Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

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

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

19(T2)28z1xx TRAC T cell

Jae Park, MD

M. Lia Palomba, MD

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.

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

A Phase I Study of T-cell Receptor Alpha Constant (TRAC) Locus Integrated CD19-Targeted 19(T2)28z1xx Chimeric Antigen Receptor (CAR) Modified T Cells in Adult Patients With CD19+ Relapsed or Refractory Large B-Cell Lymphoma

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.

Takeda

Memorial Sloan Kettering Cancer Center

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Follicular

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Pharmaceutical Solutions

Antirheumatic Agents

Oxaliplatin

Antibodies

Dexamethasone

Cytarabine

Rituximab

Dexamethasone acetate

Antibodies, Bispecific

Immunoglobulins

Single arm study - All patients undergo same treatment with Epcoritamab for salvage and consolidation phases.

Epcoritamab (Epcor) is a bispecific antibody recognizing the T-cell antigen CD3 and the B-cell antigen CD20. Epcor is a supplied as a concentrate for solution for intended subcutaneous injection. The dose must be prepared by a qualified pharmacist using aseptic technique.

Epcoritamab-Salvage treatment phase:

2-3 cycles of R-DHAOx therapy (rituximab, dexamethasone, cytarabine, oxaliplatin), given every 21 days combined with Epcoritamab subcutaneous weekly dosing (priming 0.16mg Cycle 1 Day 1, intermediate 0.8mg cycle 1 day 8, full dose 48mg from cycle 1 day 15 onwards)

Epcoritamab Consolidation phase:

6 cycles (28 days each) of subcutaneous Epcoritamab, commencing between 6-12 weeks post ASCT.

Epcoritamab dosing and timing for consolidation:

* Cycle 1 Day 1: Priming (0.16mg) dose
* Cycle 1 Day 8: intermediate (0.8mg) dose
* Cycle 1 Day 15: full dose 48mg
* Cycle 1 Day 22, Cycle 2-3 Days 1, 8, 15 and 22: 48mg
* Cycles 4 to 6 - Days 1 and 15 (fortnightly dosing): 48mg

Epcoritamab

The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:

* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant?
* Is consolidation epcoritamab after ASCT deliverable and safe?
* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?
* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.

Participants will undergo three phases in this trial:

1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab
2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.
3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.

Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL

A Trial to Assess the Safety and Efficacy of Epcoritamab-containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma

Individual patient data will not be shared publicly. Aggregate patient data and final results will be presented in the final report.

Time to event outcome measured in days from commencement of each treatment subset (salvage chemotherapy and Epcoritamab/ASCT/ Epcoritamab re-treatment) to date of first to occur out of reduced partial response (PR) after C2, commencement of non-protocolised cancer treatment, progression or death from any cause.

Rate of adverse events according to CTCAE criteria v 6.0 expressed as a number and proportion.

Defined as achievement of at least a partial response to treatment according to Lugano criteria i.e. achievement of a PR or CR at any time during study participation

Defined as achievement of CR at any time during study according to Lugano criteria

Defined as the time from commencement of study treatment until death from any cause

Defined as the time from commencement of study treatment until disease progression or death from any cause, following Epcoritamab-chemotherapy salvage, transplant and maintenance. Time to event outcome measured in months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of 19(T2)28z1xx TRAC-Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Lymphoma	NCT05757700	B-Cell Lymphoma Large B-cell Ly... DLBCL, Nos Gene... High-grade B Ce... Mediastinal Lar...	19(T2)28z1xx TR...	18 Years -	Memorial Sloan Kettering Cancer Center
Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL	NCT06287398	DLBCL - Diffuse... High-grade B-ce... High Grade B-Ce... DLBCL, Nos Gene... High Grade B-Ce... Follicular Larg... Follicular Larg...	Epcoritamab	18 Years -	Australasian Leukaemia and Lymphoma Group

Spots Global Cancer Trial Database for dlbcl, nos genetic subtypes