NCT05370430

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
26mo left

Started Jun 2022

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2022Jun 2028

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2028

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

5.1 years

First QC Date

May 6, 2022

Last Update Submit

November 17, 2025

Conditions

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Keywords

Relapsed or RefractoryMantle Cell LymphomaBAFFR-CAR T cellsB-cell Non-Hodgkin's LymphomaB-NHLBAFFRMCLLBCL

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events

    Assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B-cell Non-Hodgkin's Lymphoma (B-NHL) and it's subtypes. Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.

    Up to 1 year post treatment

  • Maximum Tolerated Dose (MTD)

    Determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BAFFR-CAR T cells. The highest dose with ≤ 1/6 participants with DLT will be considered the MTD.

    The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.

Secondary Outcomes (5)

  • Disease Response

    Up to 1 year post treatment

  • Minimal Residual Disease (MRD)

    Up to 1 year post treatment

  • B Cell Quantification

    Up to 1 year post treatment

  • Progression-free survival (PFS)

    From CAR T cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.

  • Overall Survival (OS)

    From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.

Study Arms (1)

B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells]

EXPERIMENTAL

BAFFR-CAR T cells in participants with r/r B-NHL

Biological: BAFFR-CAR T cells

Interventions

BAFFR-CAR T cellsBIOLOGICAL

First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL

B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells]

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent: Signed informed consent by the participant or legally authorized representative.
  • Age \& Performance Status:
  • Age ≥ 18 years
  • ECOG performance status ≤ 2
  • Diagnosis \& Disease Criteria:
  • Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions.
  • BAFF-R expression on lymphoma cells required.
  • Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
  • Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence \< 5% before leukapheresis.
  • Organ Function \& Laboratory Criteria:
  • Hematologic: ANC ≥ 1000/μL, Platelets ≥ 75,000/μL (exceptions for BM involvement).
  • Liver Function: Bilirubin ≤ 1.5x ULN (except Gilbert's), AST/ALT \< 3x ULN.
  • Renal Function: CrCl ≥ 50 mL/min.
  • Cardiac \& Pulmonary: LVEF ≥ 45%, QTcF ≤ 480 ms, O₂ saturation \> 91% on room air.
  • Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).
  • +3 more criteria

You may not qualify if:

  • Prior Therapies \& Transplants:
  • Prior allogeneic SCT.
  • Autologous SCT \< 6 months before leukapheresis.
  • Concurrent systemic steroids or chronic immunosuppressant use.
  • Cardiac lymphoma involvement.
  • Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).
  • Medical Conditions:
  • Active autoimmune disease requiring immunosuppressants.
  • Primary immunodeficiency.
  • Cardiac conditions, including NYHA Class III/IV heart disease, arrhythmia, recent MI (≤ 6 months), stroke (≤ 6 months), or significant VTE (≤ 6 months).
  • Neurologic conditions, including prior optic neuritis, CNS inflammatory diseases, or seizure disorders.
  • History of malignancy, unless resected/treated with curative intent or in remission for ≥ 3 years.
  • Uncontrolled systemic infections or active CNS lymphoma.
  • Pregnancy \& Breastfeeding: Females who are pregnant or nursing.
  • Other Considerations:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Atrium Health Levine Cancer Institute - Morehead

Charlotte, North Carolina, 28204, United States

RECRUITING

Providence Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (1)

  • Dong Z, Budde LE, Oh E, Szymura S, Anderson A, Del Real M, Cha SC, Forman SJ, Kwak LW, Wang X. Analysis of polyfunctionality for enhanced BAFF-R CAR T-cell therapy for hematologic malignancies. Blood Adv. 2024 Aug 13;8(15):4066-4076. doi: 10.1182/bloodadvances.2024013195.

    PMID: 38885481DERIVED

MeSH Terms

Conditions

RecurrenceLymphoma, B-CellLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Elizabeth Budde, MD

    City of Hope Medical Center

    STUDY CHAIR

Central Study Contacts

Hazel (Ting-Ying) Cheng, PhD

CONTACT

714-599-8077hazel.cheng@pepromenebio.com

DeShaun Noakes, M.S.

CONTACT

760-533-4023DeShaun.Noakes@pepromenebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

June 13, 2022

Primary Completion (Estimated)

July 13, 2027

Study Completion (Estimated)

June 13, 2028

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

US(6)