the Safety and Efficacy of SENL103 Autologous T Cell Injection

Last updated: September 27, 2023
Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Red Blood Cell Disorders

Cancer/tumors

Treatment

SENL103

Clinical Study ID

NCT06067581
SENL103 CAR-T
  • Ages 18-75
  • All Genders

Study Summary

To observe the safety and efficacy of SENL103 cells in the treatment of patients with recurrent or refractory plasma cell blood tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age 18-75 years old, gender is not limited;
  2. Understand and know about this study and sign the informed consent voluntarily;
  3. Patients diagnosed with recurrent/refractory plasma cell blood tumors must: a) havereceived at least 3 kinds of anti-plasma cell blood tumor therapy, including at leastone proteasome inhibitor and one immunomodulator; b) documented progression within 12months of treatment of the most recent antiplasmacytic blood tumor, or efficacyassessed as SD or PD within 60 days of treatment of the most recent antiplasmacyticblood tumor;
  4. meet one of the following detection indicators: a) serum M protein ≥5g/L; b) Urine Mprotein ≥200mg/24h; c) Affected serum free light chain ≥100mg/L and abnormal serumfree light chain ratio; d) Bone marrow plasma cell ratio ≥10%;
  5. ECOG score is 0-2 points; 6, liver and kidney function, cardiopulmonary function meetthe following requirements: a) blood creatinine ≤150umol/L, or creatinine clearance (estimated by Cockcroft Gaultra formula) ≥40ml/min (if the kidney function injurycaused by rapid progression of the primary disease, the inclusion criteria can beappropriately relaxed, and the decision is made by the investigator); b) Totalbilirubin ≤2×ULN; ALT≤3 x ULN, AST≤3 x ULN; c) Echocardiography showed normaldiastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no seriousarrhythmias; d) The subjects had no active pulmonary infection, and the blood oxygensaturation of indoor air was > 90%;
  6. The subjects had no contraindications for peripheral blood monopexy, hemoglobin ≥60g/L,platelets ≥50×10^9/L, neutrophils ≥1×10^9/L; 8. Expected survival >12 weeks; 9. The urinepregnancy test of female subjects of childbearing age should be negative and not in thelactation period; Women or men of reproductive age were required to use effectivecontraception throughout the study.

Exclusion

Exclusion Criteria:

  1. Have had severe rapid hypersensitivity to any of the drugs to be used in this study;
  2. History of central nervous system (CNS) diseases, such as seizures, paralysis,aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy; Knownactive central nervous system (CNS) involvement or history of modification or clinicalsigns of multiple myeloma meningeal/spinal meningeal involvement;
  3. Accompanied by other uncontrolled malignancies (except adequately treated cervicalcarcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancerafter radical surgery, ductal carcinoma in situ after radical surgery, and thyroidcancer after radical surgery);
  4. The presence of clinically significant cardiovascular disease, such as uncontrolled orsymptomatic arrhythmias, congestive heart failure, or any grade III (moderate) orgrade IV (severe) heart disease (according to the New York Heart Society FunctionalGrading Method NYHA*); Patients with a history of myocardial infarction, angioplastyor stenting, unstable angina pectoris, or other clinically significant heart diseasewithin 12 months prior to enrollment;
  5. Previous patients with craniocerebral trauma, cerebrovascular accident, more seriouscerebral ischemia or cerebral hemorrhage diseases;
  6. The investigator determines that there are serious complications or diseases thatincrease the risk of the subject or affect the study, including but not limited to,for example, cirrhosis of the liver, recent major trauma, etc.;
  7. Allogeneic hematopoietic stem cell transplantation performed within six months priorto screening, or hematopoietic stem cell transplantation performed during thescreening period for any immunosuppressive treatment due to graft-versus-host disease;
  8. Patients with autoimmune diseases, immune deficiencies or other immunosuppressants (other than low-dose glucocorticoids) are required;
  9. Any uncontrolled active infection, including but not limited to active tuberculosis;Suspected uncontrollable fungal, bacterial, viral, or other infection prior toenrollment;
  10. Received attenuated live vaccine within 4 weeks before anapheresis;
  11. Subjects with active hepatitis (hepatitis B virus DNA >100IU/ml or hepatitis C virusRNA [HCVRNA] positive), syphilis, and other acquired and congenital immunodeficiencydiseases, including but not limited to HIV-infected persons; People infected with CMVvirus (CMV DNA test positive);
  12. The subject has a history of alcoholism, drug abuse or mental illness;
  13. Failure to follow the following treatment requirements needs to be excluded: A) Hormones: Subjects shall not receive more than 5mg of prednisone or otherequivalent doses of corticosteroids and other immunosuppressive drugs within 72 hoursprior to PBMC cell collection; B) Prior anti-tumor therapy (prior to PBMC monotherapy) : targeted therapy, epigenetic therapy or investigational drug therapy, or use ofinvasive investigational medical devices must have ended 14 days prior to PBMC cellcollection or at least 5 half-lives (whichever is longer); Treatment of multiplemyeloma with monoclonal antibodies ended at least 21 days before cell collection;Cytotoxic therapy should be completed at least 14 days before cell collection.Protease inhibitor treatment should end at least 14 days before cell collection. Theimmunomodulator should end at least 7 days before cell collection; C) Radiotherapy:must be completed no later than 4 weeks before PBMC cell collection, but if theradiotherapy field covered ≤ 5% of bone marrow reserve, participants were eligible toparticipate regardless of the radiotherapy end date; D) Anti-T cell antibody drugs (such as alenzumab) must be terminated 8 weeks before cell collection;
  14. Researchers consider it inappropriate to participate in this experiment.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: SENL103
Phase: 1
Study Start date:
August 21, 2023
Estimated Completion Date:
August 31, 2025

Study Description

Primary endpoint To observe the number and incidence of adverse events after intravenous infusion of SENL103. To evaluate possible adverse reactions recorded within 1 month after SENL103 infusion, including the number, incidence and severity of symptoms such as cytokine release syndrome and neurotoxic reactions; Secondary endpoints

  1. Efficacy indicators: The efficacy after cell retransfusion was observed by strict complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD), and progression-free survival (PFS rate);

  2. PK index: the highest concentration of SENL103 cells amplified in peripheral blood (Cmax, measured by flow cytometry and qPCR), the time to reach the highest concentration (Tmax) and the duration of cell survival in the patient;

  3. PD index: proportion of peripheral blood plasma cells, concentration of free BCMA and cytokine release at each time point;

  4. Quality of life assessment: the changes of subjects' quality of life before and after treatment were observed.

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

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