Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03486067
• Other study ID #: CC-93269-MM-001
• Secondary ID: U1111-1210-63252
• Status: Recruiting
• Phase: Phase 1
• Start date: April 3, 2018
• Est. completion date: August 5, 2029

Study information

• Verified date: April 2024
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

Description:

The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 5, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of multiple myeloma with relapsed and refractory disease
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Must have measurable disease as determined by the central laboratory

Exclusion Criteria:

• Symptomatic central nervous system involvement of multiple myeloma
• Prior autologous stem cell transplant = 3 months prior
• Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning = 12 months prior
• History of concurrent second cancers requiring active, ongoing systemic treatment Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CC-93269
Specified dose on specified days

Locations

Country	Name	City	State
Germany	Universitatsklinikum Erlangen	Erlangen
Germany	Local Institution - 303	Hamburg
Germany	Local Institution - 302	Heidelberg
Germany	Klinikum rechts der Isar TUM	München
Germany	Local Institution - 0506	Munich
Germany	Local Institution - 0507	Munich
Germany	University of Tubingen	Tuebingen
Italy	Azienda Ospedaliera Papa Giovanni Xxiii	Bergamo
Italy	Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)	Meldola
Italy	Istituto Clinico Humanitas	Milan
Japan	Shonan Kamakura General Hospital	Kamakura
Japan	Local Institution - 604	Kashiwa
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	Local Institution - 602	Nagoya-shi	Aichi
Japan	Local Institution - 606	Ogaki
Japan	Japanese Red Cross Medical Center	Shibuya-ku	Tokyo
Spain	Hospital Universitari Germans Trias i Pujol ICO Badalona	Barcelona
Spain	Vall d Hebron University Hospital.	Barcelona
Spain	Hospital General Gregorio Maranon	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Universtario Marques de Valdecilla	Santander
Spain	Hospital de la Fe	Valencia
Spain	Hospital Universitario Doctor Peset	Valencia
Sweden	Local Institution - 504	Gothenborg
Sweden	Skanes Universitetssjukhus Lund	Lund
Sweden	Karolinska University Hospital, Huddinge	Stockholm
Sweden	Akademiska Hospital Uppsala	Uppsala
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Henry Ford Medical Center - New Center One	Detroit	Michigan
United States	Yale Cancer Center	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai Mount Sinai West	New York	New York
United States	University Of California San Francisco Medical Center	San Francisco	California
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Japan,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)	Number of participants with Adverse Events	Up to approximately 63 months
Primary	Dose Limiting Toxicity (DLT)	Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.	Up to 60 months
Primary	Non-Tolerated Dose (NTD)	Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.	Up to 60 months
Primary	Maximum Tolerated Dose (MTD)	Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.	Up to 60 months
Secondary	Overall Response Rate (ORR)	Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.	Up to 60 months
Secondary	Time to Response	Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).	Up to 60 months
Secondary	Duration of Response	Is defined as the time from the earliest date of documented response (= PR) to the first documented disease progression or death, whichever occurs first.	Up to 60 months
Secondary	Progression Free Survival	Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.	Up to 60 months
Secondary	Overall Survival	Is defined as the time from the first dose of CC-93269 to death from any cause.	Up to 60 months
Secondary	Pharmacokinetics - Cmax	Maximum serum concentration of drug	Up to 60 months
Secondary	Pharmacokinetics - Cmin	Minimum serum concentration of drug	Up to 60 months
Secondary	Pharmacokinetics - AUC	Area under the curve	Up to 60 months
Secondary	Pharmacokinetics - tmax	Time to peak (maximum) serum concentration	Up to 60 months
Secondary	Pharmacokinetics - t1/2	Terminal Half-life	Up to 60 months
Secondary	Pharmacokinetics - CL	Apparent total body clearance	Up to 60 months
Secondary	Pharmacokinetics - Vss	Volume of distribution at steady-state	Up to 60 months
Secondary	Pharmacokinetics - accumulation index of alnuctamab	Accumulation ratio of drug	Up to 60 months
Secondary	Presence and frequency of anti-drug antibodies (ADA)	Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies	Up to 60 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting