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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 5 August 2020
See if I qualify
cancer
direct bilirubin
monoclonal antibodies
stem cell transplantation
lymphoma
monoclonal antibody therapy
oxygen saturation
anthracyclines
lenalidomide
monoclonal protein
b-cell lymphoma
follicular lymphoma
ibrutinib
idelalisib
conjugated bilirubin
biological factors
recurrent disease
venetoclax
diffuse large b-cell lymphoma
anthracycline
burkitt's lymphoma
tositumomab
richter syndrome
anti-cd20 monoclonal antibody
chemoimmunotherapy
pulse oximetry
large cell lymphoma
biologic agent
anti-cd20 antibody

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.

Details
Condition Diffuse Large B-Cell Lymphoma, MALT Lymphoma, marginal zone lymphoma, Waldenstrom's Macroglobulinemia, Lymphoproliferative Disorder, Chronic Lymphocytic Leukemia, lymphocytic leukemia, chronic, Chronic Lymphocytic Leukemia, Burkitt's Lymphoma, lymphocytic leukemia, chronic, marginal zone lymphoma, Primary Mediastinal Large B Cell Lymphoma, Transformed Follicular Lymphoma to Diffuse Large B Cell Lymphoma, Indolent Non-Hodgkin Lymphoma, Primary CNS Lymphoma
Age 18years - 100years
Treatment 19(T2)28z1xx CAR T cells
Clinical Study IdentifierNCT04464200
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Dose Escalation Phase
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 6 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
Dose Expansion phase
Cohort 1: same disease subtypes as in the Dose Escalation Phase
Cohort 2 (exploratory cohort) will include the following additional disease
histology
Patients with CLL
Refractory to or relapsed after at least 1 prior chemo or chemoimmunotherapies (e.g., FCR, BR) and 1 prior biologic agent (e.g. BTK, PI3K inhibitors, venetoclax) requiring further treatment, OR
Refractory to or relapsed after at least 2 prior biologic agents (e.g. Ibrutinib, idelalisib, venetoclax, except a single agent anti-CD20 monoclonal antibody) requiring further treatment
Patients with iNHL (FL, MZL, WM)
Refractory or relapsed after at least 2 lines of chemoimmunotherapy (including at least one course of anti-CD20 antibody), OR
Refractory or relapsed after at least 1 prior biologic agent (e.g., lenalidomide, ibrutinib, idelalisib)
Patients with Burkitt's lymphoma or transformed CLL to large cell lymphoma (i.e. Richter's transformation)
Refractory to or relapsed after at least 1 prior multiagent systemic chemo or chemoimmunotherapy

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
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
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cancer
direct bilirubin
monoclonal antibodies
stem cell transplantation
lymphoma
monoclonal antibody therapy
oxygen saturation
anthracyclines
lenalidomide
monoclonal protein
b-cell lymphoma
follicular lymphoma
ibrutinib
idelalisib
conjugated bilirubin
biological factors
recurrent disease
venetoclax
diffuse large b-cell lymphoma
anthracycline
burkitt's lymphoma
tositumomab
richter syndrome
anti-cd20 monoclonal antibody
chemoimmunotherapy
pulse oximetry
large cell lymphoma
biologic agent
anti-cd20 antibody

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