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New treatment option for Relapsed/Refractory Multiple Myeloma(MM)
Official title Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07139509
What this study is testing
What is allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells?
allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory multiple myeloma(mm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to learn if allogeneic cord blood-derived CAR-T cell drug works to treat Multiple Myeloma (MM) including Bone-related extramedullary (EMB) disease and extramedullary extraosseous disease(EME) in adults. It will also learn about the safety of the allogeneic cord blood-derived CAR-T cell drug.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1.Aged 18 to 75 years (inclusive of boundary values), with no limitation on gender;
- 2.Diagnosed with multiple myeloma in accordance with the "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (2022 Revision)" :
- Bone marrow monoclonal plasma cell percentage ≥10% and/or histopathological evidence of plasmacytoma; and presence of at least one of the following...
- S: Bone marrow monoclonal plasma cell percentage ≥60%;
- Li: Ratio of involved to uninvolved serum free light chain ≥100 (with the involved light chain value being at least ≥100 mg/L);
You likely can't join if
- 1.Participants meeting any of the following criteria are not eligible for enrollment in this study:
- 2.Lactating women;
- 3.Unwillingness to undergo follow-up for 15 years;
- 4.Poor compliance with the study procedures;
- 5.Individuals under legal guardianship or conservatorship;
- 6.with a history of ≥Grade 4 CRS or neurotoxicity in previous CAR-T therapy ;
See the full eligibility criteria
Who can join
- 1.Aged 18 to 75 years (inclusive of boundary values), with no limitation on gender;
- 2.Diagnosed with multiple myeloma in accordance with the "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (2022 Revision)" :
- Bone marrow monoclonal plasma cell percentage ≥10% and/or histopathological evidence of plasmacytoma; and presence of at least one of the following SLiM CRAB features: SLiM refers to:
- S: Bone marrow monoclonal plasma cell percentage ≥60%;
- Li: Ratio of involved to uninvolved serum free light chain ≥100 (with the involved light chain value being at least ≥100 mg/L);
- M: MRI detection of \>1 focal bone lesion larger than 5 mm. CRAB refers to:
- C: Corrected serum calcium \>2.75 mmol/L [Corrected serum calcium (mmol/L) = serum total calcium (mmol/L) - 0.025×serum albumin concentration (g/L) + 1.0 (mmol/L), or corrected serum calcium (mg/dl) = serum total...
- R: Renal insufficiency (creatinine clearance \ 177 μmol/L);
- A: Anemia (hemoglobin \< lower limit of normal by 20 g/L or \<100 g/L);
- B: Lytic bone lesions, demonstrated by radiographic imaging (X-ray, CT, MRI, or PET-CT) showing one or more lytic bone lesions.
- Definition of relapsed/refractory multiple myeloma:
- Must have received at least three therapeutic regimens (The induction and maintenance therapies associated with hematopoietic stem cell transplantation, whether one or both were performed, are considered as one...
- Must have been treated with a proteasome inhibitor, an immunomodulatory agent, or an anti-CD38 antibody;
- Must be refractory to the last therapeutic regimen [refractory is defined as disease progression documented during or within 60 days after completion of the last anti-multiple myeloma therapeutic regimen (based on the...
- 3.Presence of at least one measurable lesion, meeting at least one of the following criteria:
- Serum M protein ≥0.5 g/dL;
- Urine M protein ≥200 mg/24 hours;
- Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (100 mg/L), provided that the serum FLC ratio is abnormal;
- Biopsy-proven evaluable plasmacytoma;
- Bone marrow plasma cells constituting \>30% of total bone marrow cells;
- 4.Negative for Donor Specific Antibody (DSA);
- 5.The most recent assessment during the screening period indicates sufficient organ function, including renal and hepatic function, defined as:
- Creatinine clearance rate ≥60 mL/min (calculated according to the Cockcroft-Gault formula);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN (upper limit of normal);
- Total bilirubin ≤1.5×ULN (for participants with a history of Gilbert's syndrome, total bilirubin ≤2.5×ULN).
- 6.Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment. In this study, women of childbearing potential, their male partners with reproductive potential, and their...
- 7.Written informed consent obtained before the initiation of any study-specific procedures.
What rules you out
- 1.Participants meeting any of the following criteria are not eligible for enrollment in this study:
- 2.Lactating women;
- 3.Unwillingness to undergo follow-up for 15 years;
- 4.Poor compliance with the study procedures;
- 5.Individuals under legal guardianship or conservatorship;
- 6.with a history of ≥Grade 4 CRS or neurotoxicity in previous CAR-T therapy ;
- 7.Within 5 half-lives of prior anti-MM therapies (including approved therapies and other investigational drugs) before enrollment;
- 8.Disease progression after debulking therapy;
- 9.Active central nervous system (CNS) abnormalities or history of irreversible severe CNS toxicity from prior MM treatment leading to CNS organic lesions or CNS dysfunction;
- 10.Radioimmunotherapy or radiotherapy within 8 weeks before enrollment;
- 11.Hematopoietic stem cell transplantation (HSCT) within 3 months before screening, donor lymphocyte infusion within 6 weeks before screening; patients who have undergone autologous stem cell transplantation within 100...
- 12.Active acute or chronic graft-versus-host disease (GvHD) requiring systemic therapy within 4 weeks before UC503 cells infusion;
- 13.Patients with autoimmune diseases who are unable to discontinue systemic immunosuppressive therapy;
- 14.Patients currently receiving or having received high-dose (total dose of 60 mg dexamethasone or equivalent other corticosteroid) systemic corticosteroid therapy within 4 weeks before lymphodepletion;
- 15.Known hypersensitivity to UCAR-T or any of its components;
- 16.Any known uncontrolled cardiovascular disease within 6 months before enrollment, or any of the following conditions: ≥Grade 2 ventricular or atrial arrhythmias, ≥Grade 2 bradycardia, myocardial infarction...
- 17.Any known uncontrolled pulmonary disease within 6 months before enrollment, or any of the following conditions: pulmonary embolism, chronic obstructive pulmonary disease, history of idiopathic pulmonary fibrosis...
- 18.History of hypertensive crisis or hypertensive encephalopathy within 3 months before screening;
- 19.At enrollment, active bacterial, fungal, protozoal, or viral infections that are not effectively controlled despite adequate treatment, and positive blood cultures within 7 days before enrollment;
- 20.Undergone any major surgery within 3 months before screening;
- 21.Received any live-attenuated vaccine within 4 weeks before screening;
- 22.Any abnormal findings, medical conditions, or laboratory test results during the screening period that the investigator deems may jeopardize patient safety;
- 23.Any planned medical or surgical treatment that may interfere with the normal conduct of the study;
- 24.Presence of another malignancy within 2 years before screening (excluding in situ basal or squamous cervical cancer or cutaneous basal cell carcinoma);
- 25.Patient's psychiatric condition that prevents understanding of the nature, scope, and potential consequences of the study, and/or unwillingness to cooperate;
- 26.At enrollment, positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; positive for hepatitis C...
- 27.Contraindications to any drugs that may be used, including lymphodepleting agents such as fludarabine and cyclophosphamide, or agents maybe used for managing adverse events such as tocilizumab.
The study team makes the final eligibility decision.
Where it's taking place
- Xi’an, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi’an, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.