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AL AmyloidosisNCT06769555

BCMA/CD3 BiTE for RRAL or NDAL Amyloidosis With Insufficient Depth of Hematologic Response After Induction Therapy

A study testing CM-336 BCMA/CD3 bispecific antibody in people with AL Amyloidosis, run by Institute of Hematology & Blood Diseases Hospital, China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AL Amyloidosis
What is being tested?
CM-336 BCMA/CD3 bispecific antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 1 Aug 2028
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • Hemoglobin ≥75g/L
  • Total bilirubin ≤1.5× the upper limit of normal (ULN), except for patients with Gilbert's syndrome (as defined by >80% unconjugated bilirubin and total bilirubin ≤6 mg/dL)
  • Alkaline phosphatase ≤5× ULN
  • Alanine aminotransferase or aspartate aminotransferase ≤3× ULN
  • Calculated creatinine clearance ≥30 mL/min
  • The woman is not breastfeeding, is not pregnant, and agrees not to be pregnant during the study period and for the following 12 months.
  • Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter.

Who cannot join

  • Non-AL amyloidosis, including hereditary amyloidosis
  • Diagnosed with multiple myeloma, according to the International Myeloma Working Group criteria
  • Have been exposed to BCMA-targeted treatment
  • Known intolerance, hypersensitivity, or contraindication to BCMA BiTE cellular products
  • Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy, after excluding AL amyloidosis-related peripheral neuropathy
  • Medically documented cardiac syncope, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically important autonomic disease
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  • Ongoing or active infection, known HIV-positive status, or active hepatitis B or C infection
  • Women who are pregnant or breastfeeding
  • Subjects had major surgery within 2 weeks before randomization (for example, general anesthesia), or have not fully recovered from the surgery, or surgery is arranged during the study period
  • Received live attenuated vaccine within 4 weeks prior to study treatment
  • According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent.
  • Necessary medication or supportive therapy is contraindicated with study treatment.
  • Any diseases or complications that may interfere with the study. Patients are not willing to or cannot comply with study scheme.

About this study

Official title: A Single-arm Multi-center Trial of BCMA/CD3 Bispecific Antibody for Relapsed/Refractory AL Amyloidosis or Newly Diagnosed AL Amyloidosis With Insufficient Depth of Hematologic Response After Induction Therapy

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.

Read the detailed description

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.

Patients received subcutaneous CM-336 80 mg once weekly in 28-d cycles after two step-up priming doses of 3 mg and 20 mg given on day 1 and day 4 of cycle 1. For patients achieve hematological PR or better after 2 cycles, and hematological VGPR or better after 4 cycles, the treatment regimen will change to 160mg once every 2 weeks (Q2W).

Conditions
AL Amyloidosis
Being tested
CM-336 BCMA/CD3 bispecific antibody
Keywords
AL Amyloidosis, BCMA/CD3 BiTE, CM-336
Medical subject headings
Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM-336 BCMA/CD3 bispecific antibodyDrug

    Patients received subcutaneous CM-336 80 mg once weekly in 28-d cycles after two step-up priming doses of 3 mg and 20 mg given on day 1 and day 4 of cycle 1. For patients achieve hematological PR or better after 2 cycles, and hematological VGPR or better after 4 cycles, the treatment regimen will change to 160mg once every 2 weeks (Q2W).

Study groups in NCT06769555
Study groupRoleWhat they receive
BCMA/CD3 BiTEExperimentalNot described
Receives: Drug: CM-336 BCMA/CD3 bispecific antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematologic response VGPR or better rate after four cycles

    Hematologic response VGPR or better rate based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as evaluated by an Adjudication Committee (AC)

    Measured: Four months

  2. Adverse events and serious adverse events

    Adverse events (AEs), serious adverse events (SAEs), according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0

    Measured: Up to 2 year

Secondary outcomes (8)

  1. Time to hematologic response

    Time from randomization to first documentation of hematologic response

    Measured: Up to 2 year

  2. Hematologic best response

    Best Hematologic response allowed at study entry according to central laboratory results and International Society of Amyloidosis criteria as evaluated by an AC

    Measured: Up to 2 year

  3. Duration of hematologic response

    Time from the date of first documentation of hematologic response to the date of first documented hematologic disease progression, respectively according to central laboratory results and ISA criteria as determined by an AC

    Measured: Up to 2 year

  4. Hematologic response rate

    Overall hematologic (CR + VGPR + PR) response rate based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as evaluated by an AC

    Measured: Up to 2 year

  5. Overall survival

    Time from randomization to date of death. Patients without documentation of death at the time of analysis were censored at the date last known to be alive

    Measured: Up to 5 year

  6. Progression-free survival

    Time from randomization to date of hematologic progression. Patients without documentation of death at the time of analysis were censored at the date last known to be alive

    Measured: Up to 5 year

  7. Vital organ best response

    Best response in the vital organs allowed at study entry (heart and kidney) according to central laboratory results and International Society of Amyloidosis criteria as evaluated by an AC

    Measured: Up to 2 year

  8. Vital organ progression-free survival

    Time from randomization to first documentation of vital organ (heart or kidney) progression* or death due to any cause, whichever occurred first. Patients without documentation of vital organ (heart or kidney) progression* were censored at the date of last organ assessment of stable disease or better

    Measured: Up to 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single-arm multi-center trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06769555
Sponsor's protocol ID
IIT2024012
Status last verified
Apr 2026
First submitted
10 Dec 2024
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CM-336 BCMA/CD3 bispecific antibody in people with AL Amyloidosis, run by Institute of Hematology & Blood Diseases Hospital, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematologic response VGPR or better rate after four cycles (time frame: Four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06769555.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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