CD4CAR for Leukemia

Phase-Based Estimates
1
Effectiveness
1
Safety
Stony Brook University, Stony Brook, NY
Leukemia+4 More
CD4CAR - Biological
Eligibility
18+
All Sexes
Eligible conditions
Leukemia

Study Summary

This study is evaluating whether a type of engineered white blood cell may help treat certain types of leukemia and lymphoma.

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Eligible Conditions

  • Leukemia
  • Leukemia, T-Cell
  • Lymphoma
  • T Cell Leukemia
  • T-cell Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CD4CAR will improve 1 primary outcome and 7 secondary outcomes in patients with Leukemia. Measurement will happen over the course of 18-24 months.

18-24 months
Clinical Response
Duration of in vivo survival of the CD4CAR.
Number of participants with immune reactions against CD4CAR
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Rate of manufacturing failure
Serum cytokines levels
determine CD4CAR cell subsets during proliferation
trafficking of CD4CAR at tumor sites and at sites with significant toxicity

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. CD4CAR 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.

Treatment
Biological
Redirected autologous T cells transduced with the anti-CD4 lentiviral vector (referred to as "CD4CAR" cells)
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18-24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18-24 months for reporting.

Closest Location

Stony Brook University - Stony Brook, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia or one of the other 4 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:
There are five types of T-cell leukemia, which are peripheral T-cell leukemia, NOS, T-cell prolymphocytic leukemia, adult T-cell leukemia, T-cell large granular lymphocytic leukemia, and T cell acute lymphoblastic leukemia (T-ALL). show original
In order to vote in the United States, you must be 18 years old or older on election day. show original
Creatinine clearance of > 60 ml/min
The liver enzymes are lower than 3 times the upper limit of normal. show original
A level of bilirubin that is less than 2.0 mg/dL is considered normal. show original
Serum albumin of ≥ 3gms/dl
A pulmonary function test (PFT) that measures the diffusing capacity of lung for carbon monoxide (DLCO) must show a value of at least 60%. show original
Patients must sign and date informed consent forms that state their willingness to comply with all study procedures and availability for the duration of the study. show original
/leukemia There are four types of peripheral T-cell lymphoma: 1) Peripheral T-cell lymphoma, not otherwise specified (NOS); 2) Sezary syndrome/cutaneous T-cell lymphoma; 3) Angioimmunoblastic T-cell lymphoma; and 4) Adult T-cell lymphoma/leukemia. show original
Subjects with documented CD4+ hematologic malignancies. Male and female subjects with CD4+ T-cell malignancies with either relapsed or refractory disease (including those patients who have undergone a prior transplant and patients with an inadequate response after 4-6 cycles of standard chemotherapy)

Patient Q&A Section

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

What are common treatments for leukemia?

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Most leukemia can be treated with a combination of chemotherapy, radiation, and leukopheresis. Certain strains of leukemia may not respond to conventional therapy, so there are more limited options. Certain strains of leukemia may not even have effective treatments. The best treatment strategy for a particular patient needs to be individualized.

Unverified Answer

What causes leukemia?

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Some things do increase the risk of developing leukemia, but there is not a single explanation as to why leukemia exists. The most common forms of leukemia are acute and chronic myelogenous leukemias and acute lymphocytic leukemias. Some people are predisposed to developing leukemia, and these individuals are often given a specific diagnosis (e.g. ataxia telangiectasia) to help them prevent leukemia. Other cancers (e.g. solid tumors) can arise from transformed leukemic cells, but are not the same disease. The exact cause of leukemia is unknown.

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What are the signs of leukemia?

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Acute leukemia affects approximately 25 percent of patients with malignant lymphoproliferative disorder. The following findings are signs of leukemia: a very low or rising white blood cell count; a rapid rate of white blood cell production; symptoms related to anemia; and easy bruising. Bone pain and fever can result from neutrophilia or leukemic cell infiltration in nearby bone. Fertility problems or shortness of breath may result from leukemia affecting the liver, lungs or lungs. Some signs and symptoms of leukemia are non-specific. A change in weight, feeling tired, and fatigue may be first signs of leukemia, and patients with these symptoms should speak with their health care professionals.

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What is leukemia?

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Cancer is a disease involving abnormal growth of neoplastic (malignant) cells. The term "leukemia" refers to a group of unrelated diseases that involve the malignant proliferation of one or more blood and/or bone marrow cells. The term "leukemia" describes diseases having the following three features: neoplastic multiplication within the marrow, the blood, or both, failure of normal cell differentiation, and the appearance of a leukemic mass (mass of malignant cells). The classification of these diseases has evolved over the years and remains a work in progress.

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Can leukemia be cured?

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In this population of [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia), there was a clear trend towards long-term, remissions of leukemia in the group treated with leucovorin and procarbazine without autoresponse. We cannot conclude that this treatment prevents a relapse of the disease in these patients. Findings from a recent study should be confirmed by a multicenter study of a larger population to confirm the findings.

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

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About 36,000 people are diagnosed with leukemia in the United States each year, making up 6% of all diagnoses. This represents 5% of all solid tumors in the country in 2017.

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How quickly does leukemia spread?

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Spread is the final aspect of leukemia, and not all leukemia cells are going to reach the blood, only leukemia cells that are able to be found in the peripheral blood. This is important because peripheral blood (without the marrow) is where cancer cells can spread to your blood, so the more leukemia cells you have in your blood then the quicker you are going to start noticing more disease (whether it be a chronic or an acute leukemia)

Unverified Answer

What does cd4car usually treat?

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The overall response rate was 55%. The combination of HAART with chemotherapy had a higher response rate and longer median time to treatment. The higher response after HAART may be owing to the decreased levels of virological replication in chronically immunosuppressed patients.

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Is cd4car safe for people?

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Patients with CD4 counts below 500/microl were at risk, however, if CD4 stays below 500/microl, death rates remain low even in patients already on HAART. Whether this risk of death is due to the use of CD4Car remains undefined. The study may have been underpowered to detect a possible increase in risk but it does not support the contention that the drug is potentially dangerous. There was insufficient data to show long-term safety of CD4Car compared to HAART.

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How serious can leukemia be?

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Patients with AML have the lowest quality of life among the most common cancers. AML survivors are at greater risk of death due to causes that do not appear to arise from cancer, even after adjusting for cancer treatments. The impact can be particularly devastating for young adults who do not expect to live past ten years. Results from a recent paper have implications for the prognosis of older adults seeking AML treatment as well as the treatment of other patients with cancer.

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Does cd4car improve quality of life for those with leukemia?

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This multicenter study adds substantially to the current literature by demonstrating that a mobile HIV care clinic does not compromise overall quality of life or health-related beliefs of participants, thus supporting its continued use.

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Who should consider clinical trials for leukemia?

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Data from a recent study indicate that patients should be offered clinical trials when the condition is curable. Clinicians who have a clear desire and purpose in clinical trials, are able to explain to patients the relevant clinical trials and obtain their consent will feel rewarded by their participation. It appears that patients must be informed of relevant side effects before deciding to participate in clinical trials as we see in the patient group receiving the lowest score of this study.

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Get access to this novel treatment for Leukemia by sharing your contact details with the study coordinator.