[M24-209] An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of ABBV-383 in AL Amyloidosis

JRCT ID: jRCT2071230131

Registered date:28/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Immunoglobulin Light Chain (AL) Amyloidosis
• Date of first enrollment: 24/04/2024
• Target sample size: 76
• Countries of recruitment: United States of America,Japan,France,Japan,Australia,Japan,Greece,Japan
• Study type: Interventional

Intervention(s)

Drug: ABBV-383 Intravenous Infusion (Other Names: TNB-383B)

This study in broken into 2 parts (dose escalation and safety expansion) with 5 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses.
After completion of the dose escalation portion of the study, the safety expansion (part 2) portion of the study will begin. Two arms (arm 4-5) will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion (part 1).
Participants will receive ABBV-383 as an infusion into the vein for up to approximately 2 year study duration.

Outcome(s)

• Primary Outcome: Number of Participants with Dose-Limiting Toxicities (DLT) [Time Frame: Up to 28 Days]

Secondary Outcome

1. Percentage of Participants who Achieve Hematologic Complete Response (CR) [Time Frame: Up to 3 Years]
- Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the International Amyloidosis Consensus Criteria (IACC).
2. Overall Hematologic Response (OHR) [Time Frame: Up to 3 Years]
- OHR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR), proportion of participants who achieved a PR or better, per the modified IACC.
3. Time to Hematologic CR [Time Frame: Up to 3 Years]
- Time to hematologic CR is defined as the time from first dose of study drug until CR, per the modified IACC.
4. Duration of Hematologic CR [Time Frame: Up to 3 Years]
- Duration of hematologic CR is defined as the time from CR until disease progression, per the modified IACC.
5. Organ Response Rate (OrRR) [Time Frame: Up to 3 Years]
- Organ response rate is defined as the time from first dose of study drug until to response in the heart kidney and liver, per the modified IACC.
6. Time to Organ Response [Time Frame: Up to 3 Years]
- Time to organ response is defined as the time from first dose of study drug until organ response, per the modified IACC.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis.
2. Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
3. Have at least 1 organ historically impacted by AL amyloidosis.
4. Considered AL amyloidosis risk stage 1, 2, or 3a and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) >= 50 mg/L.
5. Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.

Exclude criteria

1. Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
2. Known allergic reaction, significant sensitivity, or intolerance to constituents of the study drugs (and excipients) and/or other products in the same class.
3. Participant has the following conditions
i. Other non-AL amyloid disease
ii. Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, >= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium > 11 mg/dL)
iii. Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or > 2.0 X 109/L circulating plasma cells by standard differential)
iv. Waldenstrom's macroglobulinemia
v. Acute diffuse infiltrative pneumopathy
vi. Major surgery within 28 days prior first dose or planned during study participation
vii. History of organ transplant requiring continued use of immunosuppressants
viii. Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral)
ix. Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study drug treatment.

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary ID(s): NCT06158854