Clinical trial for Multiple Myeloma
Official title Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma
ClinicalTrials.gov ID: NCT05976555
What this study is testing
What is BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)?
BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
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
- This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and efficacy of interleukin-7(IL-7) / interleukin-15 (IL-15) manufactured CAR T cells in adult patients with relapsed and/or refractory myeloma that have failed prior therapies.
- 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 80
You may be able to join if
- Patients must be aged ≥18 years to 80 years old.
- Patients must have received three prior lines of therapies, including proteasome inhibitor, immunomodulator and a cluster of differentiation (CD) 38...
- International Myeloma Working Group (IMWG) criteria defines refractory disease as disease progression on or within 60 days of receiving therapy.
- Patients must have measurable disease, including at least one or more of the following criteria:
- Serum M-protein ≥0.5 g/dl;
You likely can't join if
- Positive beta- Human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per the Schedule of Events table.
- Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \>20 mg of prednisone or...
- Presence of ≥ Grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying...
- Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5...
- Refusal to participate in the long-term follow-up protocol.
See the full eligibility criteria
Who can join
- Patients must be aged ≥18 years to 80 years old.
- Patients must have received three prior lines of therapies, including proteasome inhibitor, immunomodulator and a cluster of differentiation (CD) 38 monoclonal antibody:
- International Myeloma Working Group (IMWG) criteria defines refractory disease as disease progression on or within 60 days of receiving therapy.
- Patients must have measurable disease, including at least one or more of the following criteria:
- Serum M-protein ≥0.5 g/dl;
- Urine M-protein ≥200 mg/24 hrs;
- Involved serum light chain ≥100 mg/L with abnormal light chain ratio;
- Absolute CD 3 count ≥50 mm\^3.
- Karnofsky performance score ≥70.
- Adequate hepatic function, defined as:
- aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase \<3x upper limit of normal (ULN);
- Serum bilirubin \<2.0 mg/dL except for patients with Gilbert's syndrome, who must have serum bilirubin of \<3 mg/dL.
- Absolute neutrophil count (ANC) ≥1,000 with no Granulocyte colony-stimulating factor (G-CSF) within 72 hours or pegylated G-CSF within 10 days.
- Platelets ≥50,000/µL with no transfusion within 72 hours of eligibility testing.
- Adequate renal function, defined as creatinine clearance ≥50 mL/min calculated using the Cockroft-Gault formula.
- Able to provide written informed consent.
- Agree to practice birth control during the study.
- Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition (MUGA)) and...
- Expected survival \>12 weeks.
- Negative urine or serum pregnancy test in females of childbearing potential at study entry.
- Meet criteria for regarding fertility and contraception detailed below.
- No contraindication to central line access. Phase I Dose-Expansion Cohort A: BCMA Naïve The for dose-expansion Cohort A are the same as that listed above but are limited to BCMA naïve patients. Phase I Dose-Expansion...
What rules you out
- Positive beta- Human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per the Schedule of Events table.
- Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \>20 mg of prednisone or equivalent daily.
- Presence of ≥ Grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.
- Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to...
- Refusal to participate in the long-term follow-up protocol.
- Patients with active central nervous system (CNS) involvement by malignancy on MRI or by lumbar puncture. a. Patients with prior CNS disease that has been effectively treated will be eligible providing last treatment...
- Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \<6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are...
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, and AL amyloidosis.
- Prior treatment with gene therapy or any gene modified cellular therapy (only permitted in cohort B for the dose expansion phase).
- Prior BCMA-directed therapy (only permitted in cohort B for the dose expansion phase).
- Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of apheresis or after apheresis.
- Corticosteroids are allowable up until 7 days prior to apheresis and after apheresis for disease control up until the day prior to cell infusion (Day -1).
- Radiation is allowed to a single symptomatic site.
- Patients post solid organ transplant who develop high grade lymphomas or leukemias.
- Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
- Active bacterial, viral, or fungal infection requiring systemic treatment.
- Patients who have received major surgery 1 week prior to leukapheresis and 3 weeks prior to lymphodepletion.
- Active malignancy that required therapy in the last 2 years except successfully treated non metastatic basal or squamous cell carcinoma, or prostate carcinoma that does not require therapy. Other similar conditions may...
- Condoms (male or female) with or without a spermicidal agent.
- Diaphragm or cervical cap with spermicide.
- Intrauterine device (IUD).
- Hormonal-based contraception. people who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation...
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. 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.