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CAR T-cell Therapy

CAR T Cell Therapy for Chronic Myelomonocytic Leukemia

Phase 1

Recruiting

Led By Huda Salman, MD, PhD

Research Sponsored by Huda Salman

Eligibility Criteria Checklist

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

Must have

Diagnosis of CMML that is CD4+ and is recurrent or refractory to first line standard of care treatment

Adequate venous access for apheresis and no other contraindications for leukapheresis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28 through 6 months post-infusion

Awards & highlights

Study Summary

This trial tests a new type of cell therapy to see if it's safe and feasible for people with a certain type of cancer.

Who is the study for?

Adults with Chronic Myelomonocytic Leukemia (CMML) that has come back or didn't respond to first treatments can join. They must have normal liver and kidney function, good heart health, and no serious mental disorders or drug abuse history. Pregnant women, those with active hepatitis B/C, HIV, other cancers needing recent treatment, uncontrolled infections or autoimmune diseases requiring systemic therapy are excluded.Check my eligibility

What is being tested?

The trial is testing a new type of T-cell therapy called CD4CAR for people whose CMML has relapsed or is resistant to initial treatments. It's an early-phase study focusing on the safety and practicality of using these engineered T-cells in patients.See study design

What are the potential side effects?

Potential side effects aren't detailed here but may include immune system reactions due to the modified T-cells attacking healthy cells as well as typical risks associated with cell therapies such as fever, fatigue, infection risk increase.

Eligibility Criteria

Inclusion Criteria

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

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My CMML is resistant to initial treatments and tests positive for CD4.

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I can undergo apheresis with no issues.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28 through 6 months post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28 through 6 months post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 through 6 months post-infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the dose limiting toxicity (DLT) of the CD4CAR in CMML

The efficacy of treatment with CD4CAR and description of CMML response to CD4CAR

Secondary outcome measures

efficiacy of the CD4CAR to target T regulatory cells and myeloid derived suppressor cells

in vivo persistence of a single dose of the CD4CAR in patients with CMML

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

iCell Gene TherapeuticsIndustry Sponsor

13 Previous Clinical Trials

217 Total Patients Enrolled

Huda SalmanLead Sponsor

2 Previous Clinical Trials

50 Total Patients Enrolled

The Leukemia and Lymphoma SocietyOTHER

82 Previous Clinical Trials

17,101 Total Patients Enrolled

Frequently Asked Questions

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

What safety measures have been implemented to ensure the efficacy of this treatment for individuals?

"Assigned a score of 1, this experimental therapy has only undergone limited testing for both safety and efficacy."

Answered by AI

Are people still able to enrol in this research project?

"The clinicaltrials.gov page confirms that this trial is no longer accepting candidates, which it has done so since October 2nd 2023. Although the recruitment period for this investigation has come to an end, 1437 other trials are actively hunting for patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.

Huda Salman 2024. "Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06071624.

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