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CAR T-cell Therapy

CAR-T Therapy for B-Cell Lymphoma

Phase 1

Recruiting

Led By Ariela Noy

Research Sponsored by AIDS Malignancy Consortium

Eligibility Criteria Checklist

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

Must have

Participant must have been treated with an anthracycline and rituximab and have R/R disease after at least 2 lines of therapy

Adequate vascular access for leukapheresis procedure and for administration of the cellular product

Must not have

Uncontrolled intercurrent illness

Participants with a second prior or concurrent malignancy that may interfere with the safety or efficacy assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new therapy called axicabtagene clioleucel (a type of CAR-T therapy) to see if it can treat patients with aggressive B-cell non-Hodg

Who is the study for?

This trial is for adults over 18 with HIV and aggressive B-cell non-Hodgkin lymphoma that's relapsed or resistant to treatment. They must have had at least two prior therapies including an anthracycline and rituximab, be PET-positive or have bone marrow involvement, and be in fairly good health (ECOG <=1).

What is being tested?

The trial tests axicabtagene ciloleucel (CAR-T therapy), where patients' T cells are modified to target CD-19 on cancer cells. It aims to see how well these engineered T cells can treat the lymphoma.

What are the potential side effects?

Potential side effects include reactions related to immune response such as fever, fatigue, blood pressure changes, breathing difficulties; neurological issues like confusion or seizures; and a risk of infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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I have received anthracycline and rituximab and my disease is resistant after 2 treatments.

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I have good veins for blood draws and treatments.

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My condition is relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

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I am 18 years old or older.

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My disease shows up on PET scans or is in my bone marrow.

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I am fully active and can carry on all pre-disease activities without restriction.

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My lymphoma is CD19-positive after previous CD19-targeted therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses.

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I do not have another cancer that could affect this treatment's safety or results.

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I am experiencing graft-versus-host disease.

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I have a history of heart conditions.

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I have a significant brain or nerve condition.

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I have previously received CAR T-cell therapy.

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My cancer is only affecting my central nervous system.

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I do not have any untreated infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Feasibility of CAR-T Therapy

Safety of chimeric antigen receptor (CAR) T-cell therapy

Secondary study objectives

CD4 and CD8 counts

Complete response rate

Duration of response (DOR)

+1 more

Other study objectives

Burden of HIV integration in the final CAR T-cell product versus the pheresis product through quantitative polymerase chain reaction

Relationship between immune-mediated response and clinical response and toxicity in human immundeficiency virus (HIV)-associated B-Cell Non-Hodgkin Lymphoma treated with axicabtagene ciloleucel

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: Treatment (conditioning, axicabtagene ciloleucel)Experimental Treatment3 Interventions

Patients receive fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days -5, -4, and -3. Patients then receive axicabtagene ciloleucel IV over 30 minutes on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860