Neoplasms

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All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

CAR-T cells

Lung-Ji Chang, ph.D

Vitaly Dubov, MD

The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.

Multiple myeloma (MM) is the second most common malignant hematological cancer in the world, which begins with the malignant proliferation of plasma cells in bone marrow. It has been a difficult disease to treat, and most patients will eventually relapse, especially for those with high-risk genotypes. At present, the therapeutic drugs for MM include glucocorticoids, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies. Among those, immunotherapy has been proven to be a revolutionary treatment with great potential of curing this disease. The frequently targeted MM antigens include CD38, CD138, CD19 and BCMA, and recently, GPRC5D.

BCMA, the B cell maturation antigen, also known as CD269 or TNFRSF17, is a member of tumor necrosis factor receptor superfamily, which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells. It has been an ideal target for MM immunotherapy.

GPRC5D, the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein, is highly expressed on the surface of plasma cells but not in other healthy cells, and thus it has become a potential target for the treatment of MM. The expression of GPRC5D is unrelated to BCMA, so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients.

This trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D, and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients. Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body.

Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy

The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0

Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion by measuring the CAR copies in the blood

Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma by examination of known tumor indicators

The No.2 Clinical Hospital of the Ministry of Health

Shenzhen Geno-Immune Medical Institute

Subjects who meet the enrollment conditions will receive intravenous infusion of anti--GPRC5D CAR-T Cells after lymphodepleting therapy.

This is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of CAR-T cells:

Dose level one: 3.0×10\^6 /kg±20%; Dose level two:6.0×10\^6 /kg±20%; Dose level three:1.0×10\^7 /kg±20%.

Anti-GPRC5D CAR-T cells infusion

Sanbin Wang, MD

Sanbin Wang, Doctor

It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed and refractory(r/r) multiple myeloma(MM).

This open label, single-arm, Phase I study aims to evaluate the efficacy and safety of Anti-GPRC5D CAR-T in subjects with relapsed and refractory(r/r) multiple myeloma(MM). A leukapheresis procedure will be performed to manufacture Anti-GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-GPRC5D CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.

Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM

An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of Relapsed / Refractory(r/r) Multiple Myeloma(MM)

The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.

Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of CAR-T cells after optimal supportive treatment, which were discussed with the investigator and determined to be associated or likely to be associated with the infusion.

Overall Response Rate (ORR) is defined as the proportion of subjects achieving strict complete remission(sCR), complete response(CR), very good partial response(VGPR） and partial response(PR).

Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion

Progression-free survival(PFS) refers to the time from cell reinfusion to the first assessment of tumor progression or death from any cause.

Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-T cells until death (from any cause).

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Module 1:

Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.

AZD0305

AstraZeneca Clinical Study Information Center

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM. This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents.

The study includes dose escalation and dose expansion phases. This study will enroll subjects with RRMM who received at least 3 prior lines of treatment including at least one proteasome inhibitor (PI), one immunomodulator (IMiD), and an anti-CD38 antibody. Subjects will be administered AZD0305 intravenously.

This protocol has a modular design, with the potential for future treatment arms, study parts, or modules to be added via protocol amendments. Module 1 will include Phase Ia (Dose escalation), and Phase Ib (Dose expansion/optimization).

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Lmmunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Relapsed or Refractory Multiple Myeloma

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes, any death not clearly due to the underlying disease or extraneous causes, pre-defined haematological and non-haematological toxicities

Number of patients with adverse events and serious adverse events by system organ class and preferred term

The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria

The time from the date of first response until date of disease progression or death in the absence of disease progression

The time from first dose until IMWG defined disease progression or death

The time from the date of the first dose of study treatment until death due to any cause

Area under the plasma concentration-time curve

Maximum observed plasma concentration of the study drug

Time to maximum observed plasma concentration of the study drug

A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time

The number and percentage of participants who develop ADAs

The time from date of first response until date of disease progression or death in the absence of disease progression

The time from randomization until IMWG defined disease progression or death

The time from randomization until death due to any cause

AstraZeneca

This is a open label, single arm clinical trial.

After enrollment, subjects complete the PBMC apheresis, then complete the Lymphocyte clearance, and then receive the dose climbing test: 1×10e6/kg，3×10e6/kg，6×10e6/kg.

GPRC5D-CAR-T

Huang He

This is a single-arm, open-label, dose-escalation study to evaluate the safety, tolerability, cellular kinetics and initial efficacy of CAR-T cell therapy targeting GPRC5D in multiple myeloma subjects who have failed the standard treatments.

