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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 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.

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04464200
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jae Park, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being 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
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 19(T2)28z1xx CAR T cells

Cohorts of 3-6 patients will be infused with escalating doses of 19(T2)28z1XX CAR T cells to establish the RP2D. There are 4 planned flat-dose levels: 25x10^6, 50 x 10^6, 100 x 10^6 and 200 x 10^6 CAR T cells and one de-escalation dose: 12.5 x 10^6 CAR T cells. A standard 3+3 dose escalation design will be implemented starting from dose 1.

Interventions

Drug: - 19(T2)28z1xx CAR T cells

2-7 days following the completion of the conditioning chemotherapy, patients will receive the CAR- T cells by IV infusion over 1-3 days depending on the dose level and formulation of the final CAR- T cells.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Jae Park, MD

parkj6@mskcc.org

646-608-3743

The content provided by NBTS on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Terms, Conditions & Privacy