ATLCAR.CD30.CCR4 cells for Mycoses

Phase-Based Estimates
1
Effectiveness
1
Safety
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, NC
+18 More
ATLCAR.CD30.CCR4 cells - Biological
Eligibility
18+
All Sexes
Eligible conditions
Mycoses

Study Summary

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

See full description

Eligible Conditions

  • Mycoses
  • Lymphoma, T-Cell, Peripheral
  • Lymphatism
  • Cancer
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoproliferative Disorders
  • Immune System Diseases
  • Lymphoma
  • Lymphoma, T-Cell
  • Immunoproliferative Disorders
  • Disease
  • Granulomatous Slack Skin
  • Lymphomatoid Papulosis
  • Lymphatic Diseases
  • Neoplasms
  • Gray Zone Lymphoma
  • Cutaneous Anaplastic Large Cell Lymphoma
  • Cutaneous Lymphomas
  • Lymphoma, T-Cell, Cutaneous
  • Cutaneous T Cell Lymphomas (CTCL)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether ATLCAR.CD30.CCR4 cells will improve 1 primary outcome and 5 secondary outcomes in patients with Mycoses. Measurement will happen over the course of 6 weeks.

15 years
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.
Persistence of ATLCAR.CD30.CCR4 vs. ATLCAR.CD30 in peripheral blood in subjects who received both ATLCAR.CD30.CCR4 and ATLCAR.CD30 cellular products
6 weeks
Number of participants with adverse events (AE) as a measure of safety and tolerability ATLCAR.CD30.CCR4 and ATLCAR.CD30 cells
7 weeks
Objective response rate by 7 weeks and best overall response rate in subjects with CD30+ relapsed/refractory HL and CTCL after infusion of ATLCAR.CD30.CCR4 with and without ATLCAR.CD30

Trial Safety

Trial Design

2 Treatment Groups

Control
ATLCAR.CD30.CCR4 & ATLCAR.CD30

This trial requires 59 total participants across 2 different treatment groups

This trial involves 2 different treatments. ATLCAR.CD30.CCR4 Cells is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

ATLCAR.CD30.CCR4 & ATLCAR.CD30A 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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 15 years for reporting.

Closest Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Mycoses or one of the other 18 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Classic Hodgkin lymphoma is a disease in which cancer cells form in the lymph system show original
You will need to sign a consent form to allow us to collect your cells, and you will also need to sign a consent form to participate in the CAR T-cell therapy trial show original
What this essentially means is that there is a form of lymphoma that does not fit into the clearly defined categories of either Hodgkin lymphoma or diffuse large B-cell lymphoma (DLBCL), but instead has features that lie somewhere in between these two types of lymphoma. show original
A rare, non-Hodgkin lymphoma that affects the skin, composed of lymphocytes (a type of white blood cell) that are CD30 positive show original
Mycosis fungoides
The study looked at lymphoma patients who had failed two or more prior treatment regimens. show original
Sezary syndrome
The patient's prior treatment must include brentuximab vedotin. show original
The subject must have either failed an autologous transplant or be ineligible for an autologous transplant to be eligible for this study. show original
Adults who are 18 years old or older. show original

Patient Q&A Section

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

How many people get cancer a year in the United States?

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Around 500,000 cases of cancer are diagnosed in the United States every year. About 1,900 cases of skin cancer and 1,200 of lung cancer are diagnosed each year, making skin cancer the most common type of cancer in American adults and lung cancer the most common type of cancer among American adults with cancer. Breast cancer was the second most common type of cancer reported in 2001, the year the latest data on cancer incidence were available. Lung cancer was the most common type of cancer reported in men but only the third most common for women.

Unverified Answer

What are the signs of cancer?

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The most common signs of cancer are red patches of scaling or bleeding on the body. Other signs and symptoms are weight loss, fever, unexplained itching, and loss of appetite.\n

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What causes cancer?

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The causes of cancer are diverse and complicated. A number of risk factors have been identified, such as smoking, alcohol, obesity and an inadequate diet. The mechanism whereby tumors develop is still uncertain, but it is thought that cancer arises from mutated cells. There is probably no single cause of cancer.\n

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What are common treatments for cancer?

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Although common treatment is dependent on the site of origin and type of cancer, most treatments aim to reduce symptoms of cancer-induced pain and to increase general health, while minimizing complications from or prolonging life. Some common treatment may be palliative in nature.

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What is cancer?

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Cancers are a group of malignant diseases of cell division that has a tendency to invade neighboring tissues and spread. In some cases, these malignant tumors result in the death of an individual by internal or external spread. In others, malignant tumors form localized masses that can grow to invade nearby tissues and may metastasize to distant sites. In most cases, the cause is not known. In about 1.5 million cases per year, cancer causes death in the USA and in Europe.

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Can cancer be cured?

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Because we do not have a cure for cancer, the question 'Can cancer be cured?', and the answer 'no', are misleading questions. If we had a cure, they would not be formulated. The cure-model is now a widely held misconception, that cancer patients will be cured. But the cure paradigm is flawed. Some cancer treatments may be curative, and there is no reason to believe that no cure ever can be found for any type of cancer. On the contrary, a cure for cancer would be a miracle cure. The cure-model is so flawed that one cannot discuss or discuss cancer cure. The cure model encourages clinicians and cancer patients to search for a cure. This raises the question 'what is a cure?'.

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What are the latest developments in atlcar.cd30.ccr4 cells for therapeutic use?

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This is probably the first data showing significant growth inhibition of CCR4-positive cancer cells in the presence of anti-CCR4 antibody. Data from a recent study support further investigations and validation of these cells in human cancer patients.

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Who should consider clinical trials for cancer?

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The decision of who should enroll is a tricky issue and depends upon a multitude of factors. To facilitate and improve the inclusion of eligible patients to clinical trials, we recommend the following steps.

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Does cancer run in families?

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The inheritance of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) has been reported only in a minority of cases. This raises the question of whether family history would be worthwhile to consider, even in families without strong family history of breast cancer. This research confirms the notion that breast and ovarian cancer are substantially hereditary, but supports its inclusion if an explanation remains to be found for familial breast or ovarian cancer.

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What is atlcar.cd30.ccr4 cells?

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Cells from the metastatic site are known to lose their epithelial characteristics and the cells on the periphery become indistinguishable with the neighboring healthy tissue. The number the number of mitochondria decreases (thereby affecting respiration)and the cells are more prone to cell growth, division and development of a multinucleated phenotype(frequently seen as cancer cell). This may be a reason for the development of more aggressive cell phenotype when cancer comes in contact with the periphery tissue.

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Have there been other clinical trials involving atlcar.cd30.ccr4 cells?

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A. CD30 cells are highly effective in inducing apoptosis and cell death by complement-mediated apoptosis in human malignant lymphomas. Their cytotoxic activities seem to be dose dependent as the higher the dose the greater the cytotoxic effect. Considering the fact that several CD30-specific chimeric antibodies, e.g. G1, are currently undergoing clinical trials, the possible clinical applications of CD30 cells may be evaluated in CD30-positive cancers.

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