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CAR T-cell Therapy

CAR T-Cell Therapy for Lymphoma

Phase 1

Recruiting

Led By Natalie Grover, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma

Diagnosis of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma OR histologically confirmed B-cell NHL

Must not have

A diagnosis of lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia or multiple myeloma

Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will use T cells and antibodies to create a more effective treatment for cancer.

Who is the study for?

This trial is for adults over 18 with certain types of B-cell lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma that have relapsed or are not responding to treatment. Participants must have adequate organ function, no uncontrolled infections, and women of childbearing potential must use birth control. Those with active hepatitis, HIV, certain other cancers, or intolerance to specific drugs cannot join.

What is being tested?

The study tests a new therapy using T cells engineered to carry a chimeric antigen receptor (CAR) targeting the kappa light chain on cancer cells. It aims to determine the safety and effectiveness of these modified T cells (ATLCAR.κ.28) in treating lymphoma by starting with various doses before settling on one for further evaluation.

What are the potential side effects?

Potential side effects may include immune reactions due to CAR T cell infusion such as fever, fatigue, headache; risk of infection; possible damage to organs where kappa light chains are present; allergic reactions from components used in cell modification process.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is between DLBCL and Hodgkin.

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I have been diagnosed with a type of blood cancer that has come back or didn’t respond to treatment.

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My lymphoma or CLL/SLL shows kappa-positive expression.

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My organs are functioning well.

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My T-cells have been modified and meet specific quality standards.

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I haven't had chemotherapy or immunotherapy in the last 3 weeks.

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I am not on any medication that this study does not allow.

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I do not have any ongoing serious infections.

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My lymphoma or CLL/SLL is kappa-positive.

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My last treatment was over 3 weeks ago before starting lymphodepletion.

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My cancer is only in my bone marrow.

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My cancer returned after a stem cell transplant.

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My lymphoma is high grade with specific genetic changes.

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I have a specific type of large B-cell lymphoma.

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I have had at least 2 treatments for my slow-growing lymphoma.

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I am 18 years old or older.

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I have had CD19 CAR therapy for my relapsed or hard-to-treat disease.

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I am using two birth control methods or am not having sex to join this study.

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My aggressive lymphoma has not responded to at least 2 previous treatments.

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I have had at least 2 treatments for my chronic leukemia or lymphoma.

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

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I have been diagnosed with primary mediastinal large B-cell lymphoma.

Exclusion Criteria

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

Select...

I have been diagnosed with lymphoma, Waldenstrom's macroglobulinemia, or multiple myeloma.

Select...

I am currently taking 10 mg or more of prednisone daily or its equivalent.

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 participants with adverse events as a measure of safety and tolerability of CAR.κ.28 ATL cells

Secondary study objectives

Heart rate

Overall survival (OS) after administration of CAR.κ.28 cells

Progression free survival (PFS) after infusion of CAR.κ.28 cells

Other study objectives

Duration of response after administration of CAR.κ.28 cells

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: CAR.k.28/CAR.k.4-1BBExperimental Treatment4 Interventions

Up to 12 patients will receive a single infusion of CAR.k.28. The starting dose will be 2.5x10\^5 cells/kg of each product. Up to 3 dose levels of CAR.k.28 cells will be tested with at least 3 patients enrolled at each dose cohort before dose escalation is considered based on the incidence of dose limiting toxicity (DLT). An expansion cohort will enroll up to 8 patients at the recommended phase 2 dose. Prior to receiving the infusions, patients will undergo lymphodepletion with fludarabine and bendamustine. Patients with a known history of intolerance to bendamustine may be considered for lymphodepletion with fludarabine and cyclophosphamide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310