← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

ATECRAB Trial 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.Check my eligibility

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.See study design

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.

ATECRAB Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

Select...

My tumor is CD19 positive.

Select...

Both I and my donor (if applicable) have been exposed to the Epstein-Barr virus.

ATECRAB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

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

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

Primary outcome measures

Number of patients with dose limiting toxicity

Secondary outcome measures

Number of patients with tumor response

Survival and function of CD19CAR PBTLs and EBV-CTLs

ATECRAB 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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,177 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,814 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,372 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

Frequently Asked Questions

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

Is this research actively seeking participants?

"This particular trial has completed its participant recruitment process and is no longer accepting volunteers. Originally posted on July 1st 2009, the study was edited for a final time on February 6th 2022. Fortunately, there are 2900 other trials actively recruiting patients right now."

Answered by AI

Has the Federal Drug Administration sanctioned autologous or syngeneic PBTLs and EBV-CTLs?

"Safety estimates for autologous or syngeneic PBTLs and EBV-CTLs were assigned a score of 1 due to the preliminary nature of this Phase 1 trial, which lacks substantial data on both effectiveness and safety."

Answered by AI

Recent research and studies

BloodJournal

Xu, Yang, Ming Zhang, Carlos A. Ramos, April Durett, Enli Liu, Olga Dakhova, Hao Liu, et al.. 2014. “Closely Related T-memory Stem Cells Correlate with in Vivo Expansion of CAR.CD19-T Cells and Are Preserved by IL-7 and IL-15”. Blood. American Society of Hematology. doi:10.1182/blood-2014-01-552174.

clinicaltrials.govStudy

T-cells or EBV Specific CTLs, Advanced B-Cell NHL and CLL

Carlos Ramos 2009. "T-cells or EBV Specific CTLs, Advanced B-Cell NHL and CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00709033.

All > Ebv