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CAR T-cell Therapy

CAR-T Cell Therapy for Lymphoma and Leukemia

Phase 1

Recruiting

Led By Anusha Kalbasi, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

MCL, FL, CLL, and SLL: primary refractory; relapsed after three or more prior rounds of therapy

DLBCL and PMBCL: primary refractory; relapsed after two prior lines of therapy

Must not have

Adequately treated cervical carcinoma in situ without evidence of disease

Malignancy treated with curative intent and no known active disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of CAR-T cells on patients with B-cell lymphoma or chronic lymphocytic leukemia that has come back or stopped responding to treatment.

Who is the study for?

This trial is for adults with certain types of B-cell lymphoma or chronic lymphocytic leukemia that haven't improved after standard treatments. Participants need to have a specific level of organ function, blood cell counts within set ranges, and at least 30% of their cancer cells must express CD19 or CD20 proteins.

What is being tested?

The trial tests modified immune cells (CD19/CD20 CAR-T Cells) combined with chemotherapy drugs cyclophosphamide and fludarabine phosphate. It aims to find the safest dose and see how effective this treatment is against recurrent or refractory non-Hodgkin's B-cell lymphoma or chronic lymphocytic leukemia.

What are the potential side effects?

Possible side effects include flu-like symptoms, fatigue, fever, chills, breathing difficulties, low blood pressure, nausea, headache; there may also be risks related to the infusion process itself and potential serious complications like neurologic events or severe immune reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer did not respond to initial treatment or has come back after 3+ treatments.

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My lymphoma did not respond to initial treatment or has returned after two treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lymphoma or leukemia does not respond to standard treatments.

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My lymphoma tumor is at least 1.5 cm^3 in size.

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My cancer cells are mostly positive for CD19 or CD20.

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I am willing to undergo a procedure to collect white blood cells.

Exclusion Criteria

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

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My cervical cancer was treated and shows no signs of being present.

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My cancer was treated to be cured and currently shows no active signs.

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My bladder cancer has been treated and is not invasive.

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I am mentally capable of understanding and following the study's requirements.

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I had non-melanoma skin cancer, but it's now treated and shows no signs of disease.

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My lung function test shows I have reduced breathing capacity.

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My prostate cancer has a low Gleason score and my PSA levels have been undetectable for over a year.

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My breast cancer has been treated and currently shows no signs of the disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

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

Dose-limiting toxicities

Incidence of adverse events

Secondary study objectives

Chimeric antigen receptor (CAR) T-cell (T) 19/20 bispecific transgenic T-cell persistence

Clinical response

Duration of B-cell aplasia following CART19/20 infusion.

+5 more

Other study objectives

Analysis of proteins/cytokines (c-reactive protein (CRP), interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ)) concentration in peripheral blood following CART19/20 infusion.

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 (fludarabine, cyclophosphamide, CD19/CD20 T-cells)Experimental Treatment4 Interventions

CONDITIONING CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 60 minutes 5, 4, and 3 days before cell infusion. T-CELL INFUSION: Patients receive CD19/CD20 CAR-T cells IV on day 0. Patients with cytokine release syndrome may also receive tocilizumab IV on day 2 at the discretion of the clinical investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Cyclophosphamide

2010

Completed Phase 4

~2310