Status and phase
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About
The purpose of this study is to see if the quality of T cells used to create ide-cel (bb2121) affects how ide-cel prevents cancer from coming back in people with relapsed or refractory multiple myeloma (MM), and who have had a hematopoietic cell transplant.
Enrollment
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Volunteers
Inclusion criteria
Cohort 1:
Patient with myeloma who has received at least four prior lines of treatment having been exposed to an IMID, PI, and a CD38 monoclonal antibody and had measurable disease prior to salvage high dose melphalan autoHCT done within the prior 2 - 6 months. (Salvage melphalan/AutoHCT can count as the 4th line of treatment).
Measurable disease is defined by any of the following:
Cohort 2:
Patients with pathologically confirmed MM who have received at least 4 prior lines of treatment having been exposed to an IMID, PI, and a CD38 monoclonal antibody and have undergone an allo HCT for RRMM at any time in their history and have at least minimal residual disease by flow or NGS in the bone marrow at least 3 months after allo HCT.
Prior to Leukapheresis:
Hepatic Function:
Female patients of childbearing potential (FCBP) must:
Male patients must:
Prior to LD Chemotherapy
Hepatic Function:
CrCl ≥ 45 mL/min, measured or estimated by Cockcroft-Gault equation
INR or PTT ≤ 1.5 x ULN
No history of ≥ Grade 2 hemorrhage within 30 days
No presence of active/uncontrolled infection requiring systemic therapy. Prophylactic antimicrobials are allowed.
No intercurrent illness or toxicity that would place the subject at undue risk of proceeding to LD chemotherapy
Must not be taking therapeutic doses of corticosteroids (defined as greater than 10 mg/day prednisone or equivalent) within 72 hours prior to LD chemotherapy. Physiologic replacement, topical, intranasal and inhaled steroids are permitted. Patients on calcineurin inhibitors (cyclosporine or tacrolimus) should have levels considered undetectable per institutional criteria
No active urinary outflow obstruction
Availability of manufactured cells
Patients not meeting these criteria may still be eligible to initiate LD chemotherapy with the approval of the Protocol PI (Principal Investigator).
Prior to Ide-Cel or Cilta-Cel infusion
Subjects who meet at least one of the following criteria on the day of scheduled CAR T cell infusion should have its administration delayed:
Exclusion criteria
Receiving any of the following less than 14 days prior to enrollment:
Prior organ transplant requiring systemic immunosuppressive therapy
History of ≥ Grade 2 hemorrhage within 30 days of enrollment
Patient requiring ongoing treatment with chronic, therapeutic dosing of anticoagulants (e.g., Warfarin, low molecular weight heparin, Factor Xa inhibitors) can be enrolled with approval of the PI.
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Having concurrent Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
History of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or hemodynamically significant ventricular arrhythmia within the previous 6 months prior to enrollment
Active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible. Patients with a history of acute or chronic GVHD are potentially eligible if on minimal immunosuppressants as defined previously.
Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or C, or acute hepatitis A. If any history of exposure to hepatitis B or C, then DNA PCR should be negative. If hepatitis B core Ab positive with negative DNA PCR, patients should be on prophylaxis while on study.
Prior malignancies except resected basal cell carcinoma or treated carcinoma in situ. Cancer treated with curative intent less than 5 years prior to enrollment will not be allowed unless approved by the PI. Cancer treated with curative intent greater than 5 years prior to enrollment is allowed.
Female patients who are breastfeeding or who intend to become pregnant during participation in the study.
Known allergy or hypersensitivity to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Serious medical of psychiatric illness likely to interfere with participation on this clinical study
Uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
Unwilling or unable to provide informed consent
Unable or unwilling to return to the center for treatment and follow up
No systemic anti-myeloma therapy is allowed within 7 days prior to leukapheresis. Steroids are allowed, but should be tapered off by 72 hours prior to leukapheresis.
Steroids are allowed between leukapheresis and LD chemotherapy, but should be tapered off by 72 hours prior to lymphodepletion.
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups
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Central trial contact
Gunjan Shah, MD; Sergio Giralt, MD
Data sourced from clinicaltrials.gov
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