Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    62
  • sponsor
    Carsgen Therapeutics, Ltd.
Updated on 26 January 2021
fludarabine
measurable disease
maintenance therapy
autograft
line of therapy
proteasome inhibitor
refractory multiple myeloma
bcma

Summary

This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT053 CAR-BCMA T in patients with relapsed and/or refractory multiple myeloma.

Description

The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to Detailed Description: verify the efficacy and safety of the dose proposed.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment CAR-BCMA T cells
Clinical Study IdentifierNCT03975907
SponsorCarsgen Therapeutics, Ltd.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study
Age 18 years and 75 years, male or female
The patients have received at least 3 prior regimen for MM, (Induction therapy followed by autologous transplantation[ASCT] and maintenance therapy represents one line of therapy, those who have not been treated with ASCT should have documented rationale); For each line of therapy, the patient should have received at least one standard treatment cycle (2016 IMWG) unless the best response to the treatment line is documented as progressive diseases (PD)
The patients should have received treatment with at least one proteasome inhibitor AND one immunomodulatory drug, and have ever been relapsed or deteriorated after treatment with at least one regimen consisting of above-mentioned medications (combination or single use)
Patient should be relapsed within 12 months after the last line of therapy, or not achieved at least minimal response (MR) or disease progressed within 60 days after last line of therapy (IMWG criteria 2016), with documented evidence
The patients should have measurable disease based on at least one of the following parameters
Serum M-protein 10 g/L
Urine M-protein 200 mg/24 hrs
For those whose Serum or Urine M- protein dose not meed the measurable criteria but the light chain type, serum free light chain (FLC): involved FLC level 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
Estimated life expectancy > 12 weeks
ECOG performance score 0-1
Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis
Patients should maintain adequate organ function
Women of childbearing age must undergo a serum pregnancy test with negative results before screening and lymphodepletion preconditioning with fludarabine and cyclophosphamide, and are willing to use effective and reliable method of contraception for at least 1 year after T cell infusion
Men who actively have intercourse with child-bearing potential women must be willing to use effective and reliable method of contraception for at least 1 year after T cell infusion

Exclusion Criteria

Pregnant or lactating women
P2. Positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema Pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), HBV e antigen (HBeAg), HBV e antibody, hepatitis B core antibody, HBV DNA
Patients with any uncontrolled active infection including but not limited to active tuberculosis
Patients with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) 1, excluding hair loss, neuropathy and other events that the treating physician can determine to be tolerable
Patients who have ever had any CAR T cell therapy
Patients who have ever had anti-BCMA therapy
Patients have received allogeneic stem cell transplantation for treating multiple myeloma
Patients have received autologous stem cell transplantation less than 12 weeks before leukapheresis
Patients have received any anti-cancer treatment within 14 days before leukapheresis including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulatory agents, targeted therapies, epigenetic therapy or experimental drug therapy. If the field of radiation covers 5% of the bone marrow, the subjects are eligible to participate in the study regardless of the radiotherapy end date
Patients have received 5 mg prednisone daily or other equivalent dose of steroids within 14 days before leukapheresis or lymphodepletion
Patients have plasma cell leukemia, Waldenstrm macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or AL amyloidosis
Patients have been administered live attenuated vaccine 4 weeks before leukapheresis or lymphodepletion
Patients allergic to component of study treatment
Patients have any of the condition as following within 6 months of ICF sign-off: New York Heart Association (NYHA) stage III or IV congestive heart failure, angina pectoris, myocardial infarction, coronary artery bypass graft, stroke (excluding lacunar stroke), history of clinically significant arrhythmia including but not limited to ventricular arrhythmia, significant QT interval prolongation, uncontrolled blood pressure as defined as systolic > 160 mmHg, diastolic > 100 mmHg, uncontrolled diabetes mellitus, pulmonary thrombolism, other conditions that investigators believe that participating in this clinical trial may endanger the health of the patients
Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy
patients are oxygen dependent as defined by the blood oxygen saturation (finger oxygen detection method) can be maintained > 95% only by oxygen inhalation before leukapheresis
Patients with second malignancies in addition to MM are not eligible if the second malignancy has required treatment within the past 5 years or is not in complete remission. There are two exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal cell skin carcinoma
Patients have central nervous system (CNS) metastases or CNS involvement (including cranial neuropathies or mass lesions and leptomeningeal disease). Patients with history of spinal cord compression from MM are eligible provided spinal cord compression has been treated with surgery or radiation at least 28 days prior to study entry
Patients are unable or unwilling to comply with the requirements of clinical trial
Patients have received major surgery 2 weeks prior to leukapheresis or 4 weeks prior to lymphodepletion and after the study treatment (excluding cataract and other local anesthesia)
Patients are relatives to investigator or his/her staff, or those who may have an interest in the investigator and/or his/her staff
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