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CAR T-cell Therapy

JNJ-68284528 for Multiple Myeloma (CARTITUDE-1 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380
Awards & highlights

CARTITUDE-1 Trial Summary

This trial is testing a new drug to see if it is safe and effective.

Eligible Conditions
  • Multiple Myeloma

CARTITUDE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Number of Participants With Adverse Events as Per Severity
Phase 2: Overall Response Rate (ORR)
Secondary outcome measures
Number of Participants With Depletion of BCMA Expressing Cells
Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528
+29 more

Side effects data

From 2022 Phase 1 & 2 trial • 126 Patients • NCT03548207
94%
Neutropenia
87%
Cytokine Release Syndrome
84%
Anaemia
75%
Thrombocytopenia
59%
Leukopenia
51%
Lymphopenia
44%
Fatigue
43%
Hypocalcaemia
38%
Cough
37%
Decreased Appetite
35%
Hypophosphataemia
31%
Nausea
31%
Hypoalbuminaemia
29%
Hyponatraemia
28%
Diarrhoea
26%
Aspartate Aminotransferase Increased
25%
Pyrexia
25%
Chills
25%
Hypokalaemia
22%
Hypertension
22%
Alanine Aminotransferase Increased
21%
Dizziness
21%
Oedema Peripheral
21%
Headache
21%
Constipation
21%
Vomiting
18%
Hypotension
18%
Hypomagnesaemia
18%
Sinus Tachycardia
18%
Blood Lactate Dehydrogenase Increased
16%
Immune Effector Cell-Associated Neurotoxicity Syndrome
16%
Hypogammaglobulinaemia
16%
Hypofibrinogenaemia
16%
Gamma-Glutamyltransferase Increased
16%
Insomnia
16%
Arthralgia
16%
Nasal Congestion
15%
Blood Alkaline Phosphatase Increased
15%
Pain in Extremity
13%
Back Pain
12%
International Normalised Ratio Increased
12%
Hyperglycaemia
12%
Rhinorrhoea
12%
Dyspnoea
10%
Muscular Weakness
10%
Flushing
9%
Upper Respiratory Tract Infection
9%
Febrile Neutropenia
9%
Abdominal Pain
7%
Serum Ferritin Increased
7%
Dehydration
7%
Anosmia
7%
Pleural Effusion
7%
Myalgia
7%
Epistaxis
6%
Wheezing
6%
Dysgeusia
6%
Micrographia
6%
Sepsis
6%
Pneumonia
6%
Sinus Bradycardia
6%
Influenza
6%
Activated Partial Thromboplastin Time Prolonged
6%
Hypoglycaemia
6%
Musculoskeletal Pain
6%
Tremor
6%
Musculoskeletal Chest Pain
6%
Confusional State
6%
Productive Cough
6%
Deep Vein Thrombosis
4%
Parkinsonism
4%
Mental Status Changes
4%
Peripheral Sensory Neuropathy
4%
Oropharyngeal Pain
3%
Rhinovirus Infection
3%
Neurotoxicity
3%
Asthenia
3%
Pain
3%
Acute Kidney Injury
3%
Hypoxia
3%
Sinusitis
3%
Weight Decreased
3%
Muscle Spasms
3%
Memory Impairment
3%
Dyspnoea Exertional
1%
Herpes Zoster
1%
Herpes Zoster Disseminated
1%
Cranial Nerve Paralysis
1%
Lung Abscess
1%
Perirectal Abscess
1%
Skin Infection
1%
Pericardial Effusion
1%
Neuralgia
1%
Staphylococcal Infection
1%
Peripheral Motor Neuropathy
1%
Somnolence
1%
Syncope
1%
Atrial Fibrillation
1%
Haematochezia
1%
Cholecystitis Acute
1%
Blood Creatinine Increased
1%
Tumour Lysis Syndrome
1%
Bacterial Sepsis
1%
Septic Shock
1%
Supraventricular Tachycardia
1%
Diplopia
1%
Hyperbilirubinaemia
1%
Malaise
1%
Respiratory Failure
1%
Acute Respiratory Failure
1%
Bacteraemia
1%
Lymphocytosis
1%
Pruritus
1%
Anxiety
1%
Pollakiuria
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 (US Population)
Phase 2 (Japan Population)
Phase 1b (US Population)

CARTITUDE-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: JNJ-68284528Experimental Treatment1 Intervention
After lymphodepletion JNJ-68284528 will be administered as a single infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-68284528
2018
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,182 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,291 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,779 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,258 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma
2018. "A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03548207.
~19 spots leftby Apr 2025
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