Dose Exploration Study OF JWCAR129 BCMA-Targeted CART for RRMM

  • STATUS
    Recruiting
  • End date
    Dec 27, 2024
  • participants needed
    24
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 27 January 2021

Summary

This is an open-label, Phase 1 dose exploration study to evaluate the safety and tolerability and to determine recommended Phase 2 dose(s) of JWCAR129, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma.

Details
Condition Safety and Efficacy
Treatment JWCAR129
Clinical Study IdentifierNCT04677452
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

18 years old and above
Signed the Informed Consent Form
Diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen). Subjects must be refractory to the last anti-myeloma treatment regimen prior to entering the study
Autologous hematopoietic stem cell transplantation
A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or in combination. Subjects must have undergone at least 2 consecutive cycles of treatment for each regimen unless progressive disease was the best response to the regimen
Anti-CD38 (eg, daratumumab) as part of a combination regimen or as a monotherapy
Subjects who were not candidates to receive one or more of the above
treatments (ie, contraindicated) are eligible; the reason for not receiving
treatment must be clearly documented in the case report form
\. Subjects must have measurable disease
\. Subject must be willing to provide fresh bone marrow biopsy samples during
Screening (and prior to study treatment, if required)
\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
\. Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function

Exclusion Criteria

Subjects with known active or history of CNS involvement by malignancy
Subjects with solitary plasmacytoma; active or history of plasma cell leukemia (PCL); Waldenstrom's macroglobulinemia; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasmaproliferative disorder, Skin changes (POEMS) syndrome; or symptomatic amyloidosis
History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected
Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R])
Prior CAR T-cell or other genetically-modified T-cell therapy
Prior treatment with a BCMA-targeted agent
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Untreated or active infection at time of initial screening, at the time of leukapheresis, within 72 hrs before lymphodepletion, or 5 days before JWCAR129 infusion
History of any of the following cardiovascular conditions within 6 months of initial screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease
History of severe immediate hypersensitivity reaction to any of the protocol-mandated or recommended agents used in this study
Allogeneic hematopoietic stem cell transplantation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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