Adoptive Cell Therapy for Cancer

Recruiting at 53 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on the long-term safety of a cancer treatment called adoptive cell therapy. It targets individuals who have already received at least one dose of this therapy, which uses modified cells to help the body fight cancer. The trial monitors participants for up to 15 years after their last infusion to ensure the treatment remains safe over time. Those who completed a previous study involving this therapy or accessed it through a special program are well-suited for this trial. Participants must be able to give consent and adhere to local contraception guidelines. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the chance to contribute to pioneering cancer treatment research.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies on GSK adoptive cell therapy have identified some safety concerns, but these have been manageable. For instance, one study found that 50% of patients experienced cytokine release syndrome, but all cases were successfully treated. This indicates that while risks exist, proper care can control them. Other research showed that out of 25 patients, more than half did not experience disease progression after one year, suggesting a good balance between safety and effectiveness. Overall, while side effects require attention, the therapy has generally been well-tolerated with correct management. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about GSK adoptive cell therapy because it offers a new approach to treating cancer by using the patient's own immune cells to fight the disease. Unlike traditional treatments like chemotherapy or radiation, which can damage healthy cells along with cancer cells, this therapy specifically targets and attacks cancer cells. The therapy involves extracting and modifying the patient's T-cells to enhance their cancer-fighting abilities before reintroducing them into the body. This targeted approach has the potential to improve effectiveness and reduce side effects, making it a promising option for cancer patients.

What evidence suggests that this treatment might be an effective treatment for cancer?

Research has shown that GSK's adoptive cell therapy, which participants in this trial will receive, holds promise in fighting cancer. Studies have found that these altered T-cells can continuously produce cells that attack cancer over time. In one study, patients' cancer did not worsen for an average of 13.5 months. Another study found that patients lived for an average of 35.1 months after treatment. This therapy targets NY-ESO-1, a protein found in some tumors, making it a hopeful approach for certain cancers. ^{2 6 7 8 9}

Who Is on the Research Team?

Adaptimmune

Principal Investigator

Adaptimmune

Are You a Good Fit for This Trial?

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

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

I am able to understand and sign the consent form.

Exclusion Criteria

N/A

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31651363/

Systemic and local immunity following adoptive transfer of NY ... These studies address the immunological mechanisms of response and resistance in patients with SS treated with NY-ESO-1 SPEAR T-cells.

2. gsk.com gsk.com/en-gb/media/press-releases/gsk-and-adaptimmune-complete-transition-of-ny-eso-spear-t-cell-therapy-programme-to-gsk/

GSK and Adaptimmune complete transition of NY-ESO ... GSK '794 is an engineered T-cell therapy, for which a patient's own cells have been genetically modified to express a T-cell receptor (TCR) recognising with ...

3. adaptimmune.com adaptimmune.com/investors-and-media/news-center/press-releases/detail/51/study-published-in-cancer-discovery-indicates-that-ny-eso

Study published in Cancer Discovery Indicates that NY ... Data indicate that self-renewing pools of SPEAR T-cells can produce a continuous supply of effector cells capable of mediating sustained ...

4. ashpublications.org ashpublications.org/bloodadvances/article/3/13/2022/246633/Long-term-safety-and-activity-of-NY-ESO-1-SPEAR-T

Long‐term safety and activity of NY-ESO‐1 SPEAR T cells ... Median progression-free survival was 13.5 months (range, 3.2-60.6 months); median overall survival was 35.1 months (range, 6.4-66.7 months).

5. aacrjournals.org aacrjournals.org/clincancerres/article/29/24/5069/731661/Safety-and-Efficacy-of-NY-ESO-1-Antigen-Specific-T

Safety and Efficacy of NY-ESO-1 Antigen-Specific T-Cell ... Conclusions: Adoptive immunotherapy with TBI-1301 to selectively target NY-ESO-1-positive tumor cells appears to be a promising strategy for the treatment of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6616263/

Long‐term safety and activity of NY-ESO‐1 SPEAR T cells ... At year 1, 13/25 patients were disease progression-free (52%); 11 were responders (1 stringent complete response, 1 complete response, 8 very ...

7. jitc.biomedcentral.com jitc.biomedcentral.com/articles/10.1186/s40425-019-0762-2

Systemic and local immunity following adoptive transfer of NY ... Adoptive T-cell therapy using engineered receptors has shown great promise in the treatment of hematologic malignancies, as demonstrated by ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11788651/

Safety and Tolerability of Letetresgene Autoleucel ... The study aims to evaluate the safety, tolerability, and antitumor response of letetresgene autoleucel (lete-cel), genetically modified autologous T cells.

9. adaptimmune.com adaptimmune.com/investors-and-media/news-center/press-releases/detail/108/adaptimmune-presents-preclinical-data-from-a-new

Press Releases NY-ESO SPEAR T-cells have shown promising activity in clinical trials for both solid and liquid tumors. However, the depth and durability of ...