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CAR T-cell Therapy

Modified TIL Cell Therapy for Sarcoma

Phase 1

Waitlist Available

Led By Neeta Somaiah, MBBS

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥ 12 years old

Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma scheduled to undergo resection or biopsy as part of standard of care

Must not have

History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis

Active concurrent second malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine the right amount of attIL2-TIL cell therapy for patients with sarcomas that have returned or spread. They will also test if this dose can help in controlling the

Who is the study for?

This trial is for people aged 12 and older with advanced or metastatic soft tissue or bone sarcoma, who have had at least one prior systemic therapy unless no standard treatment exists. Participants must be willing to use birth control and have adequate organ function. Pregnant women, those with certain health conditions like uncontrolled illnesses, a history of primary immunodeficiency, active infections, or autoimmune diseases are excluded.

What is being tested?

The study is testing the safety and effectiveness of attIL12-TIL cell therapy in patients with relapsed or metastatic sarcomas. It aims to determine an optimal dose that can manage liposarcoma growth. The trial includes pre-treatment with cyclophosphamide before administering the TIL cell therapy.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue, issues from cyclophosphamide like nausea and low blood counts, as well as site-specific responses where cells are administered.

Eligibility Criteria

Inclusion Criteria

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

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I am 12 years old or older.

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My sarcoma is advanced and I am scheduled for surgery or biopsy.

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My liposarcoma cannot be removed and is recurring or has spread, but I am scheduled for surgery or biopsy.

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I agree to use effective birth control methods during and up to 3 months after the study.

Exclusion Criteria

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

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I have had a primary immunodeficiency, organ transplant, or tuberculosis.

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I have another active cancer besides the one being treated.

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I am allergic to cyclophosphamide or drugs used in this study.

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I do not have any serious ongoing illnesses that would affect my participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 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

Safety and adverse events (AEs)

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: Part BExperimental Treatment2 Interventions

Participants enrolled in Part B, will receive attIL2-TIL cell therapy at the recommended dose that was found in Part A.

Group II: Part A,Experimental Treatment2 Interventions

Participants enrolled in Part A, the dose of attIL2-TIL cell therapy a participant receive will depend on when the participant joins this study. The first group of participants will receive the lowest dose level of attIL2-TIL cell therapy. Each new group will receive a higher dose of attIL2-TIL cell therapy than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of attIL2-TIL cell therapy is found.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

0 / 8Eligibility criteria met