Adoptive Cell Therapy for Cancer

Recruiting at 48 trial locations

Overseen By Adaptimmune Patient Enquiries Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Adaptimmune

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial investigator for guidance based on your medical history.

What makes GSK adoptive cell therapy unique compared to other cancer treatments?

GSK adoptive cell therapy is unique because it uses genetically engineered T-cells that specifically target the NY-ESO-1 antigen, which is found in certain cancers like synovial sarcoma and melanoma. This approach allows for precise targeting of cancer cells, potentially leading to better outcomes with fewer side effects compared to traditional treatments. ^{1 2 3 4 5}

Research Team

Adaptimmune

Principal Investigator

Adaptimmune

Eligibility Criteria

This trial is for people who have previously received GSK adoptive cell therapy as a treatment for tumors. They should be able to consent, have finished or withdrawn from a related GSK study, or completed treatment through managed access. Participants must follow local contraception guidelines and have taken at least one dose of the therapy.

Inclusion Criteria

The investigator is responsible for review of medical history

I am able to understand and sign the consent form.

Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ADP adoptive cell therapy

Not specified

Long-term Follow-up

Participants are monitored for safety following last adoptive cell therapy infusion

15 years

Treatment Details

Interventions

• GSK adoptive cell therapy

Trial Overview The trial is monitoring the long-term safety of GSK's adoptive cell therapy in patients up to 15 years after their last infusion. It aims to track any late-emerging side effects and overall health outcomes following the treatment.

Participant Groups

Group I: Participants receiving ADP adoptive cell therapy Experimental Treatment 1 Intervention

GSK adoptive cell therapy is already approved in European Union, United States for the following indications:

Approved in European Union as GSK3377794 for:

• Synovial sarcoma

Approved in United States as GSK3377794 for:

• Synovial sarcoma

Who Is Running the Clinical Trial?

Adaptimmune

Lead Sponsor

Trials

25

Recruited

10,000+

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Adoptive cell therapy using chimeric antigen receptor T cells has been revolutionary for treating blood cancers, but it has not been as effective for solid tumors, highlighting a need for improved strategies.

Recent advancements, such as modified T cell receptors targeting specific tumor-associated antigens and the use of tumor-infiltrating lymphocytes, have shown promise in treating certain solid tumors like synovial sarcoma and metastatic cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive cell therapy for solid tumors: Chimeric antigen receptor T cells and beyond. Moreno, V., Hernandez, T., de Miguel, M., et al.[2021]

Adoptive T-cell therapy involves using tumor-fighting T-cells that are either taken from the patient or donors, modified in the lab, and then reintroduced into the patient to target and eliminate cancer cells.

Over the past 30 years, various strategies have evolved in adoptive T-cell therapy, leading to more precise targeting of tumors and improved effectiveness in treating cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advances in application of adoptive T-cell therapy for cancer patients]. Jixia, Z., Chengyan, Z., Pingli, W.[2023]

Adoptive T-cell therapy is a promising cancer treatment that enhances the body's immune response by using tumor-reactive T cells, which can provide high specificity and long-term protection against tumors.

Recent advancements in understanding T-cell behavior and new technologies have improved the ability to isolate and enhance T cells, making this therapy more effective when combined with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of endogenous T cells for adoptive transfer. Yee, C.[2023]

Cytokine-induced killer cells (CIKs) are effective in targeting and eradicating tumors with minimal side effects, making them a promising option for adoptive cellular immunotherapy in both hematological and solid tumors.

CIKs can be enhanced by dendritic cells (DCs) to improve their antitumor efficacy, and they are particularly beneficial for patients relapsing after allogeneic transplantation or those with hepatic carcinoma post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials with Combination of Cytokine-Induced Killer Cells and Dendritic Cells for Cancer Therapy. Garofano, F., Gonzalez-Carmona, MA., Skowasch, D., et al.[2020]

In a clinical trial involving patients with metastatic melanoma and synovial cell sarcoma, T cells engineered to target the NY-ESO-1 antigen showed promising results, with objective clinical responses in 4 out of 6 patients with synovial cell sarcoma and 5 out of 11 patients with melanoma.

Notably, two melanoma patients achieved complete tumor regressions lasting over a year, highlighting the potential of TCR-based therapies as an effective treatment option for cancers expressing NY-ESO-1.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. Robbins, PF., Morgan, RA., Feldman, SA., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Adoptive cell therapy for solid tumors: Chimeric antigen receptor T cells and beyond. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Advances in application of adoptive T-cell therapy for cancer patients]. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The use of endogenous T cells for adoptive transfer. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Trials with Combination of Cytokine-Induced Killer Cells and Dendritic Cells for Cancer Therapy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. [2023]