TC-510 Cell Therapy for Cancer

Recruiting at 7 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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests TC-510, a therapy using a patient's own modified T cells to target and attack cancer cells. It is aimed at patients with cancers that are hard to treat with standard methods. The modified T cells are designed to recognize specific proteins on cancer cells and get an extra boost to kill them.

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.

What data supports the effectiveness of the TC-510 treatment for cancer?

Research shows that adoptive cell therapy, which includes treatments like TC-510, has been effective in treating certain cancers by using genetically engineered T cells to target and destroy cancer cells. Studies have demonstrated significant tumor regression in some patients, indicating potential effectiveness for this type of treatment. ^{1 2 3 4 5}

How is the TC-510 treatment different from other cancer treatments?

TC-510 is a type of adoptive T-cell therapy, which involves genetically engineering T cells to better recognize and attack cancer cells. This approach is unique because it can target a wider range of antigens on solid tumors compared to traditional CAR-T cell therapies, potentially making it more effective for treating solid cancers. ^{4 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gene Augmentation and Editing to Improve TCR Engineered T Cell Therapy against Solid Tumors. [2020]

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

T-cell receptor-based therapy: an innovative therapeutic approach for solid tumors. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Principles of adoptive T cell therapy in cancer. [2020]

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

TCR-engineered T cells targeting E7 for patients with metastatic HPV-associated epithelial cancers. [2023]

6. China pubmed.ncbi.nlm.nih.gov

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

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

The Evolution of T-cell Therapies for Solid Malignancies. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer immunotherapy with lymphocytes genetically engineered with T cell receptors for solid cancers. [2020]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Chimeric Antigen Receptor T-cell Therapy in Cancer: A Critical Review. [2023]