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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia and Lymphoma

Phase 1

Recruiting

Research Sponsored by Huda Salman, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Adult T-cell leukemia

- Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment - CAR T cells - to see if it's safe and tolerated by patients with T-cell leukemia or lymphoma.

Who is the study for?

Adults over 18 with certain types of T-cell leukemia or lymphoma that have come back or didn't respond to treatment can join. They must be willing to follow the study plan and have a good level of organ function, including kidney, liver, heart, and lungs. Pregnant women, those with active hepatitis B/C or HIV, low lymphocyte counts, or on high-dose steroids are excluded.Check my eligibility

What is being tested?

The trial is testing CD4CAR T-cells in patients with relapsed/refractory T-cell leukemia/lymphoma. It's an early-phase study (Phase I) looking at how safe it is and if it's feasible to use these engineered cells as treatment. Participants will receive one type of intervention without comparison.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to cell therapy like fever and fatigue; risk of infection; possible damage to organs where CD4+ cells are present; infusion-related reactions; and other unforeseen complications related to gene therapy.

Eligibility Criteria

Inclusion Criteria

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

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I have adult T-cell leukemia.

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I have been diagnosed with BPDCN.

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I have been diagnosed with adult T-cell lymphoma.

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I am 18 years old or older.

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I have been diagnosed with T-cell large granular lymphocytic leukemia.

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I have Sezary syndrome or cutaneous T-cell lymphoma.

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I have been diagnosed with T-cell prolymphocytic leukemia.

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I have been diagnosed with angioimmunoblastic T-cell lymphoma.

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I have T cell acute lymphoblastic leukemia.

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My leukemia has come back or is not fully gone.

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I have been diagnosed with a type of leukemia called Peripheral T-cell leukemia, NOS.

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I can undergo apheresis without any health issues.

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I have been diagnosed with peripheral T-cell lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Therapeutic procedure

Secondary outcome measures

Clinical Response

Determine CD4CAR cell subsets during proliferation

Duration of in vivo survival of the CD4CAR.

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Redirected autologous T cells transduced with the anti-CD4 lentiviral vector (referred to as "CD4CAR" cells)

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Huda Salman, MDLead Sponsor

iCell Gene TherapeuticsIndustry Sponsor

13 Previous Clinical Trials

227 Total Patients Enrolled

Huda SalmanLead Sponsor

2 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

CD4CAR (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03829540 — Phase 1

T-Cell Lymphoma Research Study Groups: Treatment

T-Cell Lymphoma Clinical Trial 2023: CD4CAR Highlights & Side Effects. Trial Name: NCT03829540 — Phase 1

CD4CAR (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03829540 — Phase 1

Frequently Asked Questions

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

Does the research team currently have openings for participation in this experiment?

"As implified by the clinicaltrials.gov entry, this trial is not presently enrolling volunteers. Initially posted on June 18th 2019 and most recently edited September 16th 2022, applicants are unable to join at present; though 2816 other studies are actively searching for participants currently."

Answered by AI

What potential hazards accompany the utilization of CD4CAR therapeutically?

"Our experts at Power rated CD4CAR's safety a 1 as this is an initial phase trial, meaning there are few data points regarding its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD4CAR for CD4+ Leukemia and Lymphoma

Huda Salman 2020. "CD4CAR for CD4+ Leukemia and Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03829540.