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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

Karnofsky score of > 60%

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is testing a new way to fight cancer by combining two different types of cells. Antibodies are proteins that protect the body from disease, and T cells are special blood cells that can kill other cells, including cancer cells. The new treatment, ATLCAR.CD30.CCR4, is a combination of these two types of cells, and it is being tested to see if it is more effective than either one alone.

Who is the study for?

This trial is for adults over 18 with certain types of lymphoma, like Mycosis fungoides or Sezary syndrome, that have not improved after at least two treatments. Participants must have CD30+ disease and adequate organ function. They cannot be on strong CYP1A2 inhibitors, have uncontrolled infections, or be pregnant. Those with HIV, HTLV, HCV or active hepatitis B are excluded.Check my eligibility

What is being tested?

The study tests new cancer treatments using T cells genetically modified to target CD30+ lymphoma cells. One group receives ATLCAR.CD30.CCR4 cells designed to navigate towards tumors; another gets these plus additional ATLCAR.CD30 cells. The goal is to find the safest dose for these therapies.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to the engineered T-cells targeting healthy tissue by mistake (autoimmunity), infusion-related reactions from the cell therapy administration process, and typical chemotherapy-associated risks such as fatigue and increased infection susceptibility.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am able to care for myself but may not be able to do active work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AE) as a measure of safety and tolerability ATLCAR.CD30.CCR4 and ATLCAR.CD30 cells

Secondary outcome measures

Differential infiltration of ATLCAR.CD30.CCR4 vs. ATLCAR.CD30 cells in tumor biopsies in subjects who received both ATLCAR.CD30.CCR4 and ATLCAR.CD30 cellular products

Median overall survival (OS) in subjects with CD30+ relapsed/refractory HL and CTCL after administration of ATLCAR.CD30.CCR4 with and without ATLCAR.CD30

Median progression free survival (PFS) after infusion of ATLCAR.CD30.CCR4 with and without ATLCAR.CD30 in subjects with CD30+ relapsed/refractory HL and CTCL.

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ATLCAR.CD30.CCR4 & ATLCAR.CD30Experimental Treatment4 Interventions

A 3+3 design in adult subjects. Subjects in the first dose level will receive ATLCAR.CD30.CCR4 cells alone, once safety has been established, the initial dose of ATLCAR.CD30.CCR4 will be combined with a fixed dose of ATLCAR.CD30 cells in the next dose level. Every time the dose of ATLCAR.CD30.CCR4 is escalated, subjects in that dose level will receive ATLCAR.CD30.CCR4 alone prior to subsequent dose level enrolling subjects to receive a combination of fixed dose ATLCAR.CD30 and the selected dose level of ATLCAR.CD30.CCR4. The six dose levels will consist of: dose level 1 = 2 × 10^7 ATLCAR.CD30.CCR4 cells/m2; dose level 2 = 1 × 10^8 ATLCAR.CD30 cells/m2 and 2 × 10^7 ATLCAR.CD30.CCR4 cells/m2; dose level 3 = 5 × 10^7/m2 ATLCAR.CD30.CCR4 cells/m2; dose level 4 = 1 × 10^8 ATLCAR.CD30 cells/m2 and 5 × 10^7 ATLCAR.CD30.CCR4 cells/m2; dose level 5 = 1 × 10^8/m2 ATLCAR.CD30.CCR4 cells/m2; dose level 6 = 1 × 108 ATLCAR.CD30 cells/m2 and 1 × 108 ATLCAR.CD30.CCR4 cells/m2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Bendamustine

2015

Completed Phase 3

~2950

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,274 Total Patients Enrolled

25 Trials studying Lymphoma

19,914 Patients Enrolled for Lymphoma

University Cancer Research Fund at Lineberger Comprehensive Cancer CenterUNKNOWN

3 Previous Clinical Trials

69 Total Patients Enrolled

Stand Up To CancerOTHER

51 Previous Clinical Trials

40,235 Total Patients Enrolled

1 Trials studying Lymphoma

41 Patients Enrolled for Lymphoma

Media Library

ATLCAR.CD30 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03602157 — Phase 1

Lymphoma Research Study Groups: ATLCAR.CD30.CCR4 & ATLCAR.CD30

Lymphoma Clinical Trial 2023: ATLCAR.CD30 Highlights & Side Effects. Trial Name: NCT03602157 — Phase 1

ATLCAR.CD30 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03602157 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment for this medical study?

"Affirmative. Clinicaltrials.gov provides evidence that this trial, which was first published on December 12th 2018 and has been recently modified on November 11th 2022 is actively searching for participants. 59 patients are required to be brought in from a single medical centre."

Answered by AI

What medical purpose do ATLCAR.CD30.CCR4 cells typically serve?

"The ATLCAR.CD30.CCR4 cell line is capable of providing therapeutic relief to patients suffering from waldenstrom macroglobulinemia, refractory mantle cell lymphoma, and chronic lymphocytic leukemia (CLL)."

Answered by AI

Are any openings still available for participants in this research trial?

"The clinical trial is still open to applicants and was initially posted on December 12th, 2018. Recent updates were applied on November 11th 2022 as per the listing on clinicaltrials.gov."

Answered by AI

Has the FDA sanctioned ATLCAR.CD30.CCR4 cells for therapeutic use?

"Our research team at Power concluded that ATLCAR.CD30.CCR4 cells are likely safe to use, awarding them a score of 1 due to their Phase 1 trial status which indicates limited support for both safety and efficacy."

Answered by AI

Has there been any prior research related to ATLCAR.CD30.CCR4 cells?

"Presently, 434 clinical trials exploring ATLCAR.CD30.CCR4 cells are in progress with 41 of those studies taking place during Phase 3. Most research sites for this cellular line can be found within the Boston area, though a total 8484 locations around the world have some involvement in these investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL

2018. "Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03602157.

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