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CAR T-cell Therapy

CD70-Targeted CAR T-cell Therapy for Cancer

Phase 1 & 2

Recruiting

Led By James C Yang, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age greater than or equal to 18 years and less than or equal to 72 years

Clinical performance status of ECOG 0 or 1

Must not have

Concurrent systemic steroid therapy

History of hematopoietic autoimmune disease or any autoimmune disease requiring immunosuppressive measures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer therapy in which a person's white blood cells are modified with anti-CD70 before being given back to the person. The aim is to see if this can safely shrink tumors.

Who is the study for?

Adults aged 18-72 with CD70-expressing cancers like kidney, breast, or ovarian cancer who've tried at least one standard treatment without success. They must have a certain level of blood cells and organ function, not be pregnant or breastfeeding, HIV negative, and willing to use birth control.

What is being tested?

The trial tests gene transfer therapy using modified white blood cells targeting CD70 on cancer cells. It includes chemotherapy drugs (cyclophosphamide and fludarabine) and aldesleukin before infusing the engineered cells. Participants will be monitored regularly for tumor response and safety.

What are the potential side effects?

Possible side effects include reactions to cell infusion, effects from chemotherapy like nausea or hair loss, increased infection risk due to immune system changes, fatigue, bleeding complications from low platelet counts, liver enzyme elevation indicating potential liver damage.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 72 years old.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer cannot be removed by surgery and tests show it has a high level of CD70.

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My cancer is visible on scans, can't be surgically removed, and tests high for CD70.

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I have finished all my previous cancer treatments.

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My white blood cell count is healthy without needing medication.

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I have tried at least one standard cancer treatment and it did not work or my cancer came back.

Exclusion Criteria

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

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I am currently on systemic steroid therapy.

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I have an autoimmune disease that needs treatment to suppress my immune system.

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I do not have any active infections, bleeding disorders, or major illnesses that are not under control.

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I have had heart surgery or symptoms of reduced blood flow to my heart.

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I have a primary immunodeficiency disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency and severity of treatment-related adverse events

Response rate

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: 2/Phase IIExperimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MTD of anti-hCD70 CAR transduced PBL + high-dose aldesleukin

Group II: 1/Phase IExperimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + escalating doses of anti-hCD70 CAR transduced PBL + high-dose aldesleukin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860