Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915184
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Carsgen Therapeutics, Ltd.

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: CT053 Phase 1

Detailed Description:

This is an open label, multi-center, phase 1b clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; CT053) in patients with relapsed and or refractory multiple myeloma.

Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT053). Following manufacture of the drug product, subjects will receive lymphodepletion prior to CT053 infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving CT053 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Multi-center, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: CAR-BCMA T Cells
Phase 1b will include two parts, a dose escalation part to determine the recommended dose for the expansion part. During expansion patients will be treated with the recommended dose determined in the expansion part.
Biological: CT053
A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion
Other Name: CAR-BCMA T Cell Infusion




Primary Outcome Measures :
  1. Incidence of Treatment Related adverse events (AEs) [ Time Frame: day 1 - month 60 ]
    Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

  2. Identification of Maximum Tolerated Dose (MTD) [ Time Frame: day 1 - month 60 ]
    Incidence of dose-limiting toxicities (DLTs)


Secondary Outcome Measures :
  1. Evaluate the clinical efficacy of CT053 in patients with rrMM after a single administration of CT053 [ Time Frame: day 1 - month 60 ]
    Disease-specific response criteria including, but not limited to: complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, Progression Free Survival and Overall Survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily signed consent;
  2. Age of ≥ 18;
  3. Received sufficient prior lines of myeloma therapy;
  4. Received treatment with at least one proteasome inhibitor, one IMiD and daratumumab.
  5. The patients should have measurable disease per IMWG definition.
  6. Estimated life expectancy > 12 weeks;
  7. ECOG performance score 0-1;
  8. Patients should have reasonable CBC counts, renal and hepatic functions;
  9. Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
  10. 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 6 months after T cell infusion;
  11. Men must be willing to use effective and reliable method of contraception for at least 6 months after T cell infusion.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
  3. Any uncontrolled active infection;
  4. AEs from previous treatment that have not recovered;
  5. Patients who have had anti-BCMA therapy;
  6. Patients who have graft versus host disease (GvHD);
  7. Patients have received stem cell transplantation less than 12 weeks before leukapheresis;
  8. Patients have received any anti-cancer treatment before leukapheresis;
  9. Patients have received steroids before leukapheresis or lymphodepletion;
  10. 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;
  11. Patients have been administered live attenuated vaccine before leukapheresis or lymphodepletion;
  12. Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or CT053 CAR BCMA T cell;
  13. Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
  14. Patients have clinical significant pulmonary conditions;
  15. Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy;
  16. Patients with second malignancies in addition to MM are not eligible;
  17. Patients have central nervous system (CNS) metastases or CNS involvement;
  18. Patients have significant neurologic disorders;
  19. Patients are unable or unwilling to comply with the requirements of clinical trial;
  20. Patients have received major surgery prior to leukapheresis or prior to lymphodepletion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915184


Contacts
Layout table for location contacts
Contact: Hong Ma, MD CentralNumber clinicalUS@carsgen.com

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Hospital Not yet recruiting
Phoenix, Arizona, United States, 85054
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana Farber Cancer Center Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Recruiting
Rochester, Minnesota, United States, 55905
United States, Texas
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 76021
MD Anderson Not yet recruiting
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada, MSG 2C4
Sponsors and Collaborators
Carsgen Therapeutics, Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Shaji Kumar, MD Mayo

Layout table for additonal information
Responsible Party: Carsgen Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT03915184     History of Changes
Other Study ID Numbers: CT053-MM-02
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carsgen Therapeutics, Ltd.:
CAR-T
Carcinoma
Carcinoma, Multiple Myeloma
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases