Heart and Blood Diseases

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Vascular Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Hemostatic Disorders

Blood Coagulation Disorders

Lymphoproliferative Disorders

Paraproteinemias

Neoplasm, Residual

Hematologic Diseases

Hemorrhagic Disorders

Neoplasms by Histologic Type

Blood Protein Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Up to three dosing cohorts of CYNK-001 given on Day 2 or Days 2, 7, 14 post ASCT. Once MTD has been determined, the Expansion cohort will commence.

CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.

CYNK-001

Adrian Kilcoyne, MD

This study will find the maximum tolerated dose (MTD) of CYNK-001 which contain NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given post Autologous Stem Cell Transplant (ASCT). The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating Multiple Myeloma.

The study will utilize a 3+3 open label design, and will enroll up to three dosing cohorts of CYNK-001 given on Day 2 or Days 2, 7, 14 post ASCT. Once MTD has been determined, the Expansion cohort will commence.

Natural Killer Cell (CYNK-001) Infusions in Adults With Multiple Myeloma

A Phase I Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK 001) in Multiple Myeloma Patients Following Autologous Stem Cell Transplant in the Front-line Setting.

Safety Assessment of Dose-Limiting Toxicity (DLT)

Celularity Incorporated

Patients will be be treated with BCMA targeted prime CAR-T cells

BCMA targeted prime CAR-T cells

Zhi Yang, PhD

Sanbin Wang, MD

Cheng Qian, PhD

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma

Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG

In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry

In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR

In vivo (bone marrow) quantity of clonal plasma cells

DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)

PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)

OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored)

Chongqing Precision Biotech Co., Ltd

Lymphoma

Leukemia

Lymphoma, Mantle-Cell

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Leukemia, Plasma Cell

Recurrence

Lymphoma, Non-Hodgkin

Disease Attributes

Lymphosarcoma

Mantle Cell Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Plasma Cell Leukemia

SNS01-T

John A Lust, MD, PhD

The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.

The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.

Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)

Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies

Safety and Tolerability assessed by frequency, severity, and duration of treatment-related adverse events, changes in vitals signs, physical exams and lab values

Cmax, area under curve, Tmax. Performed on Weeks 1, 3, 6, 10, 14, 18

IMWG criteria, changes in M-protein, etc. for myeloma and plasma cell leukemia; Lymphoma response criteria, CT/PET scans for B cell lymphoma

Senesco Technologies, Inc.

Patients will be be treated with BCMA CAR-T cells

A single infusion of BCMA CAR-T cells will be administered intravenously.

BCMA CAR-T cells

Yingzi Zhang

Ying Xiang, MD

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG

In vivo (bone marrow and peripheral blood) rate of BCMA CAR-T cells were determined by means of flow cytometry

In vivo (bone marrow and peripheral blood) quantity of BCMA CAR copies were determined by means of qPCR

PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)

OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)

BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma

Behaviors and Mental Disorders

Hematologic Neoplasms

Quality of Life

A systematic reassessment of geriatric parameters

A systematic reassessment of geriatric parameters will be performed at 3 and 6 months post-inclusion.

Comprehensive Geriatric Assessment

Laurent BALARDY, MD

Sabine LE FLOCH

Laurent BALARDY

Stéphanie LOZANO

Loïc YSEBAERT

Aurore PERROT

The aim of the study is to assess the prevalence of functional decline in elderly patients treated with chemotherapy or immunochemotherapy for lymphoid hematologic malignancies. For this purpose, each patient benefits at inclusion (D0) of a standardized gerontological evaluation, and 3 and 6 months post-inclusion.

The aim of this study is to contribute to the improvement of the hematological management of elderly patients. Indeed, the majority of hematological malignancies are diagnosed in subjects aged 65 years and over. Hematologists are therefore increasingly confronted with the complexity of managing elderly patients. The high prevalence of comorbidities and/or geriatric syndromes (cognitive disorders, malnutrition, loss of functional autonomy, etc.) contributes to the great heterogeneity of this population and to the complexity of therapeutic decisions.

