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Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

NCT07335328 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-13

No results posted yet for this study

Summary

This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.

Conditions

  • B-cell Non Hodgkin Lymphoma

Interventions

BIOLOGICAL

1 X 10^6 cells/kg

Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.

BIOLOGICAL

2.5 X 10^6 cells/kg

Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.

BIOLOGICAL

Dose expansion: The maximum tolerated dose of CAR-T cells

Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Nirav Shah, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-01
Completion
2031-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07335328 on ClinicalTrials.gov