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Experimental drug BL-M08D1 takes on recurrent lymphoid cancers

NCT ID NCT06718634

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing an experimental drug called BL-M08D1 in 22 adults with relapsed or refractory lymphoid malignancies (cancers of the lymph system that have come back or not responded to treatment). The drug is given by IV every 3 weeks. The main goals are to check safety, find the right dose, and get a first look at whether it might help shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BL-M08D1 (an experimental drug given by IV infusion every 3 weeks)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat lymphoid cancers that have come back or not responded to standard therapy.
What could go wrong
This is a very early Phase 1 trial with only 22 participants, so the main goal is safety and dosing, not proof of effectiveness. The drug may cause side effects or fail to shrink tumors.
Why investors are watching

Sichuan Baili Pharmaceutical is testing BL-M08D1, an experimental drug for people with blood cancers that have returned or stopped responding to treatment. This early-stage trial checks whether the drug is safe and tolerable in 22 patients, and a clear result matters because the company is small and this program could define its pipeline.

If it works: If BL-M08D1 shows acceptable safety and signs of disease control, the company could advance the drug to later-stage testing and strengthen its position as a developer of cancer therapies.

If it fails: Phase 1 trials often fail because the drug proves too toxic or shows little benefit, and a poor result could set the program back or end it. Delays in enrollment or data readouts could also hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Gender is not limited; 3. Age: ≥18 years old and ≤75 years old; 4. Expected survival time ≥3 months; 5. Recurrent or refractory lymphoid malignancies confirmed by histopathology and/or cytology that are incurable or for which no standard treatment is currently available; 6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years; 7. ECOG≤2; 8. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 10. Organ function level must meet the requirements; 11. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN; 12. Urinary protein ≤2+ or ≤1000mg/24h; 13. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment; 14. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Palliative radiotherapy or traditional Chinese medicine with anti-tumor indications within 2 weeks before the first dose; 2. History of severe heart disease; 3. QT prolongation, complete left bundle branch block, III degree atrioventricular block; 4. Active autoimmune and inflammatory diseases; 5. Other malignant tumors diagnosed within 5 years before the first dose; 6. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg); 7. Patients with poor glycemic control or with diabetic gangrene; 8. A history of ILD requiring steroid therapy or current ILD or grade ≥2 radiation pneumonitis; 9. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 10. Patients with central nervous system involvement; 11. Had a history of or central nervous system disease; 12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any component of BL-M08D1 excipients; 13. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection; 15. Active infection requiring systemic therapy within 4 weeks before the first dose of study drug; 16. Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug; 17. Received another trial drug 4 weeks or 5 half-lives before the first dose; 18. Pregnant or lactating women; 19. Other conditions for participation in the trial were not considered appropriate by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, China