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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

Subjects will take ICP-022 150mg once daily (QD).

ICP-022

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.

A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia

A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)

The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria

Beijing InnoCare Pharma Tech Co., Ltd.

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)

All Drugs and Chemicals

Amino Acids

Antibodies

Immunoglobulins

Proteasome Inhibitors

Tyrosine

Participants with R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor will receive BGB-11417 at a standard dose, given orally once daily.

Participants with R/R disease to anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor will receive BGB-11417 at a standard dose, given orally once daily.

Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive BGB-11417 at a standard dose, given orally once daily.

BGB-11417

Study Director

This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.

This study will test whether BGB-11417 can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) who have not responded well to conventional treatments. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience.

BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated with many cancers. Blocking the action of BCL2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including WM. This study will enroll approximately 85 patients. All patients will receive BGB-11417 orally as a tablet.

The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years. Treatments will continue until participants experience worsening disease status, too many side effects, or withdraw consent.

Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia

An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia

MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the Independent Review Committee (IRC).

MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator (Cohorts 1, 2, and 3) and by the IRC (Cohorts 2 and 3).

DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC and by the investigator.

CR + VGPR is defined as the percentage of participants who achieve CR or VGPR, as assessed by the IRC and by the investigator.

ORR is defined as the percentage of participants with minor response (MR) or better, as assessed by the IRC and by the investigator.

PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC and by the investigator.

Time to major response is defined as the time from start of study treatment to the first documentation of major response, as assessed by the IRC and by the investigator.

OS is defined as the time from first study drug administration to the date of death due to any cause.

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities, physical examination results, and vital signs.

HRQoL based on participant-reported outcomes using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item (NFLymSI-18) Version 4. The questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.

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
A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia	NCT04440059	Waldenstrom's M... Waldenstrom's M...	ICP-022	18 Years -	Beijing InnoCare Pharma Tech Co., Ltd.
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 Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia	NCT05952037	Waldenstrom Mac... Waldenstrom's M... Waldenstrom's M...	BGB-11417	18 Years -	BeiGene
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 Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia	NCT04440059	Waldenstrom's M... Waldenstrom's M...	ICP-022	18 Years -	Beijing InnoCare Pharma Tech Co., Ltd.

Spots Global Cancer Trial Database for waldenstrom's macroglobulinemia refractory