BridgeMD
New treatment option for Multiple Myeloma, Refractory to Standard Treatment
Official title Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
ClinicalTrials.gov ID: NCT06971380
What this study is testing
What is HBI0101 CART?
HBI0101 CART is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma, refractory to standard treatment.
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
- A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to evaluate the efficacy and safety of HBI0101 CART.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years of age at the time of signing informed consent.
- Voluntarily signed informed consent form.
- Diagnosis of multiple myeloma and/or light-chain amyloidosis with relapsed or refractory disease, with measurable disease at screening visit
- Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
You likely can't join if
- Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.
- Known bulky central nervous system disease.
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN)...
- Inadequate renal function defined by serum creatinine clearance/estimated clearance of \<20(ml/min).
- International ratio (INR) or partial thromboplastin time (PTT) \> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event...
- Inadequate bone marrow function defined by absolute neutrophil count (ANC) \< 1000 cells/mm\^3, platelet count \< 30,000 mm\^3, or hemoglobin \< 8...
See the full eligibility criteria
- ≥18 years of age at the time of signing informed consent.
- Voluntarily signed informed consent form.
- Diagnosis of multiple myeloma and/or light-chain amyloidosis with relapsed or refractory disease, with measurable disease at screening visit
- Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy or anti-CD38 antibody, or functionally high-risk...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must...
- Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy.
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
- people with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation must have no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least...
- Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.
- Known bulky central nervous system disease.
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN) and direct bilirubin \> 4x ULN.
- Inadequate renal function defined by serum creatinine clearance/estimated clearance of \<20(ml/min).
- International ratio (INR) or partial thromboplastin time (PTT) \> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).
- Inadequate bone marrow function defined by absolute neutrophil count (ANC) \< 1000 cells/mm\^3, platelet count \< 30,000 mm\^3, or hemoglobin \< 8 g/dL. people with absolute lymphocyte count \< 300 cells/mm\^3 may be...
- Echocardiogram with left ventricular ejection fraction \< 40%.
- Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg/m\^2/d hydrocortisone or equivalent)
- Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease...
- Known human immunodeficiency virus (HIV) positive status.
- Active Hepatitis B or Hepatitis C active infection.
- Active CMV infection.
- Known history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.
- Chronic atrial fibrillation with uncontrolled heart rate.
- Second primary malignancies that has required therapy in the last 2 years or is not in complete remission.
- people who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:
- Have been on a stable dose of anticoagulation for \< 1 month (except for acute line insertion induced thrombosis.)
- Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days
- Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).
- Pregnant or lactating women.
- Participation in another treatment clinical trial within 30 days prior to screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. 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.