Symptoms and General Pathology

All Conditions

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Heart and Blood Diseases

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Lymphoma

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Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Leukemia, Hairy Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

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Lymphoma, Non-Hodgkin

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Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Hairy Cell Leukemia

Dendritic Cell Tumor

Blastic Plasmacytoid Dendritic Cell

Patients previously treated with MB-102 CAR-T cell investigational product.

Patients previously treated with MB-106 CAR-T cell investigational product.

No investigational product will be administered.

Prior MB-102 CAR-T cell investigational product.

Prior MB-106 CAR-T cell investigational product.

Bruce Dezube, M.D.

A long-term follow-up study to assess safety and efficacy in patients previously treated with Mustang Bio chimeric antigen receptor (CAR)-T cell investigational products.

Non-interventional, multi-center, long-term follow-up study of subjects previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study. Subjects who enroll will be monitored for a total of up to 15 years from the time of their last investigational product infusion.

Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.

A Long-term Follow-up Study in Patients Previously Treated With Mustang Bio, Inc. CAR-T Cell Investigational Products

Incidence and characterization of adverse events (AEs) related to prior treatment with a Mustang Bio CAR-T cell investigational product received in a Mustang Bio sponsored clinical study.

Detection of replication competent lentivirus (RCL).

Mustang Bio

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Tisagenlecleucel

Ibrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

Single-arm study investigating combination of ibrutinib and Tisagenlecleucel treatment

ibrutinib and Tisagenlecleucel

Michael Dickinson

This is an open label, multi-center, single-arm, phase II study investigating the efficacy and safety of the combination of ibrutinib and Tisagenlecleucel in twenty patients with relapsed or refractory Mantle Cell Lymphoma (MCL) or who had sub-optimal response to standard therapy in the presence of TP53 mutation.

Clinical Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma

A Phase II, Open-Label, Single Arm Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma

Through monitoring of the incidence, nature and severity of adverse events (graded according to NCI CTCAE v5.0), Serious Adverse Events, dose interruptions and dose reductions of ibrutinib

Measured through aggregate measure of peripheral blood/or bone marrow flow cytometry, PCR and ctDNA

By monitoring for patient death due to any cause

Novartis

Peter MacCallum Cancer Centre, Australia

MB-106, single intravenous infusion up to 3.3 x 10e7 chimeric antigen receptor t-cells (CAR-T cells)/kg

MB-106, single intravenous infusion up to 3.3 x 10e7 CAR-T cells/kg

MB-106, single intravenous infusion. Dose based upon outcome Phase 1.

T-cells derived from autologous leukapheresis that are genetically modified.

MB-106

Premier Research

Harmonie Strohl

Jeremy S. Abramson, M.D.

M. Lia Palomba, MD

Kaitlyn Burrows

Patrick Reagan, MD

Cancer Awareness Department

SCCA Immunotherapy Intake

Mazyar Shadman, MD

Study to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients with Relapsed or Refractory B-Cell NHL or CLL

This is a multicenter, Phase 1/2, open-label, non-randomized study of MB-106 in patients ≥18 years of age with selected CD20-expressing malignancies.

In both the Phase 1 and Phase 2 portions of the study, all patients must have evidence of CD20 expression.

In Phase 1, patients will be enrolled in 1 of 3 arms, based on their primary diagnosis, as follows:

* Arm 1: Patients with aggressive B-cell non-Hodgkin lymphoma (NHL) including, but not limited to, diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL).
* Arm 2: Patients with indolent NHL including, but not limited to, follicular lymphoma (FL).
* Arm 3: Patients with chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL).

In Phase 1, escalating MB-106 dose levels will be tested independently in each arm using a 3+3 design.

A total of up to 18 patients are anticipated to be treated in each independent arm in Phase 1, including 6 patients at the maximum tolerated dose (MTD; highest dose level at which ≤1 of 6 patients experiences a dose-limiting toxicity \[DLT\]), prior to proceeding to the Phase 2 portion of the study for each respective arm, where a total of up to 71 patients will participate in each independent arm.

An assessment of the safety and tolerability of the dose will be made by the Safety Review Committee (SRC) based on the data from the 28-day DLT observation period.

An SRC composed of Principal Investigators and Sponsor representatives will review the safety of each dose level for each arm prior to enrollment at the next dose level in the Phase 1 dose escalation part of study. This process will be repeated for each dose level within each arm until the MTD has been reached, and the recommended Phase 2 dose (RP2D) has been established for that arm.

In Phase 2, the following specific arms of relapsed or refractory CD20-positive B-cell NHL or CLL patients will be treated with MB-106 at the respective RP2D for each arm. Each arm will initially include up to 20 patients:

* Arm 1 Expansion (E): Relapsed or refractory DLBCL, including high-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements, primary mediastinal large B-cell lymphoma and transformed FL.
* Arm 2E: Relapsed or refractory FL.
* Arm 2E-Basket: Relapsed or refractory B-cell NHL subtypes that have progressed after available therapies. This "basket" arm will include but will not be limited to MCL, marginal zone lymphoma (MZL), Waldenstrom's macroglobulinemia (WMG), Burkitt and Burkitt-like lymphoma, and hairy cell leukemia (HCL).
* Arm 3E: Relapsed or refractory CLL/SLL

Arms 1E, 2E and 3E of Phase 2 will have an interim efficacy analysis for futility prior to completion of recruitment to the arm. Arm 2E-Basket will be summarized descriptively only. Safety data from all arms will also be provided at this interim timepoint to the Data Safety Monitoring Board (DSMB) for review. Based on the results of the interim analysis, an additional 51 patients may be added to each of these arms.

Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL

A Phase 1/2, Open Label, Multicenter Study to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory CD20+ B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

The safety, tolerability, and feasibility of MB-106 in patients with relapsed or refractory CD20+ B-cell NHL or CLL.

Incidence of treatment-emergent AEs (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs), therapy-related AEs, Grade 3 or 4 TEAEs, TEAEs with an outcome of death (i.e., Grade 5 TEAEs), and TEAEs leading to study discontinuation.

To determine the RP2D of MB-106 in each of the 3 arms in patients with relapsed or refractory CD20+ B-cell NHL or CLL.

The RP2D will be the highest MB-106 dose in each arm that is associated with fewer than 2 cases of DLT in 6 patients.

To assess the efficacy of MB-106 as measured by objective response rate (ORR) according to the Lugano Classification for Lymphomas for patients with NHL. For patients with CLL, ORR will be assessed according to the 2018 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group. ORR will be determined by the percentage of patients achieving complete remission (CR) or partial remission (PR) as their best response. Radiology scans will be assessed for response by an Independent Central Reviewer.

To assess the efficacy of MB-106 as measured by objective response rate (ORR) according to the Lugano Classification for Lymphomas for patients with NHL. For patients with CLL, ORR will be assessed according to the 2018 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group for patients with CLL. ORR will be determined by percentage of patients achieving complete remission (CR) or partial remission (PR) as their best response.

To assess the efficacy of MB-106, as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

To assess the total number of patients with minimal residual disease (MRD) in CLL patients.

To assess the safety, tolerability, and feasibility of MB-106 in patients with relapsed or refractory CD20+ B-cell NHL or CLL.

Incidence of treatment-emergent AEs (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs), therapy-related AEs, Grade 3 or 4 TEAEs, TEAEs with an outcome of death (i.e., Grade 5 TEAEs), and TEAEs leading to study discontinuation.

Total number of patients with minimal residual disease (MRD) in CLL patients.

National Cancer Institute (NCI)

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Peripheral T-cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Anti-Infective Agents

Doxycycline

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Carla Casulo, MD

The purpose of this study is to determine whether doxycycline is effective in the treatment of relapsed Non Hodgkin Lymphomas (NHL).

The long-term objective of this proposal is to develop more effective and less toxic therapeutic approaches for relapsed and refractory Non Hodgkin Lymphomas (NHL). Given the incurability of indolent lymphomas, innovative strategies for treatment are needed. For aggressive lymphomas such as Diffuse Large B Cell Lymphoma (DLBCL), novel treatments are particularly relevant since one third of patients have disease that will relapse or is refractory to standard therapy. Outcomes for this remaining group of patients are very poor. To address this unmet need, we have identified the antimicrobial agent doxycycline as a novel drug repurposed for lymphoma treatment based on results from a small molecule screen against Diffuse Large B Cell Lymphoma (DLBCL). Through preclinical work in his laboratory, my basic science collaborator Dr. Jiyong Zhao has found that doxycycline inhibits proliferation and survival in both activated B cell (ABC) type and germinal center B (GCB) type Diffuse Large B Cell Lymphoma (DLBCL) cell lines, as well as in Burkitt lymphoma (BL) and follicular lymphoma (FL) cell lines. Based on this preliminary data, we propose an open label, single center phase II study of doxycycline in patients with relapsed Non Hodgkin Lymphomas (NHL). We have selected a dose and schedule (200 mg BID by mouth daily) based on maximum antimicrobial dose use, and acceptance of tolerability in several studies. The planned correlative studies should help to identify potential biomarkers for response to doxycycline, such as plasma matrix metalloproteinase 9 (MMP9), and provide further insight into potential mechanisms of doxycyline action hypothesized from results of prior laboratory studies.

