19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers
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ClinicalTrials.gov Identifier: NCT04464200 |
Recruitment Status :
Recruiting
First Posted : July 9, 2020
Last Update Posted : January 26, 2023
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: 19(T2)28z1xx CAR T cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | This is a standard phase I open-label dose-escalation trial. Cohorts of 3-6 patients will be infused with escalating doses of 19(T2)28z1XX CAR T cells to establish the MTD. There are 4 planned dose levels with one additional de-escalation dose level. A 3+3 design will be used to establish the RP2D. Once the RP2D is determined, the study will open to Dose Expansion phase and up to 12 patients with B-cell non-Hodgkin lymphoma (same eligibility criteria as the dose-escalation phase). |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 6, 2020 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | July 2024 |

Arm | Intervention/treatment |
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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.
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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. |
- Recommended Phase II Dose (RP2D) [ Time Frame: 28 days post infusion ]Dose escalation will use a 3+3 design. DLT-evaluable participants are defined as those participants who were infused with 19(T2)28z1XX CAR T cells and who were monitored for toxicities during the first 28 days of post infusion.
- overall response rate (ORR) [ Time Frame: 2 years ]Response and progression of the disease will be evaluated in this study using the Lugano Classification

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464200
Contact: Jae Park, MD | (646) 608-2091 | parkj6@mskcc.org | |
Contact: M. Lia Palomba, MD | 646-608-3711 |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Jae Park, MD 646-608-2091 | |
Contact: M. Lia Palomba, MD 646-608-3711 | |
Principal Investigator: Jae Park, MD |
Principal Investigator: | Jae Park, MD | Memorial Sloan Kettering Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT04464200 |
Other Study ID Numbers: |
20-167 |
First Posted: | July 9, 2020 Key Record Dates |
Last Update Posted: | January 26, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
19(T2)28z1XX CAR T cells 20-167 |
Burkitt Lymphoma Lymphoma Lymphoma, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large B-Cell, Diffuse Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia |
Leukemia, B-Cell Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |