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CAR T-cell Therapy

Gene Transfer Therapy for Metastatic Cancer

Phase 2

Recruiting

Led By Steven A Rosenberg, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age between 18 and 72 years

Clinical performance status of ECOG 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Awards & highlights

Study Summary

This trial is testing whether gene transfer therapy can shrink tumors in people with metastatic cancer.

Who is the study for?

This trial is for adults aged 18-72 with certain metastatic cancers that haven't responded to standard treatments. Participants must be in good physical condition, not have HIV or hepatitis, agree to use birth control, and sign consent forms. Pregnant women and those with major illnesses or hypersensitivity reactions are excluded.Check my eligibility

What is being tested?

The study tests gene transfer therapy using the patient's own white blood cells engineered to attack cancer mutations. It involves leukapheresis, cell modification in a lab, hospital treatment including drug administration via catheter, recovery period with medications and follow-up visits.See study design

What are the potential side effects?

Potential side effects include reactions from the infusion of modified cells or drugs like Aldesleukin and Pembrolizumab (KEYTRUDA), which may cause immune system complications, infection risks, organ inflammation, fatigue among others based on individual tolerance.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 72 years old.

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

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My cancer has spread and can be measured.

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My cancer did not respond to standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Response rate

Secondary outcome measures

Safety and tolerance

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/iTCR + PembroExperimental Treatment5 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + Individual Patient TCRTransduced PBL + high- or low-dose aldesleukin + pembrolizumab prior to cell administration and 3 additional doses every 3 weeksfollowing cell infusion

Group II: 1/iTCRExperimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + Individual Patient TCR-Transduced PBL + high- or low-dose aldesleukin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aldesleukin

2012

Completed Phase 4

~1620

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,002 Total Patients Enrolled

78 Trials studying Neuroendocrine Tumors

43,353 Patients Enrolled for Neuroendocrine Tumors

Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)

37 Previous Clinical Trials

17,611 Total Patients Enrolled

2 Trials studying Neuroendocrine Tumors

1,332 Patients Enrolled for Neuroendocrine Tumors

Media Library

Individual Patient TCR-Transduced PBL (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03412877 — Phase 2

Neuroendocrine Tumors Research Study Groups: 1/iTCR, 2/iTCR + Pembro

Neuroendocrine Tumors Clinical Trial 2023: Individual Patient TCR-Transduced PBL Highlights & Side Effects. Trial Name: NCT03412877 — Phase 2

Individual Patient TCR-Transduced PBL (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03412877 — Phase 2

Frequently Asked Questions

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

Has the FDA accorded its blessing to Pembrolizumab (KEYTRUDA)?

"Our experts at Power rated Pembrolizumab's safety a 2, as the available data suggests its security but has yet to validate efficacy."

Answered by AI

Are there any prior studies that have utilized Pembrolizumab (KEYTRUDA )?

"Presently, Pembrolizumab (KEYTRUDA ) has 1838 clinical trials underway with 283 of them being in the advanced Phase 3. These studies are largely based in Philadelphia, Pennsylvania yet can be found at 63644 different sites across the globe."

Answered by AI

How many participants are currently being evaluated in this research investigation?

"That is correct. According to information available at clinicaltrials.gov, this experiment commenced recruitment on September 6th 2018 and was last modified on October 19th 2022. At present, it requires the participation of 270 patients from a single location."

Answered by AI

Could I be included among the participants of this research?

"The prerequisites for this medical trial necessitate that participants suffer from neuroendocrine tumors and are aged 18 to 70. The total number of people expected to join is 270."

Answered by AI

Does this research endeavor include individuals aged 75 and older?

"This medical trial can accept participants between 18 and 70 years of age, in accordance with the inclusion criteria."

Answered by AI

Are there any available slots for participating in this research study?

"Confirmed. The clinical trial is indeed seeking participants for enrollment as indicated on the data hosted on clinicaltrials.gov; this study was first introduced on September 6th 2018 and underwent its most recent edit October 19th 2022. 270 patients will be recruited from a single facility."

Answered by AI

To what maladies is Pembrolizumab (KEYTRUDA) typically used as an efficacious remedy?

"Physicians often administer pembrolizumab (KEYTRUDA) to patients with non-Hodgkins lymphoma. This medication has also been known to successfully treat malignant melanoma of the skin, recurrent cervical cancer, and leukemia."

Answered by AI

Recent research and studies

Nature MedicineJournal

Mining Exomic Sequencing Data to Identify Mutated Antigens Recognized by Adoptively Transferred Tumor-reactive T Cells

Robbins, Paul F, Yong-Chen Lu, Mona El-Gamil, Yong F Li, Colin Gross, Jared Gartner, Jimmy C Lin, et al.. 2013. “Mining Exomic Sequencing Data to Identify Mutated Antigens Recognized by Adoptively Transferred Tumor-reactive T Cells”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm.3161.

ScienceJournal

Cancer Immunotherapy Based on Mutation-specific CD4+ T Cells in a Patient with Epithelial Cancer

Tran, Eric, Simon Turcotte, Alena Gros, Paul F. Robbins, Yong-Chen Lu, Mark E. Dudley, John R. Wunderlich, et al.. 2014. “Cancer Immunotherapy Based on Mutation-specific CD4+ T Cells in a Patient with Epithelial Cancer”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1251102.

Clinical Cancer ResearchJournal

Efficient Identification of Mutated Cancer Antigens Recognized by T Cells Associated with Durable Tumor Regressions

Lu, Yong-Chen, Xin Yao, Jessica S. Crystal, Yong F. Li, Mona El-Gamil, Colin Gross, Lindy Davis, et al.. 2014. “Efficient Identification of Mutated Cancer Antigens Recognized by T Cells Associated with Durable Tumor Regressions”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-14-0433.

ScienceJournal