The comprehensive geriatric assessment (CGA), recommended by the International Society of of Onco-Geriatrics (SIOG), allows to better understand this heterogeneity and to define an individualized management. Numerous studies have demonstrated the value of the CGA in predicting the risk of treatment toxicity and morbidity in geriatric hematology. However, beyond life expectancy, the maintenance of quality of life and/or functional autonomy represent major parameters to be integrated into the therapeutic decision. These two parameters are not sufficiently taken into account in hematology clinical trials. In the vast majority of these studies, the criteria of interest remain purely hematological (overall survival, toxicity, relapse-free survival, etc.). This approach may even be responsible for an increased risk of toxicity when the chemotherapy protocols proposed to elderly patients are based on the same objectives as those for younger subjects. It therefore seems essential to change the paradigm by integrating major geriatric criteria into the methodology of clinical trials of hematological malignancies in elderly patients.

The main objective of our study is therefore to evaluate the prevalence of functional decline in a population of elderly patients treated with chemotherapy or immuno-chemotherapy for lymphoid hemopathies. For this purpose, each patient benefits at inclusion (D0) of a standardized gerontological evaluation, and 3 and 6 months post-inclusion.

Impact of Chemotherapeutic Treatments in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy

Impact of Chemotherapeutic Treatments on Functional Autonomy and Quality of Life in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy

Rate of patients with functional decline at 6 months. Functional decline was defined as a loss of 0.5 points or more on the Activities Daily Living scale (ADL) at 6 months compared with inclusion.

A loss of at least 1 point in the Short Physical Performance Battery (SPPB) score

Events of Toxicity will be assessed according to NCI-CTCAE v5

Ratio of institutionalized patients to total patients

Ratio of the number of patients who died early

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Natural Killer Cell (CYNK-001) Infusions in Adults With Multiple Myeloma	NCT04309084	Multiple Myelom... Neoplasm, Plasm... Neoplasms by Hi... Neoplasms Hemostatic Diso... Vascular Diseas... Cardiovascular ... Paraproteinemia... Blood Protein D... Hematologic Dis... Hemorrhagic Dis... Lymphoprolifera... Immunoprolifera... Immune System D... Antineoplastic ... Analgesics, Non... Analgesics Sensory System ... Peripheral Nerv... Physiological E...	CYNK-001	18 Years - 75 Years	Celularity Incorporated
a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma	NCT04776330	Multiple Myelom... Neoplasm, Plasm... Multiple Myelom...	BCMA targeted p...	18 Years - 75 Years	Chongqing Precision Biotech Co., Ltd
a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma	NCT04776330	Multiple Myelom... Neoplasm, Plasm... Multiple Myelom...	BCMA targeted p...	18 Years - 75 Years	Chongqing Precision Biotech Co., Ltd
Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)	NCT01435720	Multiple Myelom... Multiple Myelom... Mantle Cell Lym... Diffuse Large B... Other B Cell Ly... Plasma Cell Leu...	SNS01-T SNS01-T SNS01-T SNS01-T	18 Years -	Senesco Technologies, Inc.
Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma	NCT04272151	Multiple Myelom... Multiple Myelom... Neoplasm, Plasm...	BCMA CAR-T cell...	18 Years - 75 Years	Chongqing Precision Biotech Co., Ltd
BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma	NCT04271644	Multiple Myelom... Neoplasm, Plasm... Multiple Myelom...	BCMA CAR-T cell...	18 Years - 75 Years	Chongqing Precision Biotech Co., Ltd
BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma	NCT04271644	Multiple Myelom... Neoplasm, Plasm... Multiple Myelom...	BCMA CAR-T cell...	18 Years - 75 Years	Chongqing Precision Biotech Co., Ltd
Impact of Chemotherapeutic Treatments in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy	NCT05101759	Neoplasm, Plasm... Lymphoma	Comprehensive G...	75 Years -	University Hospital, Toulouse

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