI
- Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A*02:05P
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
- Available
Massachusetts General Hospital
Boston, Massachusetts, 02144
Edwin Choy, MD
- Available
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Michael Wagner, MD
- Available
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60601
Seth Pollack, MD
- Available
MD Anderson Cancer Center
Houston, Texas, 77030
Dejka Araujo, MD
- Available
Mayo Florida
Jacksonville, Florida, 32224
Steven Attia, MD
- Available
Memorial Sloan Kettering Cancer Centre
New York, New York, 10065
Sandra D Angelo, MD
- Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Henry Fung, MD
- Available
Mayo Arizona
Phoenix, Arizona, 85259
Mahesh Seetharam, MD
- Available
Mayo Rochester
Rochester, Minnesota, 55905
Steven Robinson, MD
- Available
Stanford Hospital and Clinics
Stanford, California, 94305
Kristen Ganjoo, MD
- Available
Moffit Cancer Center
Tampa, Florida, 33612
Mihaela Druta, MD
About this study
Official title: Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
- Conditions
- Synovial Sarcoma, Myxoid Liposarcoma
- Being tested
- Non-conforming afamitresgene autoleucel
- Medical subject headings
- Sarcoma, Synovial, Liposarcoma, Myxoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-conforming afamitresgene autoleucelGenetic
Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synovial SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- USWM CT, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617572
- Sponsor's protocol ID
- ADP-0044-999
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
- ClinicalTrials.gov ID
- NCT06617572
- Acronym / sponsor ID
- ADP-0044-999
- Conditions
- Synovial Sarcoma, Myxoid Liposarcoma
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- USWM CT, LLCIndustry (pharma, biotech, devices)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient must provide written informed consent prior to participating in this protocol
- Patient must have been prescribed TECELRA®
- Patient's commercially manufactured product does not meet the commercial release specification
- Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with per consultation with USWM CT
- Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment
Key exclusion criteria (2 listed)
- Patient has contraindication(s) as per the TECELRA® USPI
- Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A*02:05P
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-conforming afamitresgene autoleucelNon-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration | Genetic | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-conforming afamitresgene autoleucel in people with Synovial Sarcoma and Myxoid Liposarcoma, run by USWM CT, LLC at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Scientist (866-750-8796, francine.brophy@usworldmeds.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.