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


NCT ID: NCT05000450
Sponsor Protocol Number: ALLO-605-201

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

- Autologous stem cell transplantation within last 6 weeks prior to the start of

- Any prior allogeneic hematopoietic stem cell transplantation

- Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion

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