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An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia

NCT07324889 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-08

No results posted yet for this study

Summary

This study is an open-label, single-arm, prospective, multicenter, phase I/II clinical trial. It adopts the two-stage optimal design proposed by Bryant and Day to investigate the efficacy, safety, and in vivo pharmacokinetic characteristics of CD19/BCMA CAR-T cell therapy in the treatment of relapsed/refractory warm antibody autoimmune hemolytic anemia.

Conditions

  • Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia

Interventions

DRUG

CD19/BCMA CAR-T

Eligible participants should receive preconditioning 5 to 3 days before CAR-T cell infusion. The recommended preconditioning regimen is fludarabine (30 mg/m²/day for 3 consecutive days) and cyclophosphamide (300 mg/m²/day for 3 consecutive days) (Flu/Cy). Thirty minutes before infusion, medications for preventing allergic reactions should be administered: 25 mg of promethazine hydrochloride or 12.5 mg of diphenhydramine, which can be given intramuscularly or orally. Adopting the two-stage optimal design proposed by Bryant and Day, it is planned to enroll 24 subjects with relapsed/refractory warm antibody autoimmune hemolytic anemia, with a selected dosage of 1×10⁶ CAR⁺ cells/kg.

Sponsors & Collaborators

  • Yihao Wang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07324889 on ClinicalTrials.gov