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

Phase 1

Active, not recruiting

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

• Registration Number: NCT04464200
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-7-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - Age = 18 years of age<br><br> - Creatinine =2.0 mg/100 ml, direct bilirubin =2.0 mg/100 ml, AST and ALT =3.0x upper<br> limit of normal (ULN)<br><br> - Adequate pulmonary function as assessed by =92% oxygen saturation on room air by<br> pulse oximetry.<br><br> - Histologically confirmed DLBCL and large B cell lymphoma, including<br><br> - DLBCL, not otherwise specified (NOS), or<br><br> - Transformed DLBCL from follicular lymphoma, or<br><br> - High-grade B cell lymphoma (excluding Burkitt's lymphoma), or<br><br> - Primary mediastinal large B cell lymphoma AND<br><br> - Chemotherapy refractory disease, defined as a failure to achieve at least a<br> partial response or disease progression within 12 months to the last therapy,<br> OR<br><br> - Disease progression or recurrence in =12 months of prior autologous stem cell<br> transplant (ASCT), OR<br><br> - Relapsed disease after 2 or more prior chemoimmunotherapies with at least one<br> containing an anthracycline and CD20 directed therapy<br><br> - Patients need to have radiographically documented disease<br><br>Exclusion Criteria:<br><br> - ECOG performance status =2.<br><br> - Patients with active CNS disease<br><br> - Pregnant or lactating women. Women and men of childbearing age should use effective<br> contraception while on this study and continue for 1 year after all treatment is<br> finished.<br><br> - Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan.<br><br> - Patients with the following cardiac conditions will be excluded:<br><br> - New York Heart Association (NYHA) stage III or IV congestive heart failure<br><br> - Myocardial infarction =6 months prior to enrollment<br><br> - History of clinically significant ventricular arrhythmia or unexplained<br> syncope, not believed to be vasovagal in nature or due to dehydration =6 months<br> prior to enrollment<br><br> - Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.<br><br> - Patients with prior allogeneic hematopoietic stem cell transplant are eligible, if<br> more than 3 months from transplant and if patients have no active graft versus host<br> disease (GvHD) and not on systemic immunosuppressive therapy.<br><br> - Prior CD19-directed therapy including CD19 CAR T cells is allowed, as long as<br> expression of CD19 is confirmed by flow cytometry or immunohistochemistry.<br><br> - Patients with uncontrolled systemic fungal, bacterial, viral or other infection are<br> ineligible.<br><br> - Patients with any concurrent active malignancies as defined by malignancies<br> requiring any therapy other than expectant observation or hormonal therapy, with the<br> exception of squamous and basal cell carcinoma of the skin.<br><br> - Patients with presence of clinically significant neurological disorders such as<br> epilepsy, generalized seizure disorder, severe brain injuries are ineligible.<br><br> - Any other issue which, in the opinion of the treating physician, would make the<br> patient ineligible for the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recommended Phase II Dose (RP2D)

Secondary Outcome Measures

Name	Time	Method
overall response rate (ORR)