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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia and Lymphoma (SAGAN Trial)

Phase 1

Recruiting

Led By Carlos A Ramos, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

PROCUREMENT: CD19-positive tumor.

TREATMENT: CD19-positive tumor.

Must not have

PROCUREMENT: Active infection requiring antibiotics.

TREATMENT: Tumor in a location where enlargement could cause airway obstruction.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining two existing methods: T cells and antibodies. Researchers hope that the combination will be stronger than either method alone in fighting the cancer.

Who is the study for?

This trial is for people up to 75 years old with certain types of blood cancers like B-cell lymphoma, ALL, or CLL that have come back or didn't respond to treatment. They should be fit enough for the study and not have infections needing antibiotics, HIV/HTLV, or a history of severe reactions to mouse proteins.

What is being tested?

The trial tests two modified T-cell therapies against aggressive blood cancers. One therapy includes CD19.CAR/28 T cells; the other adds CD137 to enhance effectiveness. The goal is to find the safest high dose, understand side effects, and see if these therapies can help patients.

What are the potential side effects?

Potential side effects may include immune system reactions due to engineered T-cells targeting cancer cells but could also affect normal cells inadvertently. Specifics will be monitored closely given this is an investigational approach.

Eligibility Criteria

Inclusion Criteria

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

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My tumor is CD19 positive.

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My tumor is CD19 positive.

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My kidneys are functioning well.

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My oxygen level is above 90% without needing extra oxygen.

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I am mostly independent and can care for myself.

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My treatment involves T cells from my blood or an identical twin that target CD19.

Exclusion Criteria

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

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I am currently on antibiotics for an active infection.

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My tumor is located where it could block my airway if it grows.

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I do not have an active HIV or HTLV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

Number of patients with dose limiting toxicity (DLT)

Secondary study objectives

Frequency of the two distinct T cell products post infusion

Function of CD19.CAR-ATLs

Number of patients with tumor response

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Expansion: CD19 CAR T Cells for B-cell NHL/CLLExperimental Treatment1 Intervention

Each patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.

Group II: Dose Expansion: CD19 CAR T Cells for B-cell ALLExperimental Treatment1 Intervention

Each patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.

Group III: Dose Escalation: CD19 CAR T Cells for B-cell NHL/CLLExperimental Treatment1 Intervention

Each patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.

Group IV: Dose Escalation: CD19 CAR T Cells for B-cell ALLExperimental Treatment1 Intervention

Each patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.

0 / 9Eligibility criteria met