A Phase 2 Study of JNJ-79635322 in Participants with RRMM

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 May 2026 → ongoing

Decision date (initial)

2026-05-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of JNJ-79635322

Conditions and MedDRA coding

Relapsed or Refractory Multiple Myeloma (RRMM)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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
2. 3. Received at least 3 prior lines of antimyeloma therapy including a PI, an IMiD, and an anti-CD38 mAb.
3. 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.
4. 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)
5. 6. Have an ECOG PS of 0 to 2 at screening and immediately before the start of study treatment administration (Oken 1982).

Exclusion criteria 5

1. 2. Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322 (refer to the IB)
2. 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.
3. 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).
4. 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.
5. 8. Participant has leptomeningeal disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall response rate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 6

Locations

2 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications