Open Actively Recruiting

Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

About

Brief Summary

The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Documented diagnosis of relapsed/refractory multiple myeloma (MM)
  • Subjects must have measurable disease
  • Subjects must have received ≥3 prior MM lines of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, renal, liver, pulmonary, and cardiac functions
  • Life expectancy of at least 3 months without treatment

Exclusion Criteria:

  • Subjects with known active or history of central nervous system (CNS) or leptomeningeal involvement of myeloma or plasma cell leukemia
  • Current or history of thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
  • Autologous stem cell transplantation within last 6 weeks prior to the start of lymphodepletion
  • Any prior allogeneic hematopoietic stem cell transplantation
  • Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion

Join this Trial

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Study Stats
Protocol No.
21-001960
Category
Hematology-Oncology
Oncology
Contact
ANNABEL LIU
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05000450
For detailed technical eligibility, visit ClinicalTrials.gov.