RECRUITING

Iomab-ACT: a Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

Conditions

B-ALL DLBCL B ALL Dlbcl-Ci DLBCL Unclassifiable DLBCL, Nos Genetic Subtypes DLBCL Activated B-Cell Type DLBCL Germinal Center B-Cell Type Diffuse Large B-cell Lymphoma HGBL HGBL, Nos CD19+ B-cell malignancy 131-I apamistamab B-cell malignancy Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.

Official Title

Iomab-ACT: a Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

Quick Facts

Study Start:2021-02-02

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04512716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment. * Age ≥ 18 years of age * Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula * Direct bilirubin ≤2.0 mg/dL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy * Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry. * Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator: 1. Absolute neutrophil count ≥0.5k/µL, 2. Platelets ≥30k/µL, 3. Hemoglobin ≥7g/dL. * ECOG performance status 0-2.	* ECOG performance status ≥3. * Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished. * Impaired cardiac function (LVEF \<40%) as assessed by echocardiogram or MUGA scan during screening * Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible * Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible * Patients with following cardiac conditions will be excluded: 1. New York Heart Association (NYHA) stage III or IV congestive heart failure 2. Myocardial infarction ≤6 months prior to enrollment 3. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration 4. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20% * Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions: 1. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded. 2. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded. * Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible. * Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin. * Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible. * Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study. * Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)

Inclusion Criteria

Exclusion Criteria

* While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment.
* Age ≥ 18 years of age
* Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula
* Direct bilirubin ≤2.0 mg/dL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy
* Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
* Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator:
1. Absolute neutrophil count ≥0.5k/µL,
2. Platelets ≥30k/µL,
3. Hemoglobin ≥7g/dL.
* ECOG performance status 0-2.

* ECOG performance status ≥3.
* Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
* Impaired cardiac function (LVEF \<40%) as assessed by echocardiogram or MUGA scan during screening
* Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible
* Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible
* Patients with following cardiac conditions will be excluded:
1. New York Heart Association (NYHA) stage III or IV congestive heart failure
2. Myocardial infarction ≤6 months prior to enrollment
3. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
4. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%
* Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:
1. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded.
2. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.
* Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.
* Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.
* Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.
* Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.
* Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)

Contacts and Locations

Study Contact

Mark B Geyer, MD

CONTACT

646-608-3745

geyerm@mskcc.org

Neeta Pandit-Taskar, MD

CONTACT

212-639-3046

pandit-n@mskcc.org

Principal Investigator

Mark B Geyer, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Mark B Geyer, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-02

Study Completion Date2025-01

Study Record Updates

Study Start Date2021-02-02

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

CD19+ B-cell malignancy
131-I apamistamab
B-cell malignancy
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

B-ALL
DLBCL
B ALL
Dlbcl-Ci
DLBCL Unclassifiable
DLBCL, Nos Genetic Subtypes
DLBCL Activated B-Cell Type
DLBCL Germinal Center B-Cell Type
Diffuse Large B-cell Lymphoma
HGBL
HGBL, Nos