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CAR T-cell Therapy

CAR T-Cell Therapy for B-Cell Lymphoma

Phase 1

Waitlist Available

Led By Jae Park, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry

Age ≥ 18 years of age

Must not have

Patients with presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible

Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of 19(T2)28z1xx CAR T cells in people with relapsed/refractory B-cell cancers. The goal is to find the highest dose that causes few or mild side effects. Future trials will test if it is effective in treating relapsed/refractory B-cell cell cancers.

Who is the study for?

Adults with certain types of B-cell cancers that haven't responded to previous treatments, including specific lymphomas and leukemias. Participants must have measurable disease, adequate organ function, and agree to use effective contraception. Excluded are those with poor performance status, active CNS disease, recent heart issues or uncontrolled infections.

What is being tested?

The trial is testing the safety of a new therapy called 19(T2)28z1xx CAR T cells for relapsed/refractory B-cell cancers. It aims to find the highest dose with minimal side effects and will also assess if this treatment effectively combats participants' cancer.

What are the potential side effects?

While not detailed in the provided information, typical CAR T cell therapy side effects may include flu-like symptoms, fever, fatigue, difficulty breathing, rapid heartbeat and potential neurological events like confusion or seizures.

Eligibility Criteria

Inclusion Criteria

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

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My oxygen levels are 92% or higher on room air.

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I am 18 years old or older.

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My lymphoma has not responded well to previous treatments, including chemotherapy.

Exclusion Criteria

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

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I do not have severe neurological disorders like epilepsy or major brain injuries.

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I do not have any ongoing serious infections.

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My heart's pumping ability is below 40%.

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I do not have HIV or active hepatitis B or C.

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I have severe heart failure.

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I need assistance with my daily activities.

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I have an active brain or spinal cord disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

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

Recommended Phase II Dose (RP2D)

Secondary study objectives

overall response rate (ORR)

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: 19(T2)28z1xx CAR T cellsExperimental Treatment1 Intervention

Cohorts of 3-6 patients will be infused with escalating doses of 19(T2)28z1XX CAR T cells to establish the RP2D. There are 4 planned flat-dose levels: 25x10\^6, 50 x 10\^6, 100 x 10\^6 and 200 x 10\^6 CAR T cells and one de-escalation dose: 12.5 x 10\^6 CAR T cells. A standard 3+3 dose escalation design will be implemented starting from dose 1.

0 / 10Eligibility criteria met