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CAR T-cell Therapy

CAR T Cells for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by Juno Therapeutics, a Subsidiary of Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with confirmed progressive disease within 6 months prior to start of Screening and who are refractory (or non-responsive) to their most recent anti-myeloma treatment regimen afterwards will be also eligible

Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior antimyeloma treatment regimens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after cc-98633 infusion

Awards & highlights

Study Summary

This trial is testing a new cancer treatment called CC-98633 for people with multiple myeloma who have relapsed or are refractory to other treatments. The goal of the trial is to find the recommended Phase 2 dose (RP2D) of CC-98633, as well as to evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633. The trial will be conducted in two parts: dose-escalation (Part A) and dose-expansion (Part B).

Who is the study for?

Adults over 18 with relapsed/refractory multiple myeloma who've had a stem cell transplant, treatments including immunomodulatory agents, proteasome inhibitors, and anti-CD38. They must have measurable disease progression post-treatment and adequate organ function. Excluded are those with prior BCMA-targeted therapy, CAR T-cell therapy, active autoimmune diseases needing suppression, uncontrolled infections or certain CNS conditions.Check my eligibility

What is being tested?

The trial is testing CC-98633 CAR T Cells in two parts: Part A to find the safest dose (dose-escalation) and Part B to test this dose further for safety and effectiveness (dose-expansion). Participants' responses will be monitored closely throughout the study.See study design

What are the potential side effects?

Potential side effects may include immune system reactions causing inflammation in various organs, infusion-related reactions similar to allergic responses during treatment administration, fatigue due to immune activation by the treatment, as well as potential risks associated with bone marrow suppression.

Eligibility Criteria

Inclusion Criteria

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

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My myeloma has worsened in the last 6 months despite treatment.

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I have undergone at least 3 different treatments for my myeloma.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I've had a stem cell transplant and treatments including immunotherapy, proteasome inhibitor, and anti-CD38.

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I am 18 years old or older.

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My multiple myeloma has returned or is not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after cc-98633 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years after cc-98633 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after cc-98633 infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events (AEs)

Secondary outcome measures

Complete Response (CR) Rate

Duration of response (DOR)

Overall Response Rate (ORR)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CC-98633Experimental Treatment1 Intervention

Subjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor

11 Previous Clinical Trials

1,304 Total Patients Enrolled

3 Trials studying Multiple Myeloma

353 Patients Enrolled for Multiple Myeloma

Ashley Koegel, MDStudy DirectorEarly Clinical Development

1 Previous Clinical Trials

80 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,380 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,137 Patients Enrolled for Multiple Myeloma

Media Library

CC-98633 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04394650 — Phase 1

Multiple Myeloma Research Study Groups: CC-98633

Multiple Myeloma Clinical Trial 2023: CC-98633 Highlights & Side Effects. Trial Name: NCT04394650 — Phase 1

CC-98633 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04394650 — Phase 1

Frequently Asked Questions

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

In which locations have the researchers initiated this experiment?

"This clinical trial is presently being conducted in 21 distinct medical centres, including those based in Stanford, Birmingham and Chicago. To reduce travel costs associated with the study, it's best to choose a location closest to you if you decide to participate."

Answered by AI

Is this research endeavor actively seeking participants?

"As evidenced on clinicaltrials.gov, this trial is no longer accepting candidates; it was initially posted on August 18th 2020 and last revised October 18th 2022. However, 807 other medical trials are still actively recruiting patients at present time."

Answered by AI

Has the FDA sanctioned CC-98633 for therapeutic purposes?

"The safety of CC-98633 has been evaluated as a 1 because it is currently in the preliminary stages of clinical trials, with limited data supporting its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma

2020. "A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04394650.