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CAR T-cell Therapy

NK Cell Therapy + Chemotherapy for Advanced Kidney, Lung, or Bone Cancer

Phase 1 & 2

Recruiting

Led By David Hong, 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

Eastern Cooperative Oncology Group performance status < 2 (Appendix A)

Patients with advanced clear cell renal cell carcinoma, osteosarcoma or mesothelioma, with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry

Must not have

Active hepatitis B or C. Human immunodeficiency virus with detectable viral load

Symptomatic or uncontrolled central nervous system involvement or signs of cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a therapy of donated NK cells & chemo for advanced kidney, lung, or bone cancer patients to find the best dose.

Who is the study for?

Adults aged 18-80 with advanced renal cell carcinoma, mesothelioma, or osteosarcoma showing CD70 expression can join. They must have proper organ function and agree to birth control use. Exclusions include serious medical conditions, recent heart issues or major surgery, other cancer treatments or investigational drugs within specific time frames.

What is being tested?

The trial is testing the safety and dosage of CAR.70/IL15-transduced CB-derived NK cells combined with lymphodepleting chemotherapy (Fludarabine phosphate and Cyclophosphamide) in patients with certain advanced cancers to see how well they work together.

What are the potential side effects?

Potential side effects may include reactions from the immune system due to infused NK cells, complications from chemotherapy like nausea, fatigue, hair loss, increased infection risk; organ inflammation; and possible infertility.

Eligibility Criteria

Inclusion Criteria

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

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I can do all my daily activities without help.

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My cancer shows high CD70 levels in tests.

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My kidney, liver, heart, lungs, blood, and clotting functions are all within normal ranges.

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I am between 18 and 80 years old.

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I am not pregnant and can become pregnant.

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I weigh at least 40 kg.

Exclusion Criteria

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

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I have active hepatitis B or C, or HIV with a detectable viral load.

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I have symptoms or uncontrolled issues in my brain or spinal cord.

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I am currently fighting an infection that needs IV drugs or isn't getting better with treatment.

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I have been diagnosed with amyloidosis or POEMS syndrome.

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I have an active neurological disorder.

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: Chemotherapy and NK Cell InfusionExperimental Treatment3 Interventions

Participants will be assigned to a dose level of NK cells. A computer will decide by chance which of the dose level you will receive, and this will not be based on the doctor's or patient's decision. Up to 5 dose levels of NK cells will be tested. Each new patient will receive a different dose. If any dose shows to be not tolerable, this dose and the higher doses will not be given anymore.

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