A Phase 1/2, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of DRL-1801 in Patients with Relapsed and Refractory Multiple Myeloma (SWASTH). - SWASTH

Aurigene Oncology Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

阶段: 1 期
状态: 招募中
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Males and females = 18 years of age;
•2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 (See Appendix D). (Note: Patients with ECOG PS of 2 because of Multiple Myeloma and not because of comorbidities can be enrolled).
•3. Acceptable bone marrow and organ function at screening as described below:
•a. ANC = 1000/µL (without WBC growth factor support)
•b. Platelet count = 75,000/µL without transfusion support
•c. Hemoglobin = 9 g/dL (Transfusion is allowed to achieve this Hb)
•d. Total Bilirubin = 1.5 x ULN; (Patients with known Gilbert’s syndrome are allowed with a Total Bilirubin = 2.5 x ULN)
•e. AST (SGOT) = 3 x ULN (= 5 × ULN if known myeloma in the liver)
•f. ALT (SGPT) = 3 x ULN (= 5 × ULN if known myeloma in the liver)
•g. Creatinine Clearance (by Cockcroft Gault formula) ? 30 ml/min
•4. Documented diagnosis of multiple myeloma
•5. Must have received prior treatment for Multiple Myeloma. Note: Both patients with or without hematopoietic stem cell transplant eligibility are allowed.
•6. Patients must have measurable disease as per IMWG criteria (Kumar S et al, 2016), including at least one of the criteria below:
•Serum M-protein greater or equal to 0.5 g/dL
•Urine M-protein greater or equal to 200 mg/24 h
•Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
•7. Willing and able to provide written informed consent
•8. Ability to communicate well with the investigator and to comply with the requirements of the entire study

排除标准

•1.History or presence of clinically relevant central nervous system.
•2.Patients with active or history of plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly,endocrinopa thy, monoclonal protein, and skin changes),or clinically significant amyloidosis.
•3.Patients with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
•4.Anti-cancer therapy, such as chemotherapy, immuno modulatory drug therapy, immunosuppressive therapy including corticosteroids (unless administered to prevent contrast material reactions during radiographic procedures) received within the past 14 days of LD therapy. Low dose chronic use of corticosteroids (equal to and less than 10 mg prednisone per day or equivalent) is allowed.
•5.International ratio (INR) or partial thromboplas tin time (PTT) Greater than1.5x approximately equal to ULN, or history of Grade Greater than2 hemorrhage within 30 days, or patient requires ongoing treatment with chronic, therapeutic dosing of anti-coagulants (e.g., warfarin, low molecular weight heparin, or Factor Xa inhibitors).
•6.Echocardiogram or MUGA scan with left ventricular ejection fraction Greater than 45 percentage.
•7.Presence of an acute or chronic toxicity resulting from prior chemotherapy, with the exception of alopecia, that has not resolved to Grade equal to and less than 1, as determined by NCI CTCAE v 5.0.
•8.Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to cycle 1 Day 1.
•9.Previously exposed to any approved or investigational CAR-T therapy.
•10.Current or previously treated myeloma in the CNS (Central Nervous System) including current or previous myeloma meningitis.
•11.Major surgery Greater than 28 days from the start of treatment(major surgery is defined as a procedure requiring general anesthesia).
•12.Minor surgery Greater than 14 days from the start of treatment (insertion of a vascular access device is not considered either major or minor surgery).
•13.Active autoimmune disease or any medical condi tion requiring the use of systemic immunosuppressi ive medications (Greater than 10 mg/day of prednisone or equivalent). Patients with thyroid dysfunction,on thyr oid replacement therapy are allowed. Intermittent topical,inhaled or intranasal corticosteroids are allowed.
•14.Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy.
•15.Patient with known hypersensitivity to any component of DRL-1801, cyclophosphamide,fludarbine or tocilizumab.
•16.Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period whi ch is resolved adequately according to investigator by Day 0 is allowed.
•17.Receipt of any vaccines against infectious diseases (e.g., influenza) within 28 days of study drug administration.
•18.Positive for Human immunodeficiency virus (HIV) positive or Hepatitis B or Hepatitis C during screening.14.Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy.
•19.Relapse within 6 months of a

研究者

发起方

Aurigene Oncology Limited

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