A Phase II Study of Doxycycline in Relapsed NHL

To investigate change in plasma matrix metalloproteinase 9 (MMP9) levels as a biomarker of treatment response; to assess plasma matrix metalloproteinase 9 (MMP9) expression by immunohistochemistry (IHC) and correlate to response in order to test the hypothesis that elevated intratumoral levels of plasma matrix metalloproteinase 9 (MMP9) can predict response to doxycycline. To assess activation/expression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kb) and Signal transducer and activator of transcription 3 (STAT 3) pathways in archived tumor by immunohistochemistry (IHC) to predict response or resistance to doxycycline.

Overall response rate is defined as the percentage of patients with disease progression. Progression is defined as:

* Appearance of a new lesion on fluorodeoxyglucose (FDG)-positron emission tomography or computerized tomography
* ≥50% increase in sum of the product of the node dimensions (SPD) of more than one node or in greatest diameter of any previously identified node \>1 cm in its short axis from nadir.
* To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.
* At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.

Progression free survival is defined as the percentage of patients with stable disease or no death. Stable disease is defined as less than a partial response but is not progressive disease. Partial Response (PR)-At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses as determined byFDG-PET for CT scan. No increase should be observed in the size of other nodes, liver, or spleen. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients should be considered partial responders.

University of Rochester

Assistant Professor

Doxycycline 200 mg twice daily

Doxycycline

Age, Categorical

Gender

United States

Region of Enrollment

Carla Casulo

Overall Response Rate

Data was collected on all patients who were enrolled.

Percentage of Patients With Progression Free Survival

No data displayed because Outcome Measure has zero total participants analyzed

Exploratory Objective

Overall Study

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Bortezomib

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

bortezomib 1.3mg/m\^2 i.v. on days 1, 4, 8 and 11 of each 28-day cycle fludarabine 25mg/m\^2 i.v. on days 1\~3 of each 28-day cycle cyclophosphamide i.v. on days 1\~2 of each 28-day cycle

Combination of Bortezomib, Fludarabine and Cyclophosphamide

Huiqiang Huang

Xiaoxiao Wang

This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40 recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib, fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL progression.

This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40 recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib, fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL progression.

This study consists of three phases: screening/baseline phase, treatment phase and follow-up phase after the end of treatment.

At screening/baseline phase, investigators obtain informed consent form, check the inclusion/exclusion criteria and then collect the following data: demographics, medical history data, vital signs, ECG, MRI/CT/B-ultrasound/X-ray examinations, physical examination, laboratory examinations, pregnancy test (only female) and bone marrow biopsy and aspiration. Pathological diagnosis of mantle cell lymphoma should be established by lymph node biopsy or other tumor histopathological examination and immunophenotyping. At the same time, ECOG-performance status, Fact/GOG-Ntx questionnaire and NF-κB activity will be assessed.

During treatment period, patients will be treated with bortezomib, fludarabine and cyclophosphamide in a 28-day cycle. Patients achieve complete response (CR) or partial response (PR) can receive up to six cycles of VF (C) treatment, while those continue stable disease (SD) will be stopped after 4-cycle treatment and those with progressive disease (PD) will also be stopped after 2-cycle treatment. Due to adverse events, patients may receive reductions or deviate from the intended dose and duration of VF (C) treatment. These adjustments must be in accordance with the regulations in the protocol about the dose and time adjustment.

Maximum tolerated dose (MTD) of cyclophosphamide will be determined in accordance with the standard "3+3" method, testing three dose levels, 150mg/m2, 200mg/m2 and 250mg/m2. Cyclophosphamide dose escalation test will be conducted in the first cycle, with every three patients in a group. Patients' enrollment will be competed among different sites, but further step should be taken only after the 3 patients in one group complete the first cycle, their efficacy and safety have been completely evaluated, and the notification of going to next step by a CRO company. Subjects involved in the cyclophosphamide dose escalation test will continue initial cyclophosphamide dose during the entire study, except for possible dose adjustment determined by investigators due to DLT. After ascertaining MTD, new patients will be administrated with cyclophosphamide at the MTD. According to the dose escalation diagram, up to 18 patients will be involved in dose escalation phase. Subjects who discontinue the treatment due to causes other than DLT in the first cycle should be replaced by new participants to enter dose escalation test. DLT is defined as: a grade 4 neutropenia lasting longer than 7 days, a grade 4 thrombocytopenia, a neutropenic fever, or a grade 3 or above non-hematological toxicity (except for nausea, vomiting and alopecia); a grade 3 or above nausea, vomiting or diarrhea is considered as DLT only if still observed after treatment. Please refer to dose escalation diagram to conduct dose escalation trial.

