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CAR T-cell Therapy

Afamitresgene Autoleucel for Sarcoma

Phase 2
Recruiting
Led By Dejka Araujo, MD
Research Sponsored by Adaptimmune
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥16 (10 years at selected sites) and <=75 years
Previously received either an anthracycline or ifosfamide containing regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

Study Summary

This trial is studying a new treatment for synovial sarcoma and MRCLS.

Who is the study for?
This trial is for people aged 16-75 with advanced synovial sarcoma or myxoid/round cell liposarcoma, who've had certain chemotherapies. They must have measurable disease, be HLA-A*02 positive without the HLA-A*02:05 allele, and show MAGE-A4 expression. Exclusions include autoimmune diseases, other active cancers, significant heart disease, uncontrolled illnesses, infections like HIV or hepatitis B/C, pregnancy/breastfeeding and allergies to study drugs.Check my eligibility
What is being tested?
The Spearhead 1 Study tests afamitresgene autoleucel (ADP-A2M4) in patients with metastatic or inoperable Synovial Sarcoma or Myxoid/Round Cell Liposarcoma. It's focused on those eligible for HLA-A*02 and positive for MAGE-A4 protein to assess the treatment's effectiveness and safety.See study design
What are the potential side effects?
While specific side effects are not listed here, similar therapies can cause immune reactions due to altered T-cell activity which may lead to inflammation in various organs. There could also be typical chemotherapy-related side effects such as fatigue, nausea and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 16 and 75 years old, or between 10 and 75 at certain locations.
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I have been treated with anthracycline or ifosfamide before.
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I am HLA-A*02 positive.
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I have been diagnosed with advanced synovial sarcoma or myxoid liposarcoma, confirmed by genetic testing.
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I am fully active or can carry out light work.
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My tumor tests positive for MAGE-A4.
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I am between 10 and 16 years old and can do most activities without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response (DoR)
Efficacy: Best overall response (BOR)
Evaluate safety of ADP-A2M4 through measurement of Replication -competent Retrovirus in genetically engineered T-cells
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) SPEAR™ T cellsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor
16 Previous Clinical Trials
10,438 Total Patients Enrolled
2 Trials studying Synovial Sarcoma
91 Patients Enrolled for Synovial Sarcoma
Dejka Araujo, MDPrincipal InvestigatorMD Anderson Cancer Center; Houston TX 77030
1 Previous Clinical Trials
72 Total Patients Enrolled
Deijka Aruajo, MDPrincipal InvestigatorMD Anderson Cancer Center; Houston TX 77030

Media Library

afamitresgene autoleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04044768 — Phase 2
Synovial Sarcoma Research Study Groups: Autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) SPEAR™ T cells
Synovial Sarcoma Clinical Trial 2023: afamitresgene autoleucel Highlights & Side Effects. Trial Name: NCT04044768 — Phase 2
afamitresgene autoleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04044768 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has afamitresgene autoleucel (previously ADP-A2M4) received FDA approval?

"Afamitresgene autoleucel (previously ADP-A2M4) is currently in Phase 2 of clinical trials. While there is evidence suggesting that it is safe, there is no data yet to support its efficacy."

Answered by AI

Where are patients able to enroll in this trial?

"There are presently 19 sites where this clinical trial is enrolling patients. The locations in Toronto, Columbus and New york as well as the other 16 locations. To help reduce participant burden, it is advisable to choose the location nearest you."

Answered by AI

How many people are currently enrolled in this clinical trial?

"The listing on clinicaltrials.gov verifies that this research is still open to new patients. The study was established on 8/13/2019, with the most recent update occurring on 10/5/2022. They are looking for 90 individuals total, which will be drawn from 19 different locations."

Answered by AI

Does this research project restrict volunteers to those under 25 years old?

"The aim of this clinical study is to recruit patients who are over the age of 10 and under the age of 75."

Answered by AI

Can new patients still sign up for this program?

"The study, which was originally published on August 13th 2019 and last updated October 5th 2020, is still recruiting patients."

Answered by AI

How can I sign up to participate in this research?

"This study is investigating a potential treatment for synovial sarcoma and thus patients with this diagnosis are encouraged to apply. The age limit for participants is between 10 and 75 years old, and the team leading the trial hopes to have around 90 people enrolled by the end."

Answered by AI

Who else is applying?

What site did they apply to?
City of Hope
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
~21 spots leftby Mar 2025