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CAR T-cell Therapy

Armed Activated T-Cells for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Kenneth Yu, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Must have metastatic pancreatic cancer and have received at least first-line chemotherapy

Histological or cytological proof of pancreatic adenocarcinoma

Must not have

Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis

Known HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment to see if it is safe and effective for people with advanced pancreatic cancer.

Who is the study for?

This trial is for adults with advanced pancreatic cancer who've had first-line chemo. They should have stable or progressing disease after treatment, good performance status (able to carry out daily activities), and adequate organ function. Pregnant women can't join, nor those breastfeeding or with certain medical conditions that could affect compliance.

What is being tested?

The study tests EGFR-BATs (anti-EGFR-bispecific antibody armed activated T-cells) in patients to determine the safest dose and side effects. Participants must have previously received standard chemotherapy for their condition.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation, such as inflammation in various organs, infusion-related reactions, fatigue, increased risk of infection due to immune response alteration, and possible allergic reactions if sensitive to components like cetuximab.

Eligibility Criteria

Inclusion Criteria

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

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I have pancreatic cancer that has spread and received first-line chemotherapy.

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My diagnosis is pancreatic cancer, confirmed by lab tests.

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I am of childbearing age and have a recent negative pregnancy test.

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I am mostly able to care for myself and perform daily activities.

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My kidney function is within the required range.

Exclusion Criteria

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

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I have an ongoing liver condition like cirrhosis or hepatitis.

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I am HIV positive.

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I have no severe side effects from previous cancer treatments.

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I have brain metastasis causing symptoms.

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I haven't had any serious wounds, surgeries, or injuries in the last 28 days.

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I am currently being treated for an infection.

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I do not have active bleeding or a condition that could cause serious bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluate toxicity

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pancreatic AdenocarcinomaExperimental Treatment1 Intervention

Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.

0 / 12Eligibility criteria met