BCMA/CD3 BiTE for RRAL or NDAL Amyloidosis With Insufficient Depth of Hematologic Response After … (NCT06769555) | Clinical Trial Compass
WithdrawnNot Applicable
BCMA/CD3 BiTE for RRAL or NDAL Amyloidosis With Insufficient Depth of Hematologic Response After Induction Therapy
Stopped: The study protocol was withdrawn because, after modifications, the study transitioned from an Investigator-Initiated Trial (IIT) to an Investigational New Drug (IND) clinical trial. This change necessitated a multi-center approach.
0Started 2025-01-01
Plain-language summary
The goal of this clinical trial is to evaluate the effectiveness and safety of CM-336, which is a BCMA/CD3 BiTE, in patients with relapsed/refractory AL amyloidosis or newly diagnosed AL amyloidosis with insufficient depth of hematologic response after induction therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients aged 18 years or older
* Biopsy-proven diagnosis of AL amyloidosis, according to the following standard criteria:
* Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
* If clinical and laboratory parameters are insufficient to establish AL amyloidosis, or in cases of doubt, amyloid typing may be necessary
* Provide informed consent form
* Measurable disease, as defined by serum differential free light-chain concentration (dFLC; defined as the difference between amyloid forming \[involved\] and nonamyloid forming \[uninvolved\] free light-chain \[FLC\]) ≥50 mg/L)
* Received at least one prior line of therapy
* Must have been exposed to CD38 mAb
* Relapsed/refractory AL amyloidosis or newly diagnosed AL amyloidosis with insufficient depth of hematologic response after induction therapy
* Relapsed is defined as documented progressive disease \>60 days after the last dose of prior therapy
* Refractory is defined as the documented absence of a hematologic response or hematologic progression on or within 60 days after the last dose of prior therapy
* Insufficient depth of hematologic response is defined as less than hematological PR by 2 cycles or less than hematologic VGPR by 4 cycles
* Eastern Cooperative Oncology Group performance status ≤3
* Clinical laboratory values:
* Absolute neutrophil count ≥1000/µL
* Platelet count ≥75,000/µL
* Hemoglob…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hematologic response VGPR or better rate after four cycles
Timeframe: Four months
2
Adverse events and serious adverse events
Timeframe: Up to 2 year
Trial details
NCT IDNCT06769555
SponsorInstitute of Hematology & Blood Diseases Hospital, China