OncoMatch

OncoMatch/Clinical Trials/NCT07066397

A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL

Is NCT07066397 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ARM011 and Fludarabine for acute lymphoblastic leukemia.

Phase 1RecruitingTriArm Therapeutics (Taiwan) LimitedNCT07066397Data as of May 2026

Treatment: ARM011 · Fludarabine · CyclophosphamideThis is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: standard treatment

Refractory to or relapsed after current standard treatment

Cannot have received: anti-CD19 therapy

Exception: blinatumomab

Prior anti-CD19 therapy (other than blinatumomab)

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ functions

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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