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CAR T-cell Therapy

CB-011 for Multiple Myeloma (CaMMouflage Trial)

Phase 1

Recruiting

Research Sponsored by Caribou Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group performance status grade of 0 or 1.

Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

CaMMouflage Trial Summary

This trial studies a new cancer therapy to treat relapsed/refractory multiple myeloma. It will assess safety and effectiveness.

Who is the study for?

This trial is for adults with multiple myeloma that has returned or isn't responding to treatment. They must have tried at least three types of treatments, including specific inhibitors and antibodies. Good performance status and organ function are required. People who've had certain stem cell transplants recently, previous CAR-T therapy, CNS involvement, recent stroke or seizure, HIV, live vaccines within 4 weeks before the study starts, or hepatitis B/C can't join.Check my eligibility

What is being tested?

The trial is testing CB-011: a new type of 'off-the-shelf' CAR-T cell therapy targeting BCMA in patients whose multiple myeloma has relapsed or is refractory. It's a Phase 1 study focusing on safety and finding the right dose while also checking how well it works against this cancer.See study design

What are the potential side effects?

While not specified here, typical side effects for CAR-T therapies may include flu-like symptoms (fever, fatigue), risk of infection due to low blood cell counts, neurological issues (confusion or difficulty speaking), and an immune reaction called cytokine release syndrome.

CaMMouflage Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or can carry out light work.

Select...

I've had 3 or more treatments for my multiple myeloma, including a PI, an IMiD, and an anti-CD38.

Select...

My multiple myeloma has returned or didn't respond to treatment, and it can be measured.

CaMMouflage Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 A) Number of patients with dose limiting toxicities (DLT)

(Part B) Overall Response Rate (ORR)

CaMMouflage Trial Design

1Treatment groups

Experimental Treatment

Group I: CB-011Experimental Treatment1 Intervention

Part A Escalation with CB-011 in ascending doses using a traditional 3+3 design. Part B Expansion. Up to 30 participants will be enrolled to receive CB-011 at the RDE/MTD and/or RP2D determined in Plan A

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Caribou Biosciences, Inc.Lead Sponsor

3 Previous Clinical Trials

242 Total Patients Enrolled

Media Library

CB-011 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05722418 — Phase 1

Multiple Myeloma Research Study Groups: CB-011

Multiple Myeloma Clinical Trial 2023: CB-011 Highlights & Side Effects. Trial Name: NCT05722418 — Phase 1

CB-011 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05722418 — Phase 1

Frequently Asked Questions

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

Has the Food and Drug Administration granted approval for CB-011?

"Due to the Phase 1 nature of this trial, with limited data validating safety and efficacy, CB-011 received a score of 1."

Answered by AI

Are there any remaining vacancies to join this research endeavor?

"According to the clinicaltrials.gov listing, this trial is not currently accepting participants. Initial posting was on February 1st and the last update made was on February 2nd of 2023. While no longer recruiting for this particular study, there are 803 other trials now in search of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

2023. "CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05722418.