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

NCT05757700 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 22-401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

B-Cell Lymphoma; Large B-cell Lymphoma; DLBCL; High-grade B cell lymphoma; Mediastinal Large B-cell Lymphoma; TRAC-CAR T cells; Memorial Sloan Kettering Cancer Center; 22-401

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  The target toxicity rate for the MTD is

  up to 1 year

Study Arms (1)

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

EXPERIMENTAL

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

Biological: 19(T2)28z1xx TRAC T cell

Interventions

19(T2)28z1xx TRAC T cell 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Takeda: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jae Park, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: February 23, 2023
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)