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New treatment option for Multiple Myeloma
Official title A Study of BL-M24D1 in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
ClinicalTrials.gov ID: NCT07255898
What this study is testing
What is BL-M24D1?
BL-M24D1 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 study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-M24D1 in patients with relapsed or refractory multiple myeloma and other hematologic malignancies.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Gender is not restricted;
- Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
- Expected survival time ≥3 months;
- Histologically and/or cytologically confirmed multiple myeloma or other hematologic malignancies that have failed standard treatment or for which no...
You likely can't join if
- people with central nervous system involvement, etc.;
- Use of chemotherapy, biologics, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;
- History of severe heart disease;
- QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of other malignancies within 5 years prior to the first dose;
See the full eligibility criteria
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Gender is not restricted;
- Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
- Expected survival time ≥3 months;
- Histologically and/or cytologically confirmed multiple myeloma or other hematologic malignancies that have failed standard treatment or for which no standard treatment currently exists;
- Must have measurable indicators as defined by the protocol;
- Physical condition score ECOG 0 or 1;
- Toxicity from previous antitumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Organ function levels must meet the requirements;
- Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
- For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, the serum pregnancy test must be negative, and they must not be breastfeeding; all...
- people with central nervous system involvement, etc.;
- Use of chemotherapy, biologics, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;
- History of severe heart disease;
- QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of other malignancies within 5 years prior to the first dose;
- Hypertension poorly controlled by two antihypertensive medications;
- Patients with poorly controlled blood glucose;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
- Lung diseases defined as ≥ Grade 3 according to CTCAE v5.0; history of interstitial lung disease requiring hormone treatment, etc.;
- Patients with peripheral neuropathy ≥ Grade 3 or persistent ≥ Grade 2 peripheral neuropathy with pain;
- Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1;
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- Human immunodeficiency virus antibody positivity, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration, etc.;
- Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration;
- people with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first study drug administration;
- Participation in another clinical trial within 4 weeks prior to the first dose;
- Pregnant or breastfeeding women;
- Patients who received live vaccines within 30 days prior to the first dose;
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, 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.