Health TrialsbyHealthPanel

BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis

ConditionSystemic Light Chain Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a prospective, single-arm, single-center clinical study designed to evaluate the efficacy and safety of low-dose BCMA/CD3 bispecific antibody (CM336) in patients newly diagnosed with systemic light chain (AL) amyloidosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient is informed of and voluntarily signs the informed consent form (ICF).

Age ≥18 years, regardless of sex.

Confirmed diagnosis of primary light-chain (AL) amyloidosis, in accordance with the Guidelines for the Diagnosis and Treatment of Systemic Light-chain Amyloidosis (2021 Revision).

Difference between involved and uninvolved free light chains (dFLC) ≥50 mg/L, or

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-BCMA/CD3 bispecific antibody

    Drug

    CM336 is a bispecific T-cell engager targeting B-cell maturation antigen (BCMA) and CD3. In this study, CM336 is administered subcutaneously with a step-up dosing strategy in Cycle 1 (3 mg Day 1, 20 mg Day 4, 40 mg Day 8 and onwards weekly). Patients who achieve ≥VGPR by Cycle 4 may switch to 80 mg every two weeks from Cycle 5. The total treatment duration is up to 12 cycles (28 days per cycle), with follow-up for safety and efficacy endpoints including hematologic and organ response.

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: BsAbs-treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Hematologic Very Good Partial Response (VGPR) or Better

Proportion of participants achieving a hematologic response of VGPR or better (≥VGPR) of anti-BCMA/CD3 bispecific antibody (CM336), assessed using consensus criteria for AL amyloidosis hematologic response.

Time frame
4 months
2

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Safety will be assessed by monitoring the incidence, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), graded according to NCI CTCAE v5.0 and ASTCT criteria. Dose interruptions, modifications, or discontinuations due to toxicity will also be recorded.

Time frame
From the first dose through 30 days after the last dose, up to approximately 24 months.

Secondary outcomes

1

Time to First Hematologic Response (TTR)

Time frame
From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.
2

Best Hematologic Response Achieved

The deepest hematologic response (e.g., PR, VGPR, CR, or sCR) observed at any time during the treatment period.

Time frame
From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.
3

Duration of Hematologic Response (DOR)

Time from the first documented hematologic response to disease progression or death, whichever occurs first.

Time frame
From the date of first documented hematologic response to the date of disease progression or death, whichever occurs first, up to approximately 24 months.
4

Overall Response Rate (ORR)

Time frame
The overall response rate (ORR) was evaluated at the end of cycle 4, 6, and 12 (28 days per cycle).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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