Subjects will be followed up for 24 weeks after the end of chemotherapy. In this study, the primary efficacy endpoints are maximum tolerated dose (MTD) of cyclophosphamide in combination treatment with bortezomib and fludarabine, complete response rate (CR + CRu), overall response rate (ORR). Main indicators will be evaluated every 2 cycles in the treatment period and every 12 weeks in follow-up period.

Concomitant medications within 2 week before enrollment and during the study process need to be documented. All adverse events will be reported from the time a signed and dated informed consent form is obtained until 30 days following the last dose of study drug.

Combination of Bortezomib, Fludarabine and Cyclophosphamide Treat Recurrent Mantle Cell Lymphoma

Phase 1 and 2 Study of Combination Treatment of Bortezomib, Fludarabine and Cyclophosphamide in Patients With Recurrent Mantle Cell Lymphoma

The International Working Group (IWG) published the guidelines for response criteria for lymphoma in 1999. These response criteria are based on the reduction in the size of the enlarged lymph node as measured by CT scan and the extent of bone marrow involvement that is determined by bone marrow aspirate and biopsy.

Maximum tolerated dose (MTD) of cyclophosphamide will be determined in accordance with the standard "3+3" method, testing three dose levels, 150mg/m\^2, 200mg/m\^2 and 250mg/m\^2. Cyclophosphamide dose escalation test will be conducted in the first cycle, with every three patients in a group. Patients' enrollment will be competed among different sites, but futher step should be taken only after the 3 patients in one group complete the first cycle, their efficacy and safety have been completely evaluated, and the notification of going to next step by a CRO company.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.	NCT05645744	Blastic Plasmac... Chronic Lymphoc... Small Lymphocyt... Waldenstrom's M... Follicular B-ce... B-cell Lymphoma... Mantle Cell Lym... Hairy Cell Leuk... Diffuse Large B... Waldenstrom's M... Mantle Cell Lym...	Prior MB-102 CA... Prior MB-106 CA...	18 Years -	Mustang Bio
Clinical Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma	NCT04234061	Mantle Cell Lym...	ibrutinib and T...	18 Years -	Peter MacCallum Cancer Centre, Australia
Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL	NCT05360238	Follicular B-ce... Mantle Cell Lym... Mantle Cell Lym... Small Lymphocyt... Waldenstrom's M... Waldenstrom's M... Chronic Lymphoi... B-cell Lymphoma...	MB-106	18 Years -	Mustang Bio
Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL	NCT05360238	Follicular B-ce... Mantle Cell Lym... Mantle Cell Lym... Small Lymphocyt... Waldenstrom's M... Waldenstrom's M... Chronic Lymphoi... B-cell Lymphoma...	MB-106	18 Years -	Mustang Bio
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.	NCT05645744	Blastic Plasmac... Chronic Lymphoc... Small Lymphocyt... Waldenstrom's M... Follicular B-ce... B-cell Lymphoma... Mantle Cell Lym... Hairy Cell Leuk... Diffuse Large B... Waldenstrom's M... Mantle Cell Lym...	Prior MB-102 CA... Prior MB-106 CA...	18 Years -	Mustang Bio
Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL	NCT05360238	Follicular B-ce... Mantle Cell Lym... Mantle Cell Lym... Small Lymphocyt... Waldenstrom's M... Waldenstrom's M... Chronic Lymphoi... B-cell Lymphoma...	MB-106	18 Years -	Mustang Bio
A Phase II Study of Doxycycline in Relapsed NHL	NCT02086591	Adult Diffuse L... Mantle Cell Lym... Lymphoma, Folli... Marginal Zone B... Malignant Lymph... Waldenstrom Mac... Small Lymphocyt... Chronic Lymphoc... T-Cell Lymphoma	Doxycycline	18 Years -	University of Rochester
Combination of Bortezomib, Fludarabine and Cyclophosphamide Treat Recurrent Mantle Cell Lymphoma	NCT01322776	Mantle Cell Lym...	Combination of ...	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for mantle cell lymphoma recurrent