Phase 1a/1b Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells (MC10029) in Subjects With Relapsed or Refractory BAFFR-Expressing B-Cell Hematologic Malignancies

This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.

Start Date18 Mar 2024

Sponsor / Collaborator

Mayo Clinic

NCT05963217 / RecruitingPhase 1IIT

Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

This is a Phase 1/1b, open-label, dose-escalation study to evaluate the safety and the efficacy of anti-CD19 chimeric antigen receptor (CAR) (TBI-2001) for relapsed or refractory CD19+ B-cell lymphoma Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).

Start Date26 Jul 2023

Sponsor / Collaborator

University Health Network

[+1]

NCT05828589 / RecruitingPhase 1

A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies

This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminstered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion."

Start Date20 Jun 2023

Sponsor / Collaborator

BeiGene Ltd.

100 Clinical Results associated with Refractory Small Lymphocytic Lymphoma

100 Translational Medicine associated with Refractory Small Lymphocytic Lymphoma

0 Patents (Medical) associated with Refractory Small Lymphocytic Lymphoma

Literatures (Medical) associated with Refractory Small Lymphocytic Lymphoma

11 Feb 2019·Cureus

Toxic Encephalopathy After Relapsed Indolent Non-Hodgkin’s Lymphoma Following Abrupt Discontinuation of Idelalisib (ZYDELIG®)

Author: Urella, Madhulika ; Assad, Salman ; Shenouda, Mina ; Dotson, Jennifer

Idelalisib is a delta isoform-specific, phosphoinositide 3-kinase (PI3-K) inhibitor. It has been used as a single agent for the treatment of relapsed or refractory small lymphocytic lymphoma (SLL), follicular non-Hodgkin's lymphoma (NHL), and in combination with rituximab for patients with chronic lymphocytic leukemia (CLL). We present a case of a 77-year-old man diagnosed with SLL and was treated with multiple chemotherapeutic regimens in the past. Considering multiple relapses, he was started on idelalisib monotherapy almost 12 months ago. The treatment was stopped due to worsening neutropenia as well as mixed response on the scans. Almost, within one week of stopping the medication, he presented with complaints of altered mental status, hematuria, and worsening of generalized lymphadenopathy. This time, the patient was started on venetoclax (BCL-2 inhibitor) and rituximab which he is tolerating well without any complications.

01 Apr 2016·Therapeutic Advances in HematologyQ2 · MEDICINE

The role of idelalisib in the treatment of relapsed and refractory chronic lymphocytic leukemia

Q2 · MEDICINE

ReviewOA

Author: Nair, Kruti Sheth ; Cheson, Bruce

Idelalisib is a first in class, delta isoform specific, PI3-kinase inhibitor. Based on its high level of efficacy and acceptable safety profile, this oral drug has been approved by the US Food and Drug Administration as a single agent for the treatment of relapsed or refractory small lymphocytic lymphoma, and follicular non-Hodgkin lymphoma, and in combination with rituximab for patients with chronic lymphocytic leukemia. Adverse effects of particular concern include diarrhea, pneumonitis, and transient elevations of hepatic transaminase levels. Efforts to improve on the activity of this drug have included combinations with standard chemotherapy agents, such as bendamustine, and other targeted therapies, including checkpoint inhibitors. However, other combinations have been associated with life-threatening and fatal toxicities. Thus, the development of such regimens should be conducted carefully in the context of a clinical research study. Idelalisib has a vital role as second-line therapy for chronic lymphocytic leukemia, especially for patients with high-risk disease and multiple comorbidities, and studies are exploring the use of this agent as front-line therapy to improve the outcome of patients with indolent B-cell malignancies.

01 Jun 2013·International Journal of Surgical PathologyQ4 · MEDICINE

Composite Peripheral T-cell Lymphoma Not Otherwise Specified, and B-cell Small Lymphocytic Lymphoma Presenting With Hemophagocytic Lymphohistiocytosis

Q4 · MEDICINE

Review

Author: Xu, Mina ; Alomari, Ahmed ; Hui, Pei

We report a case of a 68-year-old female patient who developed hemophagocytic lymphohistiocytosis (HLH) secondary to peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS) that developed in the setting of treatment-resistant B-cell small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL). The patient’s B-cell lymphoma had a good initial response to chemotherapy for 4 years, after which it became less responsive and was thought to have undergone transition to a higher-grade lymphoma. Different regimens of chemoradiotherapy were then tried with modest response until the patient presented 3 years later with signs and symptoms of HLH. The patient died 1 month later, and an autopsy was performed. Significant para-aortic lymphadenopathy and splenomegaly were found. Microscopic, immunohistochemical and molecular evaluations confirmed the presence of composite B-cell and T-cell lymphoma in the para-aortic enlarged lymph nodes. Bone marrow examination showed hemophagocytosis, and the liver demonstrated infiltration by activated macrophages with hepatocellular necrosis. This report highlights the importance of searching for a possible underlying T-cell lymphoma in light of HLH. Different theories have been proposed to explain the rare occurrence of concurrent B- and T-cell lymphomas, but the development of HLH in this patient highlights the importance of immune dysregulation as a proposed mechanism to explain some cases of composite lymphomas. A review of the literature and discussion of the relative merits of these hypotheses are presented in the context of this case.

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