← Back to Search

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.

Must not have

Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).

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

No Placebo-Only Group

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.

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.

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

Select...

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

Select...

I am between 18 and 72 years old.

Select...

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

Select...

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

Select...

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

Select...

I do not have HIV.

Select...

My white blood cell count is healthy without needing medication.

Select...

I have finished all my previous cancer treatments.

Select...

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

Select...

My white blood cell count is healthy without needing medication.

Select...

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

Select...

I do not have HIV.

Select...

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

Select...

I am between 18 and 70 years old.

Select...

I am fully active or can carry out light work.

Select...

I have chosen not to undergo standard treatment.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any current infections that could weaken my immune system.

Select...

I have a condition that significantly weakens my immune system.

Select...

I am currently on systemic steroid therapy.

Select...

I have had heart surgery or symptoms of reduced blood flow to my heart.

Select...

I do not have any active infections, bleeding disorders, or serious illnesses that are not under control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and severity of treatment-related adverse events

Response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

Aldesleukin

2012

Completed Phase 4

~1610