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New treatment option for Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Official title A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05924750
What this study is testing
What is BL-M11D1?
BL-M11D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory acute myeloid leukemia (r/r aml).
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
- Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of BL-M11D1. Ib: Further observe the safety and tolerability of BL-M11D1 at the recommended dose in phase Ia to determine the recommended dose in phase II clinical study (RP2D).
- 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
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Histologically and/or cytologically confirmed CD33-positive relapsed/refractory acute myeloid leukemia (AML);
You likely can't join if
- Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia.
- Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or...
- History of severe heart disease, such as left ventricular ejection fraction \< 50%, history of symptomatic congestive heart failure (CHF) ≥ grade 2...
- Prolonged QT interval (QTc \> 450 msec in men or QTc \> 470 msec in women), complete left bundle branch block, and III degree atrioventricular block.
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid...
- Other malignancies diagnosed within 5 years before the first dose, except for radical basal cell carcinoma, squamous cell carcinoma, and/or radical...
See the full eligibility criteria
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Histologically and/or cytologically confirmed CD33-positive relapsed/refractory acute myeloid leukemia (AML);
- Morphological assessment showing ≥5% blasts in the bone marrow;
- ECOG performance status score ≤2;
- Peripheral blood white blood cell count ≤25×10\^9/L before the first dose;
- Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- Organ function levels meet the requirements within 7 days before the first dose;
- For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All...
- Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia.
- Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors)...
- History of severe heart disease, such as left ventricular ejection fraction \< 50%, history of symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ grade 2 heart...
- Prolonged QT interval (QTc \> 450 msec in men or QTc \> 470 msec in women), complete left bundle branch block, and III degree atrioventricular block.
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases and Hashimoto's thyroiditis...
- Other malignancies diagnosed within 5 years before the first dose, except for radical basal cell carcinoma, squamous cell carcinoma, and/or radical resection carcinoma in situ.
- Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg).
- Patients with pulmonary disease grade ≥3 defined by CTCAE v5.0, current or previous interstitial lung disease (ILD).
- Patients with central nervous system involvement.
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M11D1.
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- Human immunodeficiency virus (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive; HBcAb positive and HBV-DNA copy number \> lower detection limit) or active hepatitis C virus...
- Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
- Presence of pleural, abdominal, pelvic or pericardial effusion with clinical symptoms or requiring repeated drainage.
- Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose).
- Pregnant or lactating women.
- Other conditions for participation in the trial were not considered appropriate by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Haerbin, Heilongjiang, China
- Shenyang, Liaoning, China
- Jinan, Shangdong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, 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 Hefei, Anhui, China; Beijing, Beijing Municipality, China; Haerbin, Heilongjiang, China; Shenyang, Liaoning, China; Jinan, Shangdong, China; Shanghai, Shanghai Municipality, China and 2 more location(s). 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.