Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All subjects will be assigned to two Selinexor dose groups of 20 mg/week and 40 mg/week after receiving a single dose infusion of CT103A.

Selinexor, 20 mg/tablet, is a first-in-class, oral Selective-Inhibitor-of-Nuclear-Export (SINE) compound that impedes XPO-1which is a major nuclear export protein of macromolecular cargo frequently overexpressed in MM.

Selinexor

CT103A consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that containing a unique CAR structure with a fully human single-chain variable fragment (scFv).

CT103A

Chunrui Li

This study is a single-center, open Phase I study, to observe the effectiveness and safety of CT103A combined with different doses of Selinexor in patients with relapsed/refractory extramedullary multiple myeloma, and the pharmacokinetics of Selinexor and CT103A Kinetic and pharmacodynamic characteristics.

In this study, two dose groups of 20 mg/week and 40 mg/week will be set for Selinexor, and the dose of CT103A is 1.0×106 cells/Kg. Subjects in all dose groups will firstly receive a single dose infusion of CT103A, at least 1 month post infusion and platelet recovery to ≥50×109/L. Then subjects began to take Selinexor once a week for one year. Each dose group level will include 8-10 subjects, and a total of 16-20 subjects are expected to be enrolled.

The efficacy and safety, as well as the pharmacokinetic and pharmacodynamic characteristics of CT103A combined with different doses of Selinexor will be assessed in patients with relapsed/refractory extramedullary multiple myeloma. In this study, CT103A will be infused at the dose of 1.0×10\^6 cells/Kg, while Selinexor was set as two dosage groups of 20 mg/week and 40 mg/week. Subjects in all dose groups received a single infusion of CT103A, and at least 1 month after the infusion of CT103A, Selinexor was administered orally once a week for one year when platelet count recovered to ≥50×10\^9 /L. 8 to 10 subjects were enrolled at each dose group level, with a total of 16 to 20 subjects expected to be enrolled.

A Study of a Fully Human BCMA-targeting CAR (CT103A) Combined With Selinexor in Patients With Relapsed/Refractory Extramedullary Multiple Myeloma

Phase I Clinical Study of a Fully Human BCMA-targeting CAR (CT103A) Combined With Selinexor in the Treatment of Patients With Relapsed/Refractory Extramedullary Multiple Myeloma

The time from the start of CT103A treatment for the subjects to the first disease progression or death for any reason.

The percentage of subjects who achieved sCR、CR、VGPR、PR.

DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria

OS is measured from the date of the initial infusion of CT103A to the date of the participant's death.

MRD evaluation according to IMWG, including the proportion of subjects who achieved MRD negative and the duration of MRD negative.

Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after lymphodepletion and after infusion, those related to study drug and lymphodepletion, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity

The maximum transgene level at Cmax fo CT103A

The maximum transgene level at Tmax fo CT103A

Area under the curve of CT103A cells from time zero to Day 28 of CT103A

Area under the curve of CT103A cells from time zero to Day 90 of CT103A

The changes of concentration of Selinexor in peripheral blood will be assessed.

The concentration levels of CAR-T-related serum cytokines such as Ferritin and IL-6

HRQoL will be assessed by the European Organization for Cancer Research and Treatment Quality of Life Questionnaire (EORTC-QLQ-C30)

Appraisal of life quality of the subjects will be assessed by the Quality of Life Multiple Myeloma Module Questionnaire (QLQ-MY20)

Lymphocyte subsets will be assessed by FACS

The levels of Immunoglobulins in peripheral blood will be assessed to monitor changes at each time point

Nanjing IASO Biotechnology Co., Ltd.

Professor

CT103A autologous CAR-T cells will be infused at RP2D of 1.0 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy

Songbai Cai

Kaiyang Ding

Yongping Song

Jing Liu

Jianyong Li

Bing Chen

Zhenyu Li

He Huang

Kai Hu

Hanyun Ren

Xi Zhang

Peng Liu

Jianqing Mi

Lugui Qiu

Lugui Qiu, MD, PhD

Chunrui Li, MD, PhD

This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of CT103A in subjects with relapsed and refractory MM.

Leukapheresis procedure will be performed to manufacture CT103A chimeric antigen receptor (CAR) modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of CT103A at 1.0 x 10\^6 CAR+ T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after CT103A infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT103A infusion.

A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory Multiple Myeloma (FUMANBA-1)

Phase 1/2 Clinical Study on Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Development of an anti-CAR antibody response

The incidence of replication competent lentivirus (RCL)

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC

Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigators

Time from CT103A infusion to time of death due to any cause

Time from first response evaluated by an IRC or investigators to disease progression or death from any cause

Time from CT103A infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first

Time from CT103A infusion to first documentation of response evaluated by an IRC or investigators

Proportion of subjects who achieved MRD negative

Area under the curve of CAR T cells from time zero to Day 28

Area under the curve of CAR T cells from time zero to Day 90

soluble BCMA levels in peripheral blood of subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of a Fully Human BCMA-targeting CAR (CT103A) Combined With Selinexor in Patients With Relapsed/Refractory Extramedullary Multiple Myeloma	NCT05201118	Extramedullary ...	Selinexor CT103A	18 Years -	Tongji Hospital
A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory Multiple Myeloma (FUMANBA-1)	NCT05066646	Multiple Myelom...	CT103A	18 Years - 70 Years	Nanjing IASO Biotechnology Co., Ltd.
A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory Multiple Myeloma (FUMANBA-1)	NCT05066646	Multiple Myelom...	CT103A	18 Years - 70 Years	Nanjing IASO Biotechnology Co., Ltd.
A Phase 1/2 Study of a Fully Human BCMA-targeting CAR (CT103A) in Patients With Relapsed/Refractory Multiple Myeloma (FUMANBA-1)	NCT05066646	Multiple Myelom...	CT103A	18 Years - 70 Years	Nanjing IASO Biotechnology Co., Ltd.

Spots Global Cancer Trial Database for ct103a

Every month we try and update this database with for ct103a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ct103a

Every month we try and update this database with for ct103a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ct103a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.