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CAR T-cell Therapy

Genetically Modified T-Cell Therapy for Gastrointestinal Cancer

Phase 1 & 2

Recruiting

Led By James C Yang, 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

- Patients with pancreatic cancer must have received gemcitabine, 5FU, and oxaliplatin (or similar agents), or have contraindications to receiving those medications.

Age greater than or equal to 18 years and less than or equal to 72 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Awards & highlights

Study Summary

This trial is testing a new cancer therapy that takes white blood cells from a person, grows them in a lab, genetically changes them, then gives them back to the person. The aim is to see if the therapy is safe and causes tumors to shrink.

Who is the study for?

Adults aged 18-72 with certain advanced cancers (like colorectal, pancreatic, stomach) that haven't responded to standard treatments or who have declined them. They must not be pregnant, HIV positive, or have hepatitis B/C. Participants need functioning major organs and no severe immune deficiencies or allergies to the trial drugs.Check my eligibility

What is being tested?

The trial is testing a new therapy where patients' white blood cells are modified in a lab to target cancer cells with a specific mutation (G12D variant of mutated RAS). Patients will receive chemotherapy and then their engineered cells back via IV along with other supportive medications over several weeks.See study design

What are the potential side effects?

Possible side effects include reactions from the gene transfer process, effects from chemotherapy like nausea and hair loss, increased risk of infection due to immune system suppression by the treatment regimen, fatigue, and potential organ inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I have pancreatic cancer and have been treated with or cannot take gemcitabine, 5FU, and oxaliplatin.

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I am between 18 and 72 years old.

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My advanced cancer did not respond to or has returned after standard treatment.

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I have colorectal cancer and have tried at least two chemotherapy treatments or cannot take them due to health reasons.

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I have had the first round of approved chemotherapy for my ovarian or prostate cancer.

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I do not have HIV.

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My white blood cell count is healthy without needing medication.

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I have finished all my previous cancer treatments.

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I am HLA-A*11:01 positive as confirmed by testing.

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My white blood cell count is healthy without needing medication.

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

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I do not have HIV.

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My cancer is advanced, can't be removed by surgery, and has a specific KRAS mutation.

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I am between 18 and 70 years old.

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I am fully active or can carry out light work.

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I have chosen not to undergo standard treatment.

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I have NSCLC and received treatment based on my cancer's specific genetic features or had platinum-based chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 12 weeks following administration of the cell product, 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 weeks and 12 weeks following administration of the cell product, 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

Frequency and severity of treatment-related adverse events

Response rate

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/Phase IIExperimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MTD of anti-KRAS G12D mTCR PBL + high-dose aldesleukin

Group II: 1/Phase IExperimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + escalating doses of anti-KRAS G12D mTCR PBL + highdose aldesleukin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Aldesleukin

2012

Completed Phase 4

~1620

Fludarabine

2012

Completed Phase 3

~1100

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,611 Total Patients Enrolled

James C Yang, M.D.Principal InvestigatorNational Cancer Institute (NCI)

6 Previous Clinical Trials

462 Total Patients Enrolled

Media Library

anti-KRAS G12D mTCR PBL (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03745326 — Phase 1 & 2

Gastrointestinal Cancer Research Study Groups: 1/Phase I, 2/Phase II

Gastrointestinal Cancer Clinical Trial 2023: anti-KRAS G12D mTCR PBL Highlights & Side Effects. Trial Name: NCT03745326 — Phase 1 & 2

anti-KRAS G12D mTCR PBL (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03745326 — Phase 1 & 2

Frequently Asked Questions

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

Are new applicants being considered for this experiment?

"Affirmative. According to information published on clinicaltrials.gov, this study is actively recruiting patients as of October 4th 2022 - with the initial posting made in May 16th 2019 . There are 70 slots available at a single site for potential participants."

Answered by AI

What is the upper threshold of participants in this experiment?

"Affirmative. According to the details present on clinicaltrials.gov, this medical study is actively recruiting participants and was originally posted on May 16th 2019 with a recent edit made October 4th 2022. 70 subjects are sought after at 1 centre."

Answered by AI

To whom is this investigation open for participation?

"This clinical trial is enlisting 70 individuals, aged 18 to 70 years old with colonic malignancy. Moreover, enrollees must conform to the following criteria: Patients having metastasized colorectal cancer ought to have gone through two systemic chemotherapeutic regimens including 5FU, leucovorin, bevacizumab and oxaliplatin or similar medications; contrarily they should demonstrate contraindication for them., For pancreatic cancer patients gemcitabine plus 5FU and oxaliplatin (or related agents) are mandatory unless there's a counter-indication against such remedies"

Answered by AI

Does the research team accept participants aged forty and above?

"Pursuant to the trial's enrollment prerequisites, patients must fall within a minimum age of 18 and maximum age of 70 in order to be considered."

Answered by AI

What other research has been done into the efficacy of anti-KRAS G12D mTCR PBL?

"Currently, there are 913 ongoing trials for anti-KRAS G12D mTCR PBL with 163 of those in the final stage. Most studies are running out of Philadelphia, Pennsylvania however 28673 locations globally have active trials related to this research topic."

Answered by AI

To what ailment is anti-KRAS G12D mTCR PBL routinely utilized to treat?

"Anti-KRAS G12D mTCR PBL has been observed to be an effective therapy for multiple sclerosis, myelocytic leukemia, acute retinoblastoma and other illnesses."

Answered by AI