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CAR T-cell Therapy

B7-H3CART for Solid Tumors

Phase 1

Recruiting

Led By Sneha Ramakrishna, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Histologically confirmed malignant solid tumor with evidence of incurable disease and tumor recurrence/progression after all available curative standard therapies

Normal organ and marrow function criteria

Must not have

History of other malignancy within the last 3 years, except non-melanoma skin cancer or carcinoma in situ

History of significant cardiac disease within 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if it is possible to safely give a new treatment called B7-H3CART through an IV to children and young adults with certain types of solid tumors that have not responded to

Who is the study for?

This trial is for children and young adults with solid tumors like sarcoma, neuroblastoma, or osteosarcoma that have come back or didn't respond to previous treatments. The tumors must express a target called B7-H3. Specific eligibility details are not provided but would typically include health status and prior therapies.

What is being tested?

The study is testing the safety of a new therapy where patients receive an IV dose of genetically engineered T cells (B7-H3CART) designed to attack cancer cells expressing B7-H3. It follows a '3+3' design which means small groups are given increasing doses to find the safest amount.

What are the potential side effects?

Potential side effects aren't listed but may include immune reactions as the body's normal tissues can be affected by CAR T-cell therapies, flu-like symptoms, fatigue, fever, and risk of infection due to altered immune response.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is incurable, has returned or worsened after all treatments.

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My organs and bone marrow are functioning normally.

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I am receiving specific treatments for my type of cancer.

Exclusion Criteria

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

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I haven't had any cancer except for skin cancer or early-stage cancer in the last 3 years.

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I have had serious heart problems in the last year.

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I am currently on systemic corticosteroids or immunosuppressants.

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I have brain metastases that haven't been treated or my CNS tumor is unstable.

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I do not have any uncontrolled infections or ongoing HIV/Hepatitis B/C.

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I have not had a primary immunodeficiency or autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of manufacturing autologous T cells

Safety and identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of a single dose of intravenous B7-H3CART

Secondary study objectives

Clinical response in children and young adults

Safety of B7-H3CART at the MTD/RP2D

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: LymphodepletionExperimental Treatment1 Intervention

Fludarabine 30 mg/m2 per day IV for 4 days: 5, -4, 3, -2 Cyclophosphamide 500 mg/m2 per day IV for 3 days: -5, -4, -3 Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0.

0 / 9Eligibility criteria met