TC-510 Cell Therapy for Cancer

Not currently recruiting at 8 trial locations

Overseen By TCR2 Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: TCR2 Therapeutics

Disqualifiers: Non-compliance, Drug or alcohol use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy called TC-510 for certain types of cancer. TC-510 uses modified T cells (a type of immune cell) to target and fight cancer cells in the body. The trial focuses on cancers such as mesothelioma, ovarian, pancreatic, breast, and colorectal cancers. It is designed for patients whose tumors have a specific protein called Mesothelin and who have already tried other treatments but still need help. Participants should be prepared for a procedure to collect cells and must have undergone at least one previous treatment for their cancer. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that TC-510 cell therapy is likely to be safe for humans?

Research has shown that cell therapies like TC-510 offer a promising new approach to treating cancer. TC-510 uses the body's own T cells, a type of white blood cell, to combat cancer. These T cells are specially modified to better target cancer cells.

Regarding safety, specific data on TC-510 remains limited. However, similar treatments have demonstrated potential safety for patients. For example, studies on other cell therapies, such as anti-CD30 CAR-T cells, have indicated effectiveness and safety for certain cancer types.

TC-510 is still in early testing, so researchers are closely monitoring its safety. While detailed safety information is not yet available, this phase aims to identify any possible side effects before proceeding to larger trials. Prospective trial participants should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments that typically involve chemotherapy, radiation, or surgery, TC-510 is a cell therapy that offers a new approach by using modified T cells to target cancer cells directly. Researchers are excited about TC-510 because it involves lymphodepletion followed by the infusion of TC-510 T cells, which are engineered to enhance the immune system's ability to recognize and attack cancer cells. This innovative mechanism of action has the potential to provide a more precise and powerful treatment, potentially leading to better outcomes for patients with fewer side effects than traditional therapies.

What evidence suggests that TC-510 might be an effective treatment for cancer?

Research shows that TC-510, a new type of cell therapy, might effectively target cancer cells. In lab studies, TC-510 lasted longer and remained active when encountering tumor cells with specific markers, MSLN and PD-L1. This suggests it could continue fighting cancer cells over time. Other T-cell therapies have successfully treated various cancers, with response rates ranging from 35.7% to 66.7%. Early data from similar treatments also show promising results, with some patients experiencing a 30% or more reduction in tumor size. These findings suggest that TC-510 could be a strong option for treating cancers like mesothelioma and ovarian cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain advanced cancers (like mesothelioma, ovarian, pancreatic, colorectal, or triple-negative breast cancer) that express a protein called Mesothelin. Participants should be relatively healthy (ECOG status 0 or 1), have good organ function and no more than five prior systemic therapies for their cancer. They must also be suitable for leukapheresis—a procedure to collect white blood cells.

Inclusion Criteria

I am over 18 years old.

I am fit for a procedure to collect white blood cells and have good vein access.

I have been diagnosed with a specific type of cancer such as MPM, ovarian, pancreatic, TNBC, or colorectal.

Exclusion Criteria

You are known or suspected to not follow the study rules, or use drugs or alcohol.

Inability to follow the procedures of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion

Participants undergo lymphodepletion with fludarabine and cyclophosphamide before receiving TC-510 T cells

1-2 weeks

Treatment

Participants receive TC-510 T cells, a novel cell therapy targeting Mesothelin-expressing cancer

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• TC-510

Trial Overview The trial tests TC-510 cell therapy in patients with Mesothelin-expressing cancers. It involves modifying the patient's T cells to target cancer cells better using two synthetic constructs: one that recognizes Mesothelin and another that turns off immune suppression signals from tumors.

How Is the Trial Designed?

Group I: Lymphodepletion followed by TC-510 Experimental Treatment 3 Interventions

Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells

Who Is Running the Clinical Trial?

TCR2 Therapeutics

Lead Sponsor

Trials

3

Recruited

50+

Published Research Related to This Trial

TCR-T cell therapy shows great promise for treating solid tumors by recognizing a wider range of target antigens compared to CAR-T cells, which are primarily effective against CD19+ B cell-derived cancers.

Currently, there are 56 clinical trials worldwide investigating the efficacy of TCR-T cell therapy, highlighting the growing interest and potential for this approach in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer immunotherapy with lymphocytes genetically engineered with T cell receptors for solid cancers. Chen, L., Qiao, D., Wang, J., et al.[2020]

CAR T-cell therapy targets specific cancer cells while minimizing damage to normal cells, showing promising results in treating acute myeloid leukemia and various solid tumors like pancreatic and ovarian cancers.

Despite its effectiveness, CAR T-cell therapy can cause adverse effects such as cytokine release syndrome and off-target toxicity, highlighting the need for ongoing improvements in safety and efficacy through innovations like SUPRA CAR technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric Antigen Receptor T-cell Therapy in Cancer: A Critical Review. Sharma, R., Suravarjhula, L., Banerjee, M., et al.[2023]

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]

A systematic review of 109 papers identified only 11 studies that utilized patient-reported outcomes (PROs) in adoptive cell therapy (ACT) for cancer, highlighting a lack of ACT-specific PRO measures.

The most commonly used PROs were the PROMIS-29 and EQ-5D, but there is a need for more tailored instruments and research on optimal timing for PRO assessments to better capture patient experiences during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome (PRO) instruments used in patients undergoing adoptive cell therapy (ACT) for the treatment of cancer: a systematic review. Taylor, S., Law, K., Coomber-Moore, J., et al.[2023]

A phase 1 clinical trial of T cell therapy targeting HPV-16 E7 showed promising results, with 6 out of 12 patients experiencing significant tumor regression, including 4 patients who had previously not responded to anti-PD-1 treatment.

The study indicates that engineered T cells can effectively target and reduce tumors in epithelial cancers, but also highlights challenges such as resistance mechanisms that may limit the effectiveness of this therapy in some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TCR-engineered T cells targeting E7 for patients with metastatic HPV-associated epithelial cancers. Nagarsheth, NB., Norberg, SM., Sinkoe, AL., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10700406/

Functional enhancement of mesothelin-targeted TRuC-T ... In vitro, TC-510 showed significant improvements in persistence and resistance to exhaustion upon chronic stimulation by tumor cells expressing MSLN and PD-L1 ...

2. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1487782/full

Clinical advances and challenges associated with TCR-T ... Results: Analysis of 174 eligible clinical trials revealed that TCR-T cell therapy exhibits significant efficacy across various tumor types, ...

3. ccr.cancer.gov ccr.cancer.gov/news/article/new-t-cell-therapy-shrinks-solid-tumors-in-early-phase-clinical-trial

New T-cell therapy shrinks solid tumors in early-phase clinical ... Twenty percent of the 30 patients who received gavo-cel and were evaluable for tumor response experienced a 30% or greater reduction in tumor ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT05451849

A Phase 1/2 Trial of TC-510 In Patients With Advanced ... "The Phase 1/2 clinical trial for TC-510 for people with MPM, ovarian cancer, pancreatic cancer, colorectal cancer, or triple negative breast cancer is ongoing ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493697/

Clinical advances and challenges associated with TCR-T ... The favorable response rates observed in these trials ranged from 35.7% to 66.7%, highlighting the importance of continued exploration of CTAG1B ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03600883

NCT03600883 | A Phase 1/2, Study Evaluating the Safety, ... Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13400-5

Safety and efficacy of anti-CD30 CAR-T cell therapy in ... Current evidence suggests that anti-CD30 CAR-T cell therapy is effective and safe in treating R/R cHL and is worth considering as a viable therapeutic option.

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05451849

TC-510 In Patients With Advanced Mesothelin-Expressing ... TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs.