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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Study of bb21217 in Multiple Myeloma

  • Clinicaltrials.gov identifier

    NCT03274219

  • Recruitment Status

    Active, not recruiting

  • First Posted

    September 6, 2017

  • Last update posted

    March 18, 2021

Study Description

Brief summary:

Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).

  • Condition or Disease:
  • Intervention/Treatment:
  • Phase: Phase 1

Detailed Description

Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (bb21217). Following manufacture of the drug product, subjects will receive lymphodepletion prior to bb21217 infusion. All subjects will then be followed for up to 60 months in Study CRB-402. All subjects who complete the study, as well as those who withdraw from the study after receiving bb21217 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 72 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma
  • Actual Study Start Date: August 2017
  • Estimated Primary Completion Date: October 2025
  • Estimated Study Completion Date: October 2025

Outcome Measures

Eligibility Criteria

  • Ages Eligible for Study:
  • Sexes Eligible for Study:
  • Accepts Healthy Volunteers:

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

More Information

  • Responsible Party:
  • ClinicalTrials.gov Identifier: NCT03274219 History of Changes
  • Other Study ID Numbers:
  • First Posted: September 6, 2017 Key Record Dates
  • Last Update Posted: March 18, 2021
  • Last Verified: March 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No