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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
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 belowSelect...
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:Select...
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.
Select...
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
Treatment Details
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
Cyclophosphamide
2010
Completed Phase 4
~2320
Fludarabine phosphate
2007
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,651 Total Patients Enrolled
David Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
2,947 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had targeted radiation before chemo, but still have untreated cancer areas.I can do all my daily activities without help.My cancer shows high CD70 levels in tests.It has been over 3 months since my last cell therapy for cancer.I stopped my last strong cancer treatment at least 2 weeks ago and any targeted therapy 3 days before starting the new treatment.I do not have any serious health conditions that could make the treatment unsafe for me.My kidney, liver, heart, lungs, blood, and clotting functions are all within normal ranges.I am between 18 and 80 years old.I am not pregnant and can become pregnant.I have active hepatitis B or C, or HIV with a detectable viral load.I weigh at least 40 kg.I have symptoms or uncontrolled issues in my brain or spinal cord.I am currently fighting an infection that needs IV drugs or isn't getting better with treatment.I haven't had an active autoimmune disease, except for mild psoriasis or stable thyroid issues, in the last year.I have been diagnosed with amyloidosis or POEMS syndrome.I have an active neurological disorder.I have severe side effects from past cancer treatment.I haven't had any cancer except for certain skin cancers or cervical cancer in the last 2 years.My condition is either Renal Cell Carcinoma, Mesothelioma, or Osteosarcoma.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy and NK Cell Infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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