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CAR T-cell Therapy

T-cell Therapy for Lymphoma (ATECRAB Trial)

Phase 1
Waitlist Available
Led By Carlos Ramos, 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
Recurrent low or intermediate grade B-cell lymphoma or B-CLL, or newly diagnosed patients unable to receive or complete standard therapy
No treatment with rituximab within the previous 8 weeks
Must not have
Active infection with HIV, HBV, HCV or CMV
Tumor in a location where enlargement could cause airway obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to fight cancer by combining two existing methods. Antibodies stick to cancer cells, and T cells are special infection-fighting blood cells that can kill other cells. The hope is that by combining these two methods, the cancer cells will be killed more effectively.

Who is the study for?
This trial is for people with certain types of blood cancers like non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia that have returned or persisted despite treatment. Participants must be over the worst side effects of past treatments, not on other experimental drugs, and without severe liver, heart, or kidney issues. They should also not be pregnant, free from serious infections like HIV/HBV/HCV/CMV, and willing to use effective birth control.
What is being tested?
The study tests T cells modified with an anti-CD19 antibody (chimeric receptor-T cells) and a protein CD28 to make them more active against cancer. It also uses T cells trained to fight Epstein-Barr Virus (EBV). The goal is to find the highest safe dose of these chimeric T cells, understand their longevity in the body and side effects, and see if they help treat lymphoma or CLL.
What are the potential side effects?
Potential side effects may include reactions related to immune response such as fever or fatigue; risk of infection; possible allergic reactions due to murine proteins in the therapy; organ inflammation; breathing difficulties if tumors enlarge near airways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recurring low or intermediate grade B-cell lymphoma or B-CLL, or I can't complete standard therapy.
Select...
I haven't received rituximab in the last 8 weeks.
Select...
I agree to use effective birth control during and for 3 months after the study.
Select...
I have relapsed or refractory intermediate B cell lymphoma and will undergo high dose therapy and a stem cell transplant.
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My tumor is CD19 positive.
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Both I and my donor (if applicable) have been exposed to the Epstein-Barr virus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have an active infection with HIV, hepatitis B, hepatitis C, or CMV.
Select...
My tumor is located where it could block my airway if it grows.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with dose limiting toxicity
Secondary study objectives
Number of patients with tumor response
Survival and function of CD19CAR PBTLs and EBV-CTLs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: autologous or syngeneic PBTLs and EBV-CTLsExperimental Treatment1 Intervention
The subject will be assigned a dose of CD19-CD28 chimeric receptor T cells at study entry.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,025 Previous Clinical Trials
6,029,776 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,852 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
286 Previous Clinical Trials
81,745 Total Patients Enrolled
Carlos Ramos, MDPrincipal InvestigatorBaylor College of Medicine
6 Previous Clinical Trials
202 Total Patients Enrolled

Media Library

Autologous or Syngeneic PBTLs and EBV-CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00709033 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: autologous or syngeneic PBTLs and EBV-CTLs
Chronic Lymphocytic Leukemia Clinical Trial 2023: Autologous or Syngeneic PBTLs and EBV-CTLs Highlights & Side Effects. Trial Name: NCT00709033 — Phase 1
Autologous or Syngeneic PBTLs and EBV-CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00709033 — Phase 1
~0 spots leftby Dec 2025
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