SPEARHEAD-3 Pediatric Study

Study Purpose

This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A*02 eligible and MAGE-A4 positive subjects aged 2-21 years of age with advanced cancers

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 2-21 years.
  • - Body weight ≥ 10 kg.
  • - Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma, (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma.
  • - Must have previously received a systemic chemotherapy.
  • - Measurable disease according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only).
  • - HLA-A*02 positive.
  • - Tumor shows MAGE-A4 expression confirmed by central laboratory.
  • - Performance Status: ECOG 0-1 or Lansky Score ≥ 80.

Exclusion Criteria:

  • - HLA-A*02:05 in either allele; or any A*02 having same protein sequence as HLA-A*02:05.
  • - History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide.
  • - History of autoimmune or immune mediated disease.
  • - Known central nervous system (CNS) metastases.
  • - Other prior malignancy that is not considered by the Investigator to be in complete remission.
  • - Clinically significant cardiovascular disease.
  • - Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus.
- Pregnant or breastfeeding

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05642455
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Adaptimmune
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Fiorella Iglesias Cardenas, MD
Principal Investigator Affiliation Memorial Sloan Kettering Kids
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma, Osteosarcoma
Arms & Interventions

Arms

Experimental: Afamitresgene autoleucel

Interventions

Genetic: - Afamitresgene autoleucel

Single infusion of afamitresgene autoleucel Dose: For subjects ≥10 kg to <40 kg: starting dose of 0.025 - 0.200 x 10'9 transduced cells/kg. For subjects ≥40 kg 1.0x109 to 10x109 transduced by a single intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Palo Alto, California

Status

Not yet recruiting

Address

Stanford University

Palo Alto, California, 94305

Site Contact

[email protected]

University of Colorado, Aurora, Colorado

Status

Not yet recruiting

Address

University of Colorado

Aurora, Colorado, 80045,

National Institue of Health, Bethesda, Maryland

Status

Not yet recruiting

Address

National Institue of Health

Bethesda, Maryland, 80292

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Not yet recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 10065

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63110

Site Contact

Tina Primeau, BA

[email protected]

314-454-2147

Memorial Sloan Kettering Kids, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Kids

New York, New York, 10065

Site Contact

Fiorella Iglesias Cardenas, MD

[email protected]

212-639-6649

Duke University School of Medicine, Durham, North Carolina

Status

Not yet recruiting

Address

Duke University School of Medicine

Durham, North Carolina, 27710

Site Contact

Kris Mahadeo, MD

[email protected]

919-668-1180

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Brian Turpin, DO

[email protected]

513-636-2799

Children's Hospital of Philedephia, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Children's Hospital of Philedephia

Philadelphia, Pennsylvania, 19104

Site Contact

Shelby Brizzolara-Dove, BS

[email protected]

267-425-5544

Seattle Children's Hospital, Seattle, Washington

Status

Not yet recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

University of Wisconsin Cancer Center, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Cancer Center

Madison, Wisconsin, 53715

Site Contact

Jenny Weiland, BS

[email protected]

608-890-8070

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