A Study of CAR-T Cells Targeting GPRC5D in the Treatment of r/r Multiple Myeloma

A Single Arm, Open Label Clinical Study of CAR-T Cells Targeting GPRC5D in the Treatment of Relapsed / Refractory Multiple Myeloma(POLARIS)

Proportion of subjects with complete or partial remission

The percentage of patients with remission and stable disease after treatment in the total evaluable cases.

The time from the first assessment of remission or partial remission of the tumor to the first assessment of disease progression or death from any cause;

The time from cell reinfusion to the first assessment of tumor progression or death from any cause

The time from the cell reinfusion to death due to any cause.

OriCell Therapeutics Co., Ltd.

Zhejiang University

Chief Physician

BMS-986393

Alnuctamab

Mezigdomide

Iberdomide

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

Susan Bal, Site 0008

Site 0002

Myo Htut, Site 0028

Site 0005

Scott Solomon, Site 0006

Site 0011

Site 0027

Site 0001

Site 0010

Site 0004

Site 0007

Jingmei Hsu, Site 0022

Divaya Bhutani, Site 0009

Sham Mailankody, Site 0012

Site 0025

Krina Patel, Site 0003

Site 0013

Site 0024

Bristol-Myers Squibb

The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM).

A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Leukemia

Hematologic Neoplasms

Leukemia, Plasma Cell

Plasma Cell Leukemia

Dose Escalation followed a dose expansion.

Single group of patients for each indication (rrMM, RRpPCL).

CT071

CARsgen US

A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.

This is an open-label, multicenter, Phase 1/2 trial of CT071 in adult participants with relapsed or refractory multiple myeloma (RRMM) or relapsed or refractory primary plasma cell leukemia (RRpPCL).

The study will be conducted in two phases. Phase 1 of the study will be dose escalation followed by dose expansion. After recommended Phase 2 dose is identified in Phase 1, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo apheresis to collect cells for manufacture of the CAR-T cells. Following the manufacture of the CAR-T cells, subjects will receive lymphodepletion prior to CAR T-cell infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving CAR T-cell infusion for reasons other than death or meeting the early termination criteria, will be asked to undergo a 15-year long-term follow-up.

Phase 1; Dose escalation followed by dose expansion Phase 2; Single group of each indication will be dosed at the recommended dose level from Phase 1.

Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL

A Phase 1/2 Open Label Study to Evaluate the Safety and Efficacy of CT071, an Autologous Anti-GPRC5D CAR T, in Relapsed/Refractory Multiple Myeloma (RRMM) or Relapsed/Refractory Primary Plasma Cell Leukemia (RRpPCL)

Frequency, type, and severity of AEs (SAEs, AESIs, laboratory abnormalities).

Objective response rate (ORR) per IMWG by IRC read; percentage of participants achieving confirmed PR or better per IMWG 2016 consensus criteria.

Overall Response Rate/Best Overall Response Rate by investigator (by IMWG stringent complete response/sCR, complete response/CR, very good partial response/VGPR, and partial response/PR by IRC and investigator assessment).

Duration of Response by IMWG (stringent complete response/sCR, complete response/CR, very good partial response/VGPR, and partial response/PR by IRC and investigator assessment).

Progression Free Survival by investigator assessment

Percentage of patients with anti-CT071 drug antibodies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma	NCT06429150	Multiple Myelom... Plasmacytoma	CAR-T cells	18 Years - 80 Years	Shenzhen Geno-Immune Medical Institute
Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM	NCT05739188	Multiple Myelom... Multiple Myelom...	Anti-GPRC5D CAR...	18 Years - 75 Years	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma	NCT06106945	Multiple Myelom...	AZD0305	18 Years -	AstraZeneca
A Study of CAR-T Cells Targeting GPRC5D in the Treatment of r/r Multiple Myeloma	NCT05016778	Multiple Myelom...	GPRC5D-CAR-T	18 Years - 75 Years	Zhejiang University
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma	NCT06121843	Multiple Myelom...	BMS-986393 Alnuctamab Mezigdomide Iberdomide	18 Years -	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma	NCT06429150	Multiple Myelom... Plasmacytoma	CAR-T cells	18 Years - 80 Years	Shenzhen Geno-Immune Medical Institute
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma	NCT06121843	Multiple Myelom...	BMS-986393 Alnuctamab Mezigdomide Iberdomide	18 Years -	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL	NCT06333509	Multiple Myelom... Primary Plasma ...	CT071	18 Years -	CARsgen Therapeutics Co., Ltd.

Spots Global Cancer Trial Database for gprc5d

Every month we try and update this database with for gprc5d 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 gprc5d

Every month we try and update this database with for gprc5d 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 gprc5d 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.