NCT03915184

Brief Summary

A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
105mo left

Started Sep 2019

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
2 countries

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Sep 2019Dec 2034

First Submitted

Initial submission to the registry

April 3, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Expected
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

5.3 years

First QC Date

April 3, 2019

Last Update Submit

December 18, 2023

Conditions

Multiple Myeloma

Keywords

CAR-TCarcinomaCarcinoma, Multiple MyelomaCT053zevor-cel

Outcome Measures

Primary Outcomes (3)

  • Incidence of Treatment Related adverse events (AEs)

    Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

    Day 1 - Month 60

  • Identification of Maximum Tolerated Dose (MTD)

    Incidence of dose-limiting toxicities (DLTs)

    Day 1 - Month 60

  • Objective response rate

    Objective response rate (ORR) per IMWG by IRC read

    Day 1 - Month 60

Secondary Outcomes (6)

  • Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM

    Day 1 - Month 60

  • Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment

    Day 1 - Month 60

  • Evaluate zevor-cel PK profile

    Day 1 - Month 60

  • Evaluate ADA profile

    Day 1 - Month 60

  • Evaluate HRQoL in patients with rrMM from baseline up to study completion

    Day 1 - Month 60

  • +1 more secondary outcomes

Other Outcomes (3)

  • BCMA bone marrow expression and soluble BCMA expression in blood

    Day 1 - Month 60

  • Cytokine profiling

    Day 1 - Month 60

  • zevor-cel product profiling vs clinical safety and efficacy

    Day 1 - Month 60

Study Arms (1)

CAR-BCMA T Cells

EXPERIMENTAL

Phase 1b will include a dose escalation followed by an expansion cohort to determine the recommended dose for the expansion part. After recommended Phase 2 is determined, patients in Phase 2 will be treated.

Biological: zevor-cel

Interventions

zevor-celBIOLOGICAL

A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion

Also known as: CAR-BCMA T Cell Infusion
CAR-BCMA T Cells

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily signed consent;
  • Age of ≥ 18 and \< 80 years;
  • Received sufficient prior lines of myeloma therapy;
  • Received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body.
  • The patient must be refractory to the last line of therapy.
  • The patients should have measurable disease per IMWG definition.
  • Estimated life expectancy \> 12 weeks;
  • ECOG performance score 0-1;
  • Patients should have reasonable CBC counts, renal and hepatic functions;
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
  • Women of childbearing age must undergo a serum pregnancy test with negative results before screening, and are willing to use effective and reliable method of contraception for at least 12 months after T cell infusion;
  • Men must be willing to use effective and reliable method of contraception for at least 12 months after T cell infusion.

You may not qualify if:

  • Pregnant or lactating women;
  • HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
  • Any uncontrolled active infection;
  • AEs from previous treatment that have not recovered;
  • Patients who have had anti-BCMA therapy;
  • Patients who have graft versus host disease (GvHD);
  • Patients have received stem cell transplantation one year before leukapheresis;
  • Patients have received any anti-cancer treatment before leukapheresis;
  • Patients have received steroids before leukapheresis or lymphodepletion;
  • Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage;
  • Patients have been administered live attenuated vaccine before leukapheresis or lymphodepletion;
  • Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or zevor-cel CAR BCMA T cell;
  • Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
  • Patients have clinical significant pulmonary conditions;
  • Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States

Location

Mayo

Rochester, Minnesota, 55905, United States

Location

TriStar CMC

Nashville, Tennessee, 37203, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 76021, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Methodist Hosptial

Houston, Texas, 77030, United States

Location

Huntsman Cancer Center

Salt Lake City, Utah, 84112, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Princess Margaret Hospital

Toronto, Ontario, MSG 2C4, Canada

Location

MeSH Terms

Conditions

Multiple MyelomaCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesNeoplasms, Glandular and Epithelial

Study Officials

  • Shaji Kumar, MD

    Mayo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 16, 2019

Study Start

September 25, 2019

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2034

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations

CA(1)US(12)