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19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers

A Phase I Study of CD19-Targeted 19(T2)28z1xx Chimeric Antigen Receptor (CAR) Modified T Cells in Adult Patients With Relapsed or Refractory B-cell Malignancies

NCT04464200•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the safety of 19(T2)28z1xx CAR T cells in people with relapsed/refractory B-cell cancers. The researchers will try to find the highest dose of 19(T2)28z1xx CAR T cells that causes few or mild side effects in participants. Once they find this dose, they can test it in future participants to see if it is effective in treating their relapsed/refractory B-cell cell cancers. This study will also look at whether 19(T2)28z1xx CAR T cells work against participants' cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years of age
•Creatinine ≤2.0 mg/100 ml, direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN)
•Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
•Histologically confirmed DLBCL and large B cell lymphoma, including
•* DLBCL, not otherwise specified (NOS), or
•* Transformed DLBCL from follicular lymphoma, or
•* High-grade B cell lymphoma (excluding Burkitt's lymphoma), or
•* Primary mediastinal large B cell lymphoma AND
•* Chemotherapy refractory disease, defined as a failure to achieve at least a partial response or disease progression within 12 months to the last therapy, OR
•* Disease progression or recurrence in ≤12 months of prior autologous stem cell transplant (ASCT), OR
+2 more criteria

Exclusion Criteria

•ECOG performance status ≥2.
•Patients with active CNS disease
•Pregnant or lactating women. Women and men 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 ECHO or MUGA scan.
•Patients with the following cardiac conditions will be excluded:
•* New York Heart Association (NYHA) stage III or IV congestive heart failure
•* Myocardial infarction ≤6 months prior to enrollment
•* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration ≤6 months prior to enrollment
•Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.
•Patients with prior allogeneic hematopoietic stem cell transplant are eligible, if more than 3 months from transplant and if patients have no active graft versus host disease (GvHD) and not on systemic immunosuppressive therapy.
+5 more criteria

Locations (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

July 6, 2020

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

August 24, 2025

Enrollment

ACTUAL participants

Conditions

Diffuse Large B Cell LymphomaPrimary Mediastinal Large B Cell LymphomaTransformed Follicular Lymphoma to Diffuse Large B Cell LymphomaChronic Lymphocytic LeukemiaIndolent Non-Hodgkin LymphomaMarginal Zone LymphomaWaldenstrom MacroglobulinemiaBurkitt's LymphomaPrimary CNS Lymphoma

Interventions

19(T2)28z1xx CAR T cells

DRUG

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

View study

RECRUITINGPHASE1

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers

Inclusion Criteria

Exclusion Criteria

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL

Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers

Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?