Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05370430

BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL

Led by PeproMene Bio, Inc. · Updated on 2025-11-20

36

Participants Needed

6

Research Sites

313 weeks

Total Duration

On this page

Sponsors

P

PeproMene Bio, Inc.

Lead Sponsor

C

City of Hope Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

CONDITIONS

Official Title

BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by the participant or legally authorized representative
  • Age 18 years or older
  • ECOG performance status of 2 or less
  • Histologically confirmed B-cell Non-Hodgkin's Lymphoma including LBCL, MCL, and FL/MZL subtypes with prior treatment conditions
  • BAFFR expression present on lymphoma cells
  • Measurable disease with tumor size 1.5 cm or larger on imaging or disease evidence in blood, bone marrow, gastrointestinal tract, skin, or spleen
  • Prior CAR T-cell therapy allowed if at least 3 months since last treatment and CD19 CAR-T cells are less than 5% before leukapheresis
  • Adequate organ function including specified blood counts, liver and kidney function, heart and lung function
  • Negative for HIV, active hepatitis B or C infection (or undetectable viral load if positive)
  • Negative pregnancy test for females of childbearing potential
  • Use of effective contraception or abstinence through 3 months after treatment
Not Eligible

You will not qualify if you...

  • Prior allogeneic stem cell transplant
  • Autologous stem cell transplant within 6 months before leukapheresis
  • Concurrent use of systemic steroids or chronic immunosuppressants
  • Cardiac lymphoma involvement
  • Need for urgent therapy due to tumor-related complications such as bowel obstruction
  • Active autoimmune disease requiring immunosuppressants
  • Primary immunodeficiency
  • Significant cardiac conditions including severe heart failure, arrhythmia, recent heart attack or stroke within 6 months, or severe blood clots
  • Neurologic conditions such as prior optic neuritis, central nervous system inflammatory diseases, or seizure disorders
  • History of other malignancies unless removed or treated with curative intent and in remission for 3 years or more
  • Uncontrolled infections or active central nervous system lymphoma
  • Females who are pregnant or breastfeeding
  • Investigator-determined safety concerns or potential noncompliance with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

2

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

3

University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Actively Recruiting

4

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

5

Atrium Health Levine Cancer Institute - Morehead

Charlotte, North Carolina, United States, 28204

Actively Recruiting

6

Providence Swedish Cancer Institute

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

H

Hazel (Ting-Ying) Cheng, PhD

CONTACT

D

DeShaun Noakes, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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