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

Running, not enrolling · Phase 1

Conditions studied: Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Transformed Follicular Lymphoma to Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Indolent Non-Hodgkin Lymphoma, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Burkitt's Lymphoma, Primary CNS Lymphoma

In brief

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.

Key facts

Study ID: NCT04464200
Run by: Memorial Sloan Kettering Cancer Center
People needed: 30
Starts: 2020-07-06
Expected to finish: 2026-07-01
Last updated by the study team: 2025-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Relapsed disease after 2 or more prior chemoimmunotherapies with at least one containing an anthracycline and CD20 directed therapy
Patients need to have radiographically documented disease

You may not qualify if…

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.
Prior CD19-directed therapy including CD19 CAR T cells is allowed, as long as expression of CD19 is confirmed by flow cytometry or immunohistochemistry.
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 the skin.
Patients with 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.

Where it is running

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

Full record on ClinicalTrials.gov

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