ClinicalTrials.gg
Sign In
RecruitingNCT05652335Updated Nov 3, 2026

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

A Phase 1 interventional study of JNJ-79635322 in Relapsed or Refractory Multiple Myeloma and Previously Treated Amyloid Light-chain (AL) Amyloidosis, sponsored by Janssen Research & Development, LLC. Recruiting at 29 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Primary conditionMultiple MyelomaRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Myeloma
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Multiple Myeloma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 11 months later.
Updated Nov 3, 2026Site recruiting status changedGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 126 studies in Multiple Myeloma by Johnson & Johnson — 13 open to participants now, 33 under way, 12 of them phase 3. Multiple Myeloma · Johnson & Johnson.

Planned enrollment
41st of 100
180 · median 125
Started
2022
with 7 others
Phase 1
24 of 126
2 open now
Primary completion
2027-04
later than 12 of 32 live
Registered
109th of 126
by date

Among the 126 studies in Multiple Myeloma by Johnson & Johnson, this one is the 41st largest by planned enrollment of the 100 interventional ones that give a count, is one of 8 that started in 2022, is one of 24 in phase 1, reaches primary completion later than 12 of the 32 other live ones, and was the 109th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

13 of the 126 studies in Multiple Myeloma by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

Spain12
United States10
France9
Israel8
Netherlands8
Australia7
Germany6
Greece6
Japan6
United Kingdom6
China5
Italy5

All 13 open studies →

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 126 studies in Multiple Myeloma by Johnson & Johnson, or all of them as a file.
02

Study summary

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

03

Conditions studied

  • Relapsed or Refractory Multiple Myeloma
  • Previously Treated Amyloid Light-chain (AL) Amyloidosis

Browse trials for

04

In context

Multiple Myeloma Reclassified

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

This study's planned enrollment of 180 is above the median of 41 across 3,008 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 137 (48%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Compared within Multiple Myeloma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For participants with multiple myeloma:

  • Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 , or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
  • Must have an (ECOG) status of 0 or 1
  • Have at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter [cm] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging [MRI] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)

For participants with previously treated AL amyloidosis:

  • Initial histopathological diagnosis of amyloidosis
  • Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
  • Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) >=50 mg/L or difference between involved and uninvolved free light chains (dFLC) >=50 mg/L, or serum m-protein >= 0.5 g/dL
  • One or more organs impacted by systemic AL amyloidosis
  • (LVEF) >=45%

Exclusion criteria

Exclusion Criteria:

For participants with multiple myeloma:

  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
  • Received a cumulative dose of equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days [not applicable for Part 2C participants], or CD3-redirecting therapy within 21 days[not applicable for Part 2B or 2C participants])
  • Prior transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade \<=3)
  • The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency () infection, active or C infection, stroke or seizure within 6 months prior to first dose of study treatment, disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction \<=6 months prior to enrollment, stage III or IV congestive heart failure, et cetera)
  • Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration

For participants with previously treated AL amyloidosis:

  • CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required
  • Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
  • Pulmonary compromise requiring supplemental oxygen use
  • Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions
  • Previous or current diagnosis of symptomatic multiple myeloma
  • Macroglossia that impairs swallowing difficulty
  • Received a cumulative dose of corticosteroids equivalent to > 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)
  • Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to \<=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade \<=3)
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

06

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Part 1: Dose Escalation

    Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

    Drug: JNJ-79635322

  • Experimental
    Part 2: Dose Expansion

    Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

    Drug: JNJ-79635322

Interventions

  • DrugJNJ-79635322

    JNJ-79635322 will be administered as SC injection.

07

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

    DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    Time frame: Up to 2 years 5 months

  2. Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

    An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

    Time frame: Up to 2 years 5 months

  3. Part 2: Number of Participants with Abnormalities in Laboratory Values

    Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.

    Time frame: Up to 2 Years 5 months

Secondary outcomes

  1. Serum Concentration of JNJ-79635322

    Serum samples will be analyzed to determine concentrations of JNJ-79635322.

    Time frame: Up to 2 Years 5 months

  2. Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322

    Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.

    Time frame: Up to 2 Years 5 months

  3. Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria

    Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.

    Time frame: Up to 2 Years 5 months

  4. Time to Response (TTR) as Defined by IMWG 2016 Response Criteria

    TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for partial response (PR) or better as defined by IMWG 2016 response criteria.

    Time frame: Up to 2 Years 5 months

  5. Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria

    DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.

    Time frame: Up to 2 Years 5 months

  6. Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria

    TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by International Amyloidosis Consensus Criteria.

    Time frame: Up to 2 Years 5 months

  7. Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria

    DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first.

    Time frame: Up to 2 Years 5 months

  8. Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria

    Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria.

    Time frame: Up to 2 Years 5 months

08

Study locations

25 of 29 sites recruiting
09

References and documents

Publications

  • Pillarisetti K, Yang D, Luistro L, Yao J, Smith M, Vulfson P, Testa JS, Ponticiello R, Brodeur S, Heidrich B, Packman K, Singh S, Attar R, Elsayed Y, Philippar U. Ramantamig (JNJ-79635322), a novel T-cell-engaging trispecific antibody targeting BCMA, GPRC5D, and CD3, in multiple myeloma models. Blood. 2026 Feb 19;147(8):834-847. doi: 10.1182/blood.2025030027. PubMed 41100731 ↗

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Data sharing details ↗ · www.janssen.com

10

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Apr 2027, 52 months after the start.

Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 52 months is above that.

Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2022
First posted
Dec 15, 2022
StartActual
Nov 22, 2022
Primary completionEst.
Apr 19, 2027
CompletionEst.
Nov 15, 2030
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites changed recruiting status (2 now active, not recruiting)
Show 2 sites
  • Japanese Red Cross Medical Center · Shibuya City, JapanRecruiting→Active, not recruiting
  • Osaka University Hospital · Suita-shi, JapanRecruiting→Active, not recruiting
Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    2 sites changed recruiting status (2 now active, not recruiting)
    Show 2 sites
    • Japanese Red Cross Medical Center · Shibuya City, JapanRecruiting→Active, not recruiting
    • Osaka University Hospital · Suita-shi, JapanRecruiting→Active, not recruiting
    + 1 other change: verification date
  2. Sep 28, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05652335
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Dec 15, 2022
Start date
Nov 22, 2022
Primary completion
Apr 19, 2027 (estimated)
Completion
Nov 15, 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ramantamig

Other studies in this condition

Multiple Myeloma →

Other studies from this sponsor

Janssen Research & Development, LLC →

Start the discussion