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CAR T-cell Therapy

Afamitresgene Autoleucel for Sarcoma

Phase 2
Recruiting
Led By Deijka Aruajo, 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
Must not have
Symptomatic CNS metastases including leptomeningeal disease
Uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases causing symptoms.
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I do not have any unmanaged ongoing illnesses.
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I do not have an active infection with HIV, hepatitis B, hepatitis C, or HTLV.
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I have the HLA-A*02:05 gene.
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I have a serious heart condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy: Overall Response Rate (ORR)
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
24 Previous Clinical Trials
10,867 Total Patients Enrolled
Deijka Aruajo, MDPrincipal InvestigatorMD Anderson Cancer Center; Houston TX 77030
Dejka Araujo, MDPrincipal InvestigatorMD Anderson Cancer Center; Houston TX 77030
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

afamitresgene autoleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04044768 — Phase 2
Soft tissue tumor Research Study Groups: Autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) SPEAR™ T cells
Soft tissue tumor 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
~19 spots leftby Dec 2025
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