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CAR T-cell Therapy

CAR-T Cell Therapy for B-Cell Leukemia (TRICAR-ALL Trial)

Phase 1
Recruiting
Led By Meenajshi Hegde, 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
Projected age ≥ 12 months and ≤ 21 years at the time of TRICAR-ALL T cell infusion (first three patients enrolled on dose level 1 will be 12 years and older)
Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 28 days of the tricar-all t cell infusion.
Awards & highlights

TRICAR-ALL Trial Summary

This trial is testing a new way to fight blood cancer by combining two existing methods. Antibodies and T cells are being joined together to create CAR-T cells, which are then further enhanced with the addition of the 4-1BB protein.

Who is the study for?
This trial is for young people aged 12 months to 21 years with B cell Acute Lymphoblastic Leukemia that's resistant or has returned. They must weigh at least 10 kg, have certain levels of liver and kidney function, a good heart function score, and be expected to live more than 8 weeks. Those who can get pregnant must agree to use effective birth control during the study.Check my eligibility
What is being tested?
The trial tests 'TRICAR-ALL' T-cells combined with lymphodepletion chemotherapy in patients with leukemia. These special T-cells are engineered in the lab to target cancer cells more effectively by using a modified antibody that sticks to three specific proteins on leukemia cells.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever, fatigue, difficulty breathing, changes in blood pressure, and organ inflammation. There may also be risks associated with the chemotherapy used before receiving the CAR-T cells.

TRICAR-ALL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 21 years old and eligible for the TRICAR-ALL T cell infusion.
Select...
My leukemia is not responding to treatment and has markers CD19, CD20, or CD22.
Select...
I weigh at least 10 kg.

TRICAR-ALL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 28 days of the tricar-all t cell infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 28 days of the tricar-all 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 by CTCAE v5.0

TRICAR-ALL Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous TRICAR-ALL T-Cells and lymphodepletion chemotherapyExperimental Treatment1 Intervention
Three dose levels will be evaluated. The TRICAR-ALL T-cells will be administered after lymphodepletion chemotherapy with Cyclophosphamide and fludarabine.

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,779 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,210 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,859 Total Patients Enrolled

Media Library

TriCAR T-cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05010564 — Phase 1
B-Cell Leukemia Research Study Groups: Autologous TRICAR-ALL T-Cells and lymphodepletion chemotherapy
B-Cell Leukemia Clinical Trial 2023: TriCAR T-cells Highlights & Side Effects. Trial Name: NCT05010564 — Phase 1
TriCAR T-cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010564 — Phase 1

Frequently Asked Questions

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

Can you brief me on the hazards associated with Autologous TriCAR T-cells and lymphodepletion chemotherapy?

"Due to the research's Phase 1 status and limited proof of efficacy, our team at Power has assigned Autologous TriCAR T-cells and lymphodepletion chemotherapy a score of 1 for safety."

Answered by AI

Are there still openings for enrolment in this trial?

"As reported by clinicaltrials.gov, the initial posting of this medical trial was on March 1st 2022 and its last update occured November 3rd 2021. Consequently, it is not currently recruiting participants; however, there are 1418 other trials that remain open to applicants."

Answered by AI
~25 spots leftby Jul 2026