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CAR T-cell Therapy

Kappa CD28 T Cells for Leukemia (CHARKALL Trial)

Phase 1

Recruiting

Led By Carlos 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

If patient has CLL, must have negative Coombs test

B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain

Must not have

Tumor in a location where enlargement could cause airway obstruction

Active infection requiring antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with a type of cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or has not gone away after treatment. The treatment is a gene transfer research study using special immune cells. The study is testing whether combining two different ways of fighting disease, antibodies and T cells, will be more effective than using either method alone.

Who is the study for?

This trial is for patients with certain blood cancers (NHL, MM, CLL) that have relapsed or are treatment-resistant. Participants must be recovered from prior chemotherapy effects, not HIV positive, and willing to use effective birth control. They should have a life expectancy of at least 12 weeks and no recent history of other cancers or active infections.

What is being tested?

The study tests kappa-CD28 T cells designed to fight cancer by combining antibodies with T lymphocytes. The highest safe dose found in earlier phases will be used. These engineered T cells carry an antibody that targets cancer cells and a protein (CD28) expected to enhance their longevity and effectiveness.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's enhancement such as inflammation in various organs, symptoms due to the engineered T cells attacking normal tissues mistakenly (autoimmune-like responses), infusion-related reactions, fatigue, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My Coombs test is negative and I have CLL.

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My cancer is a type of B-cell cancer or multiple myeloma with Kappa-light chain.

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I have B-cell cancer with specific characteristics and have had at least one treatment including Rituximab.

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My T-cells are modified to fight cancer and show more than 15% CAR-Kappa expression.

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I am mostly able to care for myself but may need occasional help.

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My blood clotting tests are within normal limits.

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My kidney function is good.

Exclusion Criteria

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

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

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I am currently taking antibiotics for an infection.

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I have heart problems that cause symptoms.

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 Toxicities (DLT)

Secondary study objectives

To measure the anti-tumor effects of CAR-K+ T lymphocytes.

Other study objectives

Survival and Function of CAR-K+ T cells

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Kappa CD28 T cells for myelomaExperimental Treatment1 Intervention

T cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes.

Group II: Kappa CD28 T cells for B-cell lymphomaExperimental Treatment1 Intervention

Group III: Kappa CD28 T cells for B-CLLExperimental Treatment1 Intervention

0 / 10Eligibility criteria met