CD19/BAFF-R in Vivo CAR-T Cell Therapy Targeting Relapsed/Refractory B Cell Acute Leukemia/Malignant Lymphoma

Sponsor
Qi deng
Study ID
NCT07383233
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Acute Leukemia
  • CAR T Cell Therapy
  • Lymphoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19/BAFF-R in vivo CAR-T cell intravenous infusion — BIOLOGICAL
    CD19/BAFF-R in vivo CAR-T cell intravenous infusion

Study Details

The currently CAR-T cell therapy in clinical practice largely depends on the expansion of CAR-T cells in vivo. However, the in vitro preparation process of CAR-T cells is complex and costly. In vivo CAR-T cell therapy eliminates the need for ex vivo preparation, significantly reducing treatment costs and procedural complexity. It enables immediate use, thereby improving patient accessibility. CD19 is stably overexpressed in more than 90% of B-cell malignancies. BAFF plays a core regulatory role in the survival, maturation, and homeostasis maintenance of B cells. BAFF-R is selectively expressed on the surface of mature B cell subsets and most B-cell malignancies. Currently, BAFF-R-based CAR-T therapy is in preclinical and early clinical research stages, demonstrating promising therapeutic potential, particularly offering a novel treatment option for patients with CD19-negative or drug-resistant B-cell tumors. The use of CD19/BAFF-R in vivo CAR-T cells as a new anti-tumor therapy may provide a new research direction for the treatment of relapsed/refractory B-cell acute leukemia/malignant lymphoma.

Key Dates

First listed
Feb 3, 2026
Start date
Jun 1, 2026
Status verified
Jan 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD19/BAFF-R in vivo CAR-T cell therapy

Primary Outcome Measure

Evaluate the safety of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma [ Time Frame: up to one month after the CAR-T infusion ]

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