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CAR T-cell Therapy

CAR T-cell Therapy for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By LaQuisa Hill, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CLL-1 positive tumor with at least 30% CLL-1 blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory
Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL) AND suitable for consideration of allogeneic Hematopoietic Stem Cell Transplant with confirmation of an identified eligible donor by a FACT accredited transplant center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post t cell infusion
Awards & highlights

Study Summary

This trial is testing whether combining two ways of fighting cancer, T cells and antibodies, will work better than using them separately to fight cancer.

Who is the study for?
This trial is for adults up to 75 years old with Acute Myeloid Leukemia (AML) that's resistant or returned after treatment. They must have a certain level of CLL-1 protein on their cancer cells, good kidney and liver function, no active infections, HIV or HTLV, not be taking high-dose steroids for GVHD, and not have another active cancer.Check my eligibility
What is being tested?
The study tests CAR-T cells targeting the CLL-1 antigen in AML patients. These modified T-cells are equipped with an antibody against CLL-1 and a CD28 stimulator to enhance their growth and persistence in the body. This investigational therapy aims to improve the immune system's ability to fight leukemia.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune activation such as fever, fatigue, headache; risk of infection; possible damage to non-cancerous cells that also carry CLL-1 antigen; and other complications associated with cell therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is CLL-1 positive with at least 30% CLL-1 blasts.
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I have AML (not APL) that hasn't responded to treatment and am eligible for a stem cell transplant.
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I am 75 years old or younger.
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I need a procedure to collect blood cells for my treatment.
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My hemoglobin level is at least 7.0 g/dL, transfusions are okay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post t cell 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 limiting toxicity (DLT) rate
Secondary outcome measures
Overall Response Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: CLL-1.CARExperimental Treatment1 Intervention
Group A

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,230 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,799 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,879 Total Patients Enrolled

Media Library

CLL-1.CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04219163 — Phase 1
Acute Myeloid Leukemia Research Study Groups: CLL-1.CAR
Acute Myeloid Leukemia Clinical Trial 2023: CLL-1.CAR T cells Highlights & Side Effects. Trial Name: NCT04219163 — Phase 1
CLL-1.CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04219163 — Phase 1

Frequently Asked Questions

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

Is the enrollment phase of this trial still open?

"Per the data hosted on clinicaltrials.gov, this investigational trial is still open for recruitment; it was first posted on July 9th 2020 and most recently updated November 21st 2022."

Answered by AI

Has the FDA sanctioned CLL-1.CAR T cells for medicinal use?

"Our assessment of CLL-1.CAR T cell safety is a 1 on the 1 to 3 scale due to limited data regarding their efficacy and level of security in this Phase 1 trial."

Answered by AI

How many individuals are partaking in the research project?

"Affirmative. Clinicaltrials.gov evidences that this research endeavor, which was uploaded on July 9th 2020, is actively enrolling participants. Only 18 individuals are required--all of whom have to be recruited from a single medical centre."

Answered by AI
~1 spots leftby Jul 2024