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Radioimmunotherapy

Radioimmunotherapy + CAR T-cell Therapy for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Phase < 1

Recruiting

Led By Mark B Geyer, 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

Patients with B-cell acute lymphoblastic leukemia or B lymphoblastic lymphoma (ALL) or chronic myeloid leukemia (CML) in lymphoid blast crisis: ("B-ALL patients")

Patients with Philadelphia chromosome-negative B-cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy.

Must not have

ECOG performance status ≥3.

Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to give CAR T cells, using a lower dose of radiation to prepare the patient's body. They want to find the maximum tolerated dose of the new method.

Who is the study for?

Adults with relapsed or refractory B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma, who have tried and not responded to previous treatments. They must have a certain level of organ function, no severe heart conditions, and cannot be pregnant. Those with active infections or other serious health issues are excluded.

What is being tested?

The trial is testing the combination of a radioactive antibody called 131-I apamistamab followed by CAR T-cell therapy in patients with specific types of blood cancer. The goal is to find the highest dose that patients can tolerate without too many side effects.

What are the potential side effects?

Potential side effects may include reactions related to radioactivity exposure from 131-I apamistamab such as nausea and thyroid issues, as well as those associated with CAR T-cell therapy like fever, difficulty breathing, confusion, and weakness.

Eligibility Criteria

Inclusion Criteria

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

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I have B-cell acute lymphoblastic leukemia or chronic myeloid leukemia in blast crisis.

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My B-cell ALL did not respond to or has returned after chemotherapy.

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My B-ALL or DLBCL cancer has returned or is not responding to treatment.

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My oxygen levels are 92% or higher without extra oxygen.

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My leukemia did not respond to advanced treatment.

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My cancer has spread to my bones or I have a tumor that shows up on PET scans.

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I am 18 years old or older.

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I have signs of cancer remaining before receiving CAR T-cell therapy.

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I have been diagnosed with a type of lymphoma called diffuse large B-cell.

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My kidneys are functioning well enough to filter waste.

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My cancer affects my B-cells, is CD19 positive, and has not responded to treatment.

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I can take care of myself and perform daily activities.

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My DLBCL or HGBL cancer did not respond to 2+ treatments including anthracycline and CD20 therapy.

Exclusion Criteria

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

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I have significant difficulty in performing daily activities.

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I have a severe heart condition with very low heart pump function.

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I am not on systemic therapy for an autoimmune disease.

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I am not currently on systemic therapy for graft versus host disease after a transplant.

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I do not have any ongoing serious infections.

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

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My heart condition severely limits my daily activities.

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I do not have antibodies against the BC8 treatment.

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My heart's pumping ability is below 40%.

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I do not have any serious heart conditions.

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I have a history of serious irregular heartbeats or fainting spells not caused by dehydration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after treatment 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 and maximum tolerated dose of 131-I apamistamab, when given in combination with 19-28z CAR T-cells for treatment of relapsed or refractory B-cell ALL or DLBCL