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BCMA/GPRC5D Trispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-004)

ConditionAL Amyloidosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

Systemic light-chain (AL) amyloidosis is a plasma cell disorder characterized by the production of misfolded immunoglobulin light chains that deposit in organs and lead to progressive organ dysfunction. Although daratumumab-based therapy has improved outcomes, a substantial proportion of patients fail to achieve deep hematologic responses.

This is a prospective, single-arm, single-center clinical study evaluating the safety and efficacy of the BCMA/GPRC5D/CD3 trispecific antibody QLS4131 in patients with newly diagnosed systemic AL amyloidosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily provide written informed consent (ICF) prior to any study-specific procedures.

Age ≥18 years, regardless of sex.

Newly diagnosed primary systemic light-chain (AL) amyloidosis.

Difference between involved and uninvolved serum free light chains (dFLC) ≥20 mg/L; and

Disqualifiers

Non-AL amyloidosis, including hereditary amyloidosis or any other non-AL subtype.

Symptomatic multiple myeloma.

Grade >2 peripheral neuropathy or Grade ≥2 painful peripheral neuropathy at screening, regardless of current treatment.

History of another malignancy within 5 years before enrollment, except AL amyloidosis.

Trial design

Design model

Single group

Treatments tested in this trial

  • QLS4131

    Drug

    QLS4131 is an investigational GPRC5D/BCMA/CD3 trispecific antibody administered by subcutaneous injection. The study uses a step-up dosing schedule followed by full-dose maintenance treatment over 6 to 8 treatment cycles. Supportive care and prophylactic medications for cytokine release syndrome (CRS) are permitted according to the study protocol.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: QLS4131-treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hematologic Complete Response (CR) Rate

Proportion of participants achieving hematologic complete response (CR) according to the International Society of Amyloidosis (ISA) response criteria following treatment with QLS4131.

Time frame
At the end of each 28-day treatment cycle and before the start of the next cycle, through Cycle 8 （each cycle is 28 days)

Secondary outcomes

1

time to hematologic response

Time from the first dose of QLS4131 to the first documented hematologic response.

Time frame
From the first dose until the first documented response, assessed every 2 weeks in Cycle 1 and every 28 days from Cycle 2 through end of treatment (each cycle is 28 days)
2

Duration of Hematologic Response (DOR)

Time from first observed hematologic response to disease progression or death due to disease progression, whichever occurs first.

Time frame
From first documented response until disease progression or death, assessed up to 2 years
3

Overall Hematologic Response Rate (ORR)

Proportion of patients achieving a hematologic response of partial response (PR) or better.

Time frame
From first dose through end of treatment, assessed every 28 days
4

Minimal residual disease (MRD) negativity rate

Proportion of patients achieving bone marrow MRD negativity at a sensitivity of 10-⁵.

Time frame
Bone marrow MRD assessed at the time of suspected hematologic complete response (CR) or dFLC <10 mg/L, up to the end of treatment from first dose

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

This trial is not recruiting at the moment. You can still explore other options: