anitocabtagene-autoleucel: Chimeric Antigen Receptor T cells
Study summary
Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease
* Documented measurable disease
* Adequate organ function
* Life expectancy \> 12 weeks, Eastern Cooperative Group Performance Status 0-1
Exclusion Criteria:
* Plasma Cell Leukemia or History of Plasma Cell Leukemia
* Patients with a history of severe hypersensitivity to DMSO should be excluded
* Contraindication to fludarabine or cyclophosphamide
* Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities
* Active central nervous system disease involvement by malignancy or active CNS pathology
Primary outcome measure(s)
Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) — 24 months
Establish the RP2D of the investigational agent — 24 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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