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CAR T-cell Therapy

NK Cell Therapy + Chemotherapy for Sarcoma

Phase 1

Recruiting

Led By John Livingston, MD

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

Patients with all cancer histology, with an HLA-A*02:01, HLA-A*02:05 or HLA-A*02:06 positive and a positive expression of NY-ESO-1 (>/= 50% tumor cells 2+ or 3+ by IHC) in the preenrollment tumor sample, for the dose escalation cohort. NY-ESO expression must be confirmed at MDACC prior to study entry.

Patients with histologically confirmed synovial sarcoma (cohort 1) or myxoid/round cell liposarcoma (cohort 2), with an HLA-A*02:01, HLA-A*02:05 or HLA-A*02:06 positive and a positive expression of NY-ESO-1 (>/= 50% tumor cells 2+ or 3+ by IHC) in the pre-enrollment tumor sample, for the expansion cohorts. Archival samples will be permitted for screening. NY-ESO expression must be confirmed at MDACC prior to study entry.

Must not have

Presence of active neurological disorder(s).

- New York Heart Association Class III or IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate a donated immune cell therapy to treat advanced cancer with chemo, testing safety and dosing.

Who is the study for?

This trial is for people aged 16-80 with advanced sarcomas, specifically synovial or myxoid/round cell liposarcoma, who've tried at least one standard treatment without success. They must have proper liver, kidney, heart, and blood function and no serious infections or autoimmune diseases. Participants need to be HLA-A*02 positive with NY-ESO-1 expression in tumors.

What is being tested?

The study tests the safety and optimal dose of donated NK cells expressing a TCR against NY-ESO-1 combined with chemotherapy (Cyclophosphamide and Fludarabine phosphate) in patients with specific advanced cancers to see how well they tolerate it and its effects on their disease.

What are the potential side effects?

Potential side effects include reactions from the immune system such as inflammation in various organs due to the engineered NK cells; chemotherapy may cause nausea, hair loss, fatigue, increased risk of infection, bleeding disorders among other common chemo-related side effects.

Eligibility Criteria

Inclusion Criteria

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

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My cancer expresses NY-ESO-1 and I have specific HLA types.

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My cancer is either synovial sarcoma or myxoid/round cell liposarcoma, tests positive for specific HLA types, and shows high NY-ESO-1 expression.

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My cancer returned or didn't respond after standard treatment, including specific drugs.

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My kidney function is within the required range.

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My cancer is a specific type of liposarcoma confirmed by genetic testing.

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My liver function tests are within the required range and I don't have liver cirrhosis or ascites.

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I am between 16 and 80 years old.

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I weigh at least 40 kg.

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My condition is myxoid/round cell liposarcoma.

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My sarcoma diagnosis was confirmed with a specific genetic test.

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I am fully active or can carry out light work.

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My blood clotting tests are within normal limits.

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I will use effective birth control 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 an active neurological disorder.

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I have severe heart failure.

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I have been diagnosed with severe narrowing of my heart's aortic valve.

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I have an active hepatitis B or C infection.

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I have been diagnosed with amyloidosis or POEMS syndrome.

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I do not have uncontrolled brain symptoms or spinal cord compression.

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I have HIV with a detectable viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Dose escalation - Inpatient and OutpatientExperimental Treatment3 Interventions

Participants will be assigned to receive a dose level of NK cells based on when the participants joins the study. Up to 6 participants will be enrolled at each dose level. If no intolerable side effects are seen after the first 3-6, the next group of participants will get at higher dose. Up to 4 dose levels of NK cells will be tested. If the first dosing group shows intolerable side effects, a lower dose will be tested.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine phosphate

2007

Completed Phase 2

~370

Cyclophosphamide

2010

Completed Phase 4

~2310