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Monoclonal Antibodies

Dose Escalation (Part 1) and Dose Expansion (Part 2) for Myeloproliferative Disorder

Q: How many participants are involved in the experiment?

Affirmative. According to clinicaltrials.gov, this research is actively recruiting patients since it was posted on December 11th 2023 and updated most recently on December 5th 2023. The trial requires 100 participants at a single site.

Q: Are there currently vacancies for participants in this medical investigation?

According to the information posted on clinicaltrials.gov, this <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> medical research is still recruiting participants for participation. It was initially published in December 11th 2023 and updated most recently on December 5th of the same year.

Q: Have the FDA sanctioned both components of this pharmacological trial?

Our team at Power has assigned a rating of 1 to the safety and efficacy of Dose Escalation (Part 1) and Dose Expansion (Part 2), as this is only in the early stage Phase I trial. Thus, there is limited data available on these two factors.

Q: What objectives are being sought in this research endeavor?

The primary endpoint of this trial, estimated to take up to two years, is the number of participants who experience dose-limiting toxicities. Secondary metrics include an assessment of anti-drug antibodies produced against JNJ-88549968; time it takes for responses such as CR or PR to manifest; and serum concentrations of JNJ-88549968 in patient samples.

Phase 1

Recruiting

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 greater than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent

Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial studies safety & optimal dosing of JNJ-88549968, to determine the right dose & schedule.

Who is the study for?

This trial is for adults with a specific mutation called CALR in their blood cells, leading to conditions like thrombocytosis and myelofibrosis. They should be able to perform daily activities with ease or only have slight limitations (ECOG <=2). The study excludes details not provided.Check my eligibility

What is being tested?

The trial tests JNJ-88549968's safety and the best dose for treating certain blood disorders. It has two parts: finding the right dose (Dose Escalation) and then seeing how safe it is at that dose (Cohort Expansion).See study design

What are the potential side effects?

Specific side effects of JNJ-88549968 are not listed, but generally, such treatments may cause fatigue, nausea, bruising or bleeding risks, liver issues, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old or the legal age of majority where the study is conducted.

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My blood disorder is due to a specific CALR mutation.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 and 2: Number of Participants with Adverse Events (AEs)

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

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Secondary outcome measures

Part 1 and 2: Complete Response (CR) Rate

Part 1 and 2: Duration of Response (DOR)

Part 1 and 2: Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation (Part 1) and Dose Expansion (Part 2)Experimental Treatment1 Intervention

In dose escalation (Part 1), participants will receive JNJ-88549968. The dose will be escalated sequentially to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule(s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. In dose expansion (Part 2), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,592 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,178 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in the experiment?

"Affirmative. According to clinicaltrials.gov, this research is actively recruiting patients since it was posted on December 11th 2023 and updated most recently on December 5th 2023. The trial requires 100 participants at a single site."

Answered by AI

Are there currently vacancies for participants in this medical investigation?

"According to the information posted on clinicaltrials.gov, this experimental medical research is still recruiting participants for participation. It was initially published in December 11th 2023 and updated most recently on December 5th of the same year."

Answered by AI

Have the FDA sanctioned both components of this pharmacological trial?

"Our team at Power has assigned a rating of 1 to the safety and efficacy of Dose Escalation (Part 1) and Dose Expansion (Part 2), as this is only in the early stage Phase I trial. Thus, there is limited data available on these two factors."

Answered by AI

What objectives are being sought in this research endeavor?

"The primary endpoint of this trial, estimated to take up to two years, is the number of participants who experience dose-limiting toxicities. Secondary metrics include an assessment of anti-drug antibodies produced against JNJ-88549968; time it takes for responses such as CR or PR to manifest; and serum concentrations of JNJ-88549968 in patient samples."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

2023. "A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06150157.

All > Essential Thrombocythemia > Myelofibrosis