← Back to Search

CAR T-cell Therapy

TCR-T Cell Therapy for Cancer

Q: Has the FDA sanctioned KK-LC-1 TCR-T cells for clinical usage?

As this is an initial phase 1 trial, the KK-LC-1 TCR-T cells are deemed to have a safety score of 1 due to the limited amount of clinical data supporting its efficacy and security.

Q: Is there still capacity available for participants in this medical trial?

Evidenced by the most recent update (dated September 26th 2022) on clinicaltrials.gov, this medical trial is seeking participants who meet its criteria. It was first posted to the site on that same date.

Q: What is the enrollment maximum for this experiment?

Yes, the evidence on clinicaltrials.gov affirms that this medical study is actively searching for participants. It was first uploaded on September 26th 2022 and updated recently with a goal of recruiting 42 patients from one site.

Phase 1

Recruiting

Led By Christian S Hinrichs, MD

Research Sponsored by Christian Hinrichs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with < 3 brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 5 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving TCR-T cells. Participants will receive infusions of the cells, as well as aldesleukin, and doctors will monitor for safety and effectiveness.

Who is the study for?

This trial is for adults over 18 with metastatic gastric, breast, cervical, or lung cancer that tests positive for KK-LC-1. They must have tried standard treatments without success and be in good physical condition (ECOG 0 or 1). Participants need functioning organs/marrow and no active infections like HIV or hepatitis. Pregnant women can't join, and those who can bear children must use contraception.Check my eligibility

What is being tested?

The trial is testing the safety and maximum dose of KK-LC-1 TCR-T cells combined with aldesleukin in treating certain cancers. It's a phase I study to see how patients tolerate this treatment and what their clinical response will be after receiving a conditioning regimen followed by the therapy.See study design

What are the potential side effects?

Possible side effects may include reactions related to immune cell infusion such as fever, fatigue, chills; organ inflammation due to immune response; issues from high-dose aldesleukin including low blood pressure, fluid buildup; plus general risks associated with cancer immunotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have up to 3 brain metastases treated with surgery or radiosurgery and stable for 1 month.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My organ and bone marrow functions are within normal ranges.

Select...

It's been over 4 weeks since my last cancer treatment and any side effects are mild or stable.

Select...

I am older than 18 years.

Select...

My cancer is advanced and tests positive for KK-LC-1 in at least 25% of cells.

Select...

My genetic test shows I have the HLA-A*01:01 allele.

Select...

My heart pumps well, confirmed by a heart scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

T-Cell Receptor

Secondary outcome measures

Adverse events of KK-LC-1 TCR T cells

Tumor response duration

Tumor response rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: KK-LC-1 TCR-T cellsExperimental Treatment2 Interventions

Subjects will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Christian HinrichsLead Sponsor

2 Previous Clinical Trials

35 Total Patients Enrolled

Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute of New JerseyUNKNOWN

T Cure BioscienceUNKNOWN

Media Library

KK-LC-1 TCR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05483491 — Phase 1

Stomach Cancer Research Study Groups: KK-LC-1 TCR-T cells

Stomach Cancer Clinical Trial 2023: KK-LC-1 TCR-T cells Highlights & Side Effects. Trial Name: NCT05483491 — Phase 1

KK-LC-1 TCR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05483491 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned KK-LC-1 TCR-T cells for clinical usage?

"As this is an initial phase 1 trial, the KK-LC-1 TCR-T cells are deemed to have a safety score of 1 due to the limited amount of clinical data supporting its efficacy and security."

Answered by AI

Is there still capacity available for participants in this medical trial?

"Evidenced by the most recent update (dated September 26th 2022) on clinicaltrials.gov, this medical trial is seeking participants who meet its criteria. It was first posted to the site on that same date."

Answered by AI

What is the enrollment maximum for this experiment?

"Yes, the evidence on clinicaltrials.gov affirms that this medical study is actively searching for participants. It was first uploaded on September 26th 2022 and updated recently with a goal of recruiting 42 patients from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

Christian Hinrichs 2022. "KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05483491.

All > No Stomach For Cancer > Cervical Cancer