IGG1 TRISPECIFIC MONOCLONAL ANTIBODY AGAINST T-CELL RECEPTOR CD3, B-CELL MATURATION ANTIGEN AND G PROTEIN-COUPLED RECEPTOR CLASS C GROUP 5 MEMBER D for Relapsed or Refractory Multiple Myeloma

Inclusion criteria

• {"criterion_text":"- 2.1. Documented diagnosis of MM as defined by the criteria below: a. MM diagnosis according to the IMWG diagnostic criteria (Rajkumar 2014). b. Measurable disease at screening as assessed by central laboratory, defined by any of the following: i. Serum M-protein level ≥0.5 g/dL; or ii. Serum Ig FLC ≥10 mg/dL and abnormal serum IgκλFLC ratio; or iii. Urine M-protein level ≥200 mg/24h"}
• {"criterion_text":"- 3. Received at least 3 prior lines of antimyeloma therapy including a PI, an IMiD, and an anti-CD38 mAb."}
• {"criterion_text":"- 4.1. Documented evidence of PD or failure to achieve a response (ie, PR or better) to the last line of therapy based on investigator’s determination of response by the IMWG criteria."}
• {"criterion_text":"- 5. Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent. Toxicity related to prior anticancer treatment must have resolved to Grade 1 or better (except alopecia, skin fibrosis or discoloration, dry mouth, endocrinopathy managed with replacement therapy, peripheral neuropathy, and dysgeusia, which must be Grade 2 or better)"}
• {"criterion_text":"- 6. Have an ECOG PS of 0 to 2 at screening and immediately before the start of study treatment administration (Oken 1982)."}

Exclusion criteria

• {"criterion_text":"- 2. Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322 (refer to the IB)"}
• {"criterion_text":"- 3.1. Had major surgery within 2 weeks before first dose or has planned major surgery during study Treatment Phase. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate."}
• {"criterion_text":"- 6. Participant has a prior or concurrent second malignancy (other than the disease under study) the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s) (see Section 10.5 on Allowed Recent Second or Prior Malignancies for details)."}
• {"criterion_text":"- 7. Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required."}
• {"criterion_text":"- 8. Participant has leptomeningeal disease"}

Primary endpoints

• {"endpoint_text":"- Overall response rate","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

16-04-2026

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

28

Number Of Sites

9

Number Of Participants

28

Poland

Primary sponsor

Full Name

Janssen Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Iqvia Inc.

Responsibilities

SDTM programming

Name

4g Clinical LLC

Responsibilities

IWRS/RTSM vendor

Name

Labcorp Central Laboratory Services SARL

Responsibilities

central laboratory

Name

SGS Belgium

Responsibilities

PK Office (PK data analysis only)

Name

Labcorp Central Laboratory Services LP

Responsibilities

central laboratory

Name

Pharmaceutical Research Associates Group B.V.

Responsibilities

PK analysis/ADA Services (actual analyses)

Third parties

• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"SDTM programming","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IWRS/RTSM vendor","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"central laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"PK Office (PK data analysis only)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"central laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"PK analysis/ADA Services (actual analyses)","organisation_type":"Pharmaceutical company"}