A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2)

Last Updated January 23, 2025

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CR108581

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2

2
Sites
39 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

CONDITIONS

Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

* Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines
* Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or <=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
* Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
* Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation
* Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (>=) 5.5 milligrams per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population
* Cohort F:
* Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria
* Received initial therapy as specified below. The dose/schedule of cycles administered will be as per standard of care. It is acceptable for up to 1 cycle of the protocol-specified regimens to be missing one of the listed agents (example, held due to toxicity). Acceptable combinations include: At least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; at least 4 to 8 cycles of initial therapy with daratumumab, lenalidomide and dexamethasone (D-Rd) or; at least 4 to 8 cycles of initial therapy with a carfilzomib-based triplet or quadruplet regimen
* Cohort G: Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: a) Ineligibility due to advanced age; or b) Ineligibility due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or c) Subject refusal of high-dose chemotherapy with ASCT as initial treatment
* Cohort H: Considered a candidate for high-dose chemotherapy with ASCT as initial treatment
* Cohorts A, B, C, E, G, H:
* Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligrams (mg)/24 hours
* Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
* Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)*1 cm is required
* Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria
* Cohorts A, B, C, D, E, F, G, H: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Exclusion Criteria:

* Cohorts A, B, D, F: Any therapy that is targeted to BCMA
* Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
* Cohorts A, B, C, D, F:
* Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
* Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis
* Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder
* Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
* Cohorts F, G, and H: Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: a) non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured; b) skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; c) non-invasive cervical cancer treated within the last 24 months that is considered completely cured; d) localized prostate cancer (N0M0): with a Gleason score of greater than or equal to (=>)6, treated within the last 24 months or untreated and under surveillance, with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence, e) breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence; f) malignancy that is considered cured with minimal risk of recurrence
* Cohorts E, G, and H: Frailty index of >= 2 according to Myeloma Geriatric Assessment score

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Belgium, France, Germany, Israel, Netherlands, Saudi Arabia, Spain

Country (8)	City or Province (39)	Status
United States	San Francisco University of California San Francisco	ACTIVE_NOT_RECRUITING
United States	Atlanta Emory University	ACTIVE_NOT_RECRUITING
United States	Chicago University of Chicago	COMPLETED
United States	Iowa City University of Iowa Hospitals & Clinics	RECRUITING
United States	Westwood University of Kansas Cancer Center	RECRUITING
United States	Louisville Norton Cancer Institute	RECRUITING
United States	Boston Dana Farber Cancer Institute	COMPLETED
United States	Detroit Barbara Ann Karmanos Cancer Institute	RECRUITING
United States	Saint Louis Washington University School Of Medicine	ACTIVE_NOT_RECRUITING
United States	Hackensack Hackensack University Medical Center	COMPLETED
United States	New Brunswick Rutgers Cancer Institute of New Jersey	COMPLETED
United States	Bronx Montefiore Medical Center	COMPLETED
United States	Buffalo Roswell Park Cancer Institute	ACTIVE_NOT_RECRUITING
United States	New York Memorial Sloan-Kettering Cancer Center	ACTIVE_NOT_RECRUITING
United States	Philadelphia Thomas Jefferson University	RECRUITING
United States	Dallas University of Texas Southwestern Medical Center	RECRUITING
Belgium	Gent UZ Gent	ACTIVE_NOT_RECRUITING
Belgium	Leuven UZ Leuven	ACTIVE_NOT_RECRUITING
France	Nantes C.H.U. Hotel Dieu - France	COMPLETED
France	Paris cedex 10 Hopital Saint Louis	ACTIVE_NOT_RECRUITING
Germany	Hamburg Universitaetsklinikum Hamburg Eppendorf	ACTIVE_NOT_RECRUITING
Germany	Wuerzburg Universitatsklinikum Wurzburg	ACTIVE_NOT_RECRUITING
Israel	Ramat Gan Sheba Medical Center Tel Hashomer	COMPLETED
Israel	Tel-Aviv Tel-Aviv Sourasky Medical Center	ACTIVE_NOT_RECRUITING
Netherlands	Amsterdam VU Medisch Centrum	ACTIVE_NOT_RECRUITING
Netherlands	Groningen University Medical Center Groningen	ACTIVE_NOT_RECRUITING
Saudi Arabia	Riyadh King Faisal Specialist Hospital & Research Center	ACTIVE_NOT_RECRUITING
Spain	Pamplona Clinica Univ. de Navarra	ACTIVE_NOT_RECRUITING
Spain	Salamanca Hosp Clinico Univ de Salamanca	ACTIVE_NOT_RECRUITING
United States	Tampa Moffitt Cancer Center	RECRUITING
United States	Chicago Northwestern University	COMPLETED
United States	Indianapolis Indiana University	RECRUITING
United States	Rochester Mayo Clinic Rochester	RECRUITING
United States	New York Mount Sinai Medical Center	RECRUITING
United States	Charlotte Levine Cancer Institute, Carolinas HealthCare System	RECRUITING
United States	Philadelphia University of Pennsylvania	RECRUITING
United States	Pittsburgh University of Pittsburgh	RECRUITING
United States	Seattle Fred Hutchinson Cancer Center	RECRUITING
France	Lille CHRU de Lille Hopital Claude Huriez	COMPLETED

Geo Locations

37.77493, -122.41942

33.749, -84.38798

41.85003, -87.65005

41.66113, -91.53017

39.04056, -94.6169

38.25424, -85.75941

42.35843, -71.05977

42.33143, -83.04575

38.62727, -90.19789

40.88593, -74.04347

40.48622, -74.45182

40.84985, -73.86641

42.88645, -78.87837

40.71427, -74.00597

39.95233, -75.16379

32.78306, -96.80667

51.05, 3.71667

50.87959, 4.70093

47.21725, -1.55336

48.85341, 2.3488

53.57532, 10.01534

49.79391, 9.95121

32.08227, 34.81065

32.08088, 34.78057

52.37403, 4.88969

53.21917, 6.56667

24.68773, 46.72185

42.81687, -1.64323

40.96882, -5.66388

27.94752, -82.45843

41.85003, -87.65005

39.76838, -86.15804

44.02163, -92.4699

40.71427, -74.00597

35.22709, -80.84313

39.95233, -75.16379

40.44062, -79.99589

47.60621, -122.33207

50.63297, 3.05858

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

37.77493, -122.41942

33.749, -84.38798

41.85003, -87.65005

41.66113, -91.53017

39.04056, -94.6169

38.25424, -85.75941

42.35843, -71.05977

42.33143, -83.04575

38.62727, -90.19789

40.88593, -74.04347

40.48622, -74.45182

40.84985, -73.86641

42.88645, -78.87837

40.71427, -74.00597

39.95233, -75.16379

32.78306, -96.80667

51.05, 3.71667

50.87959, 4.70093

47.21725, -1.55336

48.85341, 2.3488

53.57532, 10.01534

49.79391, 9.95121

32.08227, 34.81065

32.08088, 34.78057

52.37403, 4.88969

53.21917, 6.56667

24.68773, 46.72185

42.81687, -1.64323

40.96882, -5.66388

27.94752, -82.45843

41.85003, -87.65005

39.76838, -86.15804

44.02163, -92.4699

40.71427, -74.00597

35.22709, -80.84313

39.95233, -75.16379

40.44062, -79.99589

47.60621, -122.33207

50.63297, 3.05858

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