Ramantamig (JNJ-79635322), a novel T-cell-engaging trispecific antibody targeting BCMA, GPRC5D, and CD3, in multiple myeloma models.
Kodandaram Pillarisetti, Danlin Yang, Leopoldo Luistro...
https://pubmed.ncbi.nlm.nih.gov/41100731Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05652335
Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
180
Participants Needed
29
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying JNJ-79635322, a trispecific antibody, in adults with relapsed or refractory multiple myeloma or previously treated AL amyloidosis. The trial aims to find the recommended phase 2 dose (RP2D) and schedule that are safe during the dose escalation phase and then to evaluate safety and tolerability at that dose in different patient subgroups. This early phase 1 trial focuses on understanding how the drug behaves in these conditions and monitoring its effects on participants. Participants will receive JNJ-79635322 through subcutaneous injection. The study has two parts: Part 1 involves gradually increasing the dose to identify the RP2D regimen(s). Part 2 involves giving the selected dose(s) to participants to further study safety and tolerability in specific disease subgroups. Dose escalation and expansion allow researchers to characterize the drug’s effects and adjust dosing accordingly. During the study, participants will be closely monitored for dose-limiting toxicities, adverse events, and laboratory abnormalities over a period of up to 2 years and 5 months. Various assessments include measuring serum drug concentrations, checking for anti-drug antibodies, and evaluating preliminary anticancer activity using recognized response criteria for multiple myeloma and amyloidosis. The study involves regular safety and efficacy evaluations to understand the drug’s impact and how participants respond over time.
CONDITIONS
Brief Title
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma according to International Myeloma Working Group (IMWG) criteria
- For Part 1: Relapsed or refractory disease treated with a proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy with at least 3 prior therapy lines or refractory regardless of prior lines
- For Part 2: Relapsed or refractory disease treated with a proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Measurable disease at screening by serum or urine M-protein, serum free light chain criteria, or extramedullary disease confirmed by imaging (Part 2C participants not required to have measurable disease)
- Diagnosed with previously treated AL amyloidosis with histopathological confirmation
- Not candidates for available AL amyloidosis therapy with clinical benefit and have received prior therapy cycles
- Measurable disease at screening with serum involved free light chain or M-protein levels
- One or more organs affected by systemic AL amyloidosis
- Left ventricular ejection fraction (LVEF) of 45% or higher
You will not qualify if you...
- Central nervous system involvement or signs of meningeal involvement of multiple myeloma or AL amyloidosis
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
- Received corticosteroids equivalent to more than 140 mg prednisone within 14 days before study treatment
- Recent prior antitumor therapy within specified timeframes before study treatment
- Prior allogeneic transplant within 6 months or autologous transplant within 12 weeks before study treatment
- Live attenuated vaccine within 4 weeks before first dose
- Non-hematologic toxicity from prior anticancer therapy not resolved to baseline or Grade 1 or better
- Medical conditions including pulmonary compromise requiring oxygen, HIV infection, active hepatitis B or C, recent stroke or seizure, autoimmune disease, serious infections, uncontrolled fungal infection, or significant cardiac conditions
- For AL amyloidosis: macroglossia impairing swallowing
- Progressive or refractory disease per IMWG after CAR-T administration (Part 2C)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years and 5 months
Participants receive JNJ-79635322 by subcutaneous injection during dose escalation or at the recommended phase 2 dose regimen.
Visits occur regularly during treatment for dosing and monitoring
Trial Site Locations
Total: 29 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
5
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Levine Cancer Institute
Charlotte, North Carolina, United States, 28001
Actively Recruiting
8
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
11
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
12
CHU de Liege
Liège, Belgium, 4000
Actively Recruiting
13
CHU Nantes
Nantes, France, 44093
Actively Recruiting
14
CHU Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
15
Chu Rennes Hopital Pontchaillou
Rennes, France, 35000
Completed
16
Institut Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
17
Japanese Red Cross Medical Center
Shibuya City, Japan, 150-8935
Actively Recruiting
18
Osaka University Hospital
Suita-shi, Japan, 565-0871
Actively Recruiting
19
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Completed
20
VUMC Amsterdam
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
21
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
22
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
23
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
24
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
25
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
26
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Actively Recruiting
27
Hosp Clinico Univ de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
28
University College Hospital
London, United Kingdom, W1T 7HA
Actively Recruiting
29
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
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Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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