Study of 19(T2)28z1xx TRAC-Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Lymphoma

NCT ID: NCT05757700

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-23
• Study Completion Date: 2026-02-23

Brief Summary

The purpose of this research is to evaluate if study therapy, 19(T2)28z1xx TRAC-chimeric antigen receptor (CAR) T cells, may be an effective treatment for people with relapsed/refractory B-cell lymphoma. Researchers will also evaluate if this study therapy is safe, and to look for the highest dose that causes few or mild side effects in participants.

Conditions

B-Cell Lymphoma; Large B-cell Lymphoma; DLBCL, Nos Genetic Subtypes; High-grade B Cell Lymphoma; Mediastinal Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma

Participants have histologically confirmed DLBCL and large B cell lymphoma. Participants will be treated with escalating doses of modified T cells.

Group Type: EXPERIMENTAL

19(T2)28z1xx TRAC T cell

Intervention Type: BIOLOGICAL

Participants will be treated with escalating doses of modified T cells.

Dose level -1: 3 x 10^6 Dose level 1: 10 x 10^6 Dose level 2: 30 x 10^6 Dose level 3: 100 x 10^6

Interventions

19(T2)28z1xx TRAC T cell

Participants will be treated with escalating doses of modified T cells.

Dose level -1: 3 x 10^6 Dose level 1: 10 x 10^6 Dose level 2: 30 x 10^6 Dose level 3: 100 x 10^6

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years of age
• Creatinine ≤1.5 mg/100 ml or creatinine clearance ≥ 45ml/min/m2 , 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

Exclusion Criteria

• ECOG performance status ≥2.
• 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.
• Active CNS disease
• 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 commercially approved or investigational CD19 CAR T cells or BiTEs 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Park, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

22-401

Identifier Type: -

Identifier Source: org_study_id