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CAR T-cell Therapy

BAFFR-targeting CAR T Cells for B-Cell Lymphoma

Phase 1
Recruiting
Led By Elizabeth Budde, MD
Research Sponsored by PeproMene Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: ≥ 18 years
ECOG ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study Summary

This trial is testing a new treatment for mantle cell lymphoma, which uses CAR T cells to target BAFFR.

Who is the study for?
Adults with B-cell Non-Hodgkin's Lymphoma that has returned or didn't respond to at least one treatment can join. They must be physically capable (ECOG ≤ 2), have a certain level of organ function, and not be pregnant or breastfeeding. People who've had other cancers recently, major heart issues, immune deficiencies, uncontrolled infections, CNS lymphoma involvement within the last 3 months, or are on steroids/immunosuppressants can't participate.Check my eligibility
What is being tested?
The trial is testing BAFFR-CAR T cells in patients whose B-NHL has come back or hasn't responded to treatments. It's an early-phase study to see how safe it is and what effects it has on this type of lymphoma. Participants will receive genetically modified T cells designed to target and kill cancer cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of CAR T cells like fever, fatigue, headache; possible changes in blood counts; and risks associated with gene therapy such as immune system reactions against normal tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of the day.
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My cancer can be seen on a CT scan or is affecting my blood, GI tract, skin, bones, or spleen.
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I have recovered from side effects of previous cancer treatments.
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My kidneys are working well, as shown by a test.
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My lymphoma cells show positive BAFF-R expression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum Tolerated Dose (MTD)
Secondary outcome measures
B Cell Quantification
Disease Response
Minimal Residual Disease (MRD)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells]Experimental Treatment1 Intervention
BAFFR-CAR T cells in participants with r/r B-NHL

Find a Location

Who is running the clinical trial?

PeproMene Bio, Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
City of Hope Medical CenterOTHER
561 Previous Clinical Trials
1,918,216 Total Patients Enrolled
Elizabeth Budde, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

BAFFR-CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05370430 — Phase 1
B-Cell Non-Hodgkin Lymphoma Research Study Groups: B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells]
B-Cell Non-Hodgkin Lymphoma Clinical Trial 2023: BAFFR-CAR T cells Highlights & Side Effects. Trial Name: NCT05370430 — Phase 1
BAFFR-CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370430 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enrolling volunteers for this experiment?

"Yes, the clinicaltrials.gov entry for this trial reveals that it is actively recruiting participants. The public listing went up on June 13th 2022 and was recently adjusted on October 18th 2022; they are seeking 18 patients from a single research site."

Answered by AI

Has the FDA sanctioned BAFFR-CAR T cells for clinical usage?

"The safety of BAFFR-CAR T cells is assumed to be a 1 since this clinical trial only recently began and data on efficacy and safety are limited."

Answered by AI

What is the participant capacity of this medical experiment?

"Affirmative. Based on the information provided by clinicaltrials.gov, this medical research is currently seeking participants. The trial was initially posted on June 13th 2022 and most recently updated October 18th 2022 for a total of 18 enrollees from one site."

Answered by AI

What results is the research team hoping to accomplish with this trial?

"The principal aim of this medical research, evaluated over a period spanning up to one year post-treatment, is the incidence of adverse events. The secondary outcomes encompass disease response as per Lugano Criteria, B cell quantification via flow cytometry and progression-free survival (PFS) estimated through Kaplan-Meier product limit method with log-log transformation for confidence interval analysis."

Answered by AI
~23 spots leftby Jul 2027