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Stopped: The study protocol was withdrawn because, after modifications, the study transitioned from an Investigator-Initiated Trial (IIT) to an Investigational New Drug (IND) clinical trial.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 range18 Years
SexALL
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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…
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