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CAR T-cell Therapy

Cell Therapy for Hodgkin's Lymphoma

Phase 1 & 2

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

The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.

Age ≥ 18 years at the time of consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new therapy for Hodgkin's Lymphoma to reduce mortality and alleviate morbidity. It will enrol 25 patients and follow them for 15 years to determine its effectiveness.

Who is the study for?

This trial is for adults over 18 with Classical Hodgkin Lymphoma, who have a Karnofsky score above 60%, indicating they can care for themselves. They must consent to the study and allow their health information to be used. Patients already receiving standard treatments like chemotherapy or radiation may still qualify.

What is being tested?

The trial tests ATLCAR.CD30.CCR4 cells in patients with Hodgkin's Lymphoma. It's an early-phase study determining safe dosage levels and how well these cells work as treatment. Participants will receive cell infusions after a preparatory 'lymphodepletion' process, followed by long-term monitoring.

What are the potential side effects?

While specific side effects are not listed here, CAR-T therapies like ATLCAR.CD30.CCR4 often cause flu-like symptoms, low blood cell counts, risk of infection, neurological issues, and an immune reaction called cytokine release syndrome.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Classical Hodgkin Lymphoma.

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I am 18 years old or older.

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I am mostly able to care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months 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

Phase 1b Toxicity Cytokine Release Syndrome (CRS)

Phase 1b Toxicity Immune effector cell-associated neurotoxicity syndrome (ICANS)

+1 more

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Phase Ib Dose Limiting Toxicity

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: ATLCAR.CD30Experimental Treatment2 Interventions

Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

0 / 3Eligibility criteria met