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CAR T-cell Therapy

CD30 CAR T-Cell Therapy for Lymphoma

Phase 1 & 2

Recruiting

Led By Anne Beaven, 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

Karnofsky or Lansky score of >60% (Karnofsky for pediatric subjects ≥16 years old and Lansky for <16 years old).

Ages 3 to 17 years of age for pediatric subjects (weight must be ≥10kg), and for adults ages ≥18 years of age

Must not have

Tumor in a location where enlargement could cause airway obstruction.

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 combining two different ways of fighting disease, antibodies and T cells, in order to create a more effective treatment against cancer.

Who is the study for?

This trial is for adults and children with certain types of lymphoma (HL and NHL) that have returned or resisted treatment. Participants must not be pregnant, should use birth control if applicable, cannot have severe infections like HIV/HCV/HTLV, no recent cancer vaccines or CD30 antibody therapy, and must have good organ function. They also shouldn't be on high-dose steroids or medications that interfere with the chemotherapy drug bendamustine.

What is being tested?

The study tests ATLCAR.CD30 cells in patients after chemotherapy to find a safe dose and see how well it prevents cancer progression over two years. These are T cells modified with a new gene to target CD30+ lymphoma cells more effectively by using a combination of antibodies and T cell mechanisms.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, inflammation in various organs due to targeted cell destruction; risk of infection from weakened immune response post-chemotherapy; possible infusion-related reactions when receiving the modified T cells.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do active work or play.

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I am either between 3 to 17 years old and weigh at least 10kg, or I am 18 years or older.

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My blood, liver, and kidney functions meet the required levels.

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My tumor is not located where it could block my airway if it grows.

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I am not taking strong CYP1A2 inhibitors like fluvoxamine or ciprofloxacin.

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I do not have any ongoing serious infections.

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I have had hepatitis B but it hasn't reactivated since my initial test.

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My liver, kidneys, and lungs are functioning well according to recent tests.

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My blood counts, liver and kidney functions are within normal ranges, and I can breathe well on my own.

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I haven't had any cancer treatment not required by the study before my second infusion.

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My liver and kidney functions are within normal limits, and I can breathe well on my own.

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I am not pregnant, or I am post-menopausal or have not started menstruating.

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I am mostly able to care for myself and carry out daily activities.

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My kidney function, measured by serum creatinine, is within the required range for my age and gender.

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I can care for myself but may not be able to do active work or play.

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

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I do not have an active, poorly controlled HIV, HTLV, or HCV infection.

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I am not taking medications like fluvoxamine or ciprofloxacin that strongly affect drug metabolism.

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I have not had anti-CD30 antibody therapy in the last 4 weeks.

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

2 year progression free survival (PFS) after administration of ATLCAR.CD30 in combined adult/pediatric patients with CD30+ refractory/relapsed HL and NHL.

Number of participants with adverse events as a measure of safety and tolerability of ATLCAR.CD30 cells to establish a safe dose after lymphodepletion after lymphodepletion with bendamustine and fludarabine in pediatric patients

Number of participants with adverse events as a measure of safety and tolerability of ATLCAR.CD30 cells to establish a safe dose after lymphodepletion with bendamustine in adult patients

Secondary study objectives

2 year overall survival (OS) after administration of ATLCAR.CD30 transduced ATl following lymphodepletion with bendamustine in adult patients with CD30+ refractory/relapsed HL and NHL

2 year overall survival (OS) after administration of CAR.CD30 transduced ATL following lymphodepletion with bendamustine and fludarabine in adult and pediatric patients with CD30+ relapsed/refractory HL and NHL.

2 year progression free survival after administration of ATLCAR.CD30 following lymphodepletion with bendamustine and fludarabine in adult and pediatric patients with CD30+ refractory/relapsed HL and NHL.

+13 more

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.CD30 cellsExperimental Treatment1 Intervention

Phase Ib: In adults, and separately, in children, two doses will be investigated 1x10\^8 cells/m2 and 2x10\^8 cells/m\^2. The study team will run two independent dose-escalation sequences, one for adults and another one for children. The study team plans to use the 3+3 design and start with a low dose of 1x10\^8 cells/m2. If there are no DLT in first 3 patients, the study team will go up to the dose of 2 x 10\^8 cells/m2. If there is toxicity in 1/3 patients in the initial cohort, the study team would expand to enroll up to 6 patients. If there are dose limiting toxicities (DLT) at the dose of 2 x 10\^8 cells/m\^2, the study team will initially decrease the dose to an intermediate dose of 1.5 x 10\^8 cells/m\^. Phase II: The study team planning to enroll 31 patients to contribute data. Sequential boundary will be used to monitor DLT rate.

0 / 20Eligibility criteria met