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 2-17 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:

  • - Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).
  • - Age: (A) Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years.
  • - Body weight ≥ 10 kg.
  • - Must have previously received a systemic chemotherapy.
  • - Measurable disease prior to lymphodepletion 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: (A) Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80.
• Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.

Exclusion Criteria:

  • - Positive for 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.
  • - Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.

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 (NBL), 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 5380748, California 5332921

Status

Recruiting

Address

Stanford University

Palo Alto 5380748, California 5332921, 94305

Site Contact

Amy Li

[email protected]

650-788-6811

National Institutes of Health, Bethesda 4348599, Maryland 4361885

Status

Recruiting

Address

National Institutes of Health

Bethesda 4348599, Maryland 4361885, 20892

Site Contact

Kane Kaosaard

[email protected]

301-204-9057

Dana Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Not yet recruiting

Address

Dana Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 10065

Washington University, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Washington University

St Louis 4407066, Missouri 4398678, 63110

Site Contact

Tina Primeau, BA

[email protected]

314-454-2147

Memorial Sloan Kettering Kids, New York 5128581, New York 5128638

Status

Not yet recruiting

Address

Memorial Sloan Kettering Kids

New York 5128581, New York 5128638, 10065

Site Contact

Fiorella Iglesias Cardenas, MD

[email protected]

212-639-6649

Duke University School of Medicine, Durham 4464368, North Carolina 4482348

Status

Not yet recruiting

Address

Duke University School of Medicine

Durham 4464368, North Carolina 4482348, 27710

Site Contact

Kris Mahadeo, MD

[email protected]

919-668-1180

Cincinnati 4508722, Ohio 5165418

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati 4508722, Ohio 5165418, 45229

Site Contact

Brian Turpin, DO

[email protected]

513-636-2799

Children's Hospital of Philedephia, Philadelphia 4560349, Pennsylvania 6254927

Status

Recruiting

Address

Children's Hospital of Philedephia

Philadelphia 4560349, Pennsylvania 6254927, 19104

Site Contact

Shelby Brizzolara-Dove, BS

[email protected]

267-425-5544

Seattle Children's Hospital, Seattle 5809844, Washington 5815135

Status

Not yet recruiting

Address

Seattle Children's Hospital

Seattle 5809844, Washington 5815135, 98105

University of Wisconsin Cancer Center, Madison 5261457, Wisconsin 5279468

Status

Recruiting

Address

University of Wisconsin Cancer Center

Madison 5261457, Wisconsin 5279468, 53715

Site Contact

Jenny Weiland, BS

[email protected]

608-890-8070

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