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

  • STATUS
    Recruiting
  • End date
    Jun 13, 2026
  • participants needed
    18
  • sponsor
    PeproMene Bio, Inc.
Updated on 7 October 2022

Summary

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Description

This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with Mantle Cell Lymphoma (MCL) that has come back (recurrent) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize BAFFR, a protein on the surface of cancer cells. These BAFFR-specific T cells may help the body's immune system identify and kill BAFFR+ cancer cells

Details
Condition Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Treatment BAFFR-CAR T cells
Clinical Study IdentifierNCT05370430
SponsorPeproMene Bio, Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Documented informed consent of the participant and/or legally authorized representative
\. Agreement to allow the use of archival tissue from diagnostic tumor biopsies If unavailable, exceptions may be granted with Study PI approval
\. Age: ≥ 18 years
\. ECOG ≤ 2
\. Histologically confirmed Mantle Cell Lymphoma (MCL)
Evidence of positive BAFF-R expression on the MCL cells at the time of enrollment is required. Archival tissue is allowed if there is a significant safety risk for a repeat biopsy or if the lymphoma site is not accessible
Subjects with other relapsed or refractory BAFFR+ B cell lymphoma with no standard of care options are allowed during initial dose escalation phase, not the dose expansion phase
\. Relapsed/refractory disease after failure of at least 1 prior regimen
Participants who have primary refractory MCL (with or without prior BTK inhibitor) defined as lymphoma did not respond to a first line therapy or the response did not last longer than 6 months from an initial response, or
Participants who have relapsed MCL defined as recurrence of disease after an initial response lasting longer than 6 months, must have had at least 1 prior regimen that must include a BTK inhibitor, or
Participants with newly diagnosed MCL without standard of care (SOC) options (e.g., TP53 mutation, ineligible for intensive chemotherapy) are eligible after discussion with PI
\. Measurable disease by CT scan (≥1.5 cm) or evidence of blood, gastrointestinal
skin, bone marrow or spleen involvement
\. Prior CAR T cell therapy is allowed if at least 90 days prior to leukapheresis procedure
\. Fully recovered from the acute toxic effects (except alopecia) to ≤ Grade 1 to prior anti-cancer therapy
\. No known contraindications to leukapheresis, steroids or tocilizumab
\. Total bilirubin ≤ 1.5 X ULN (unless has Gilbert's disease), then ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN)
\. AST < 3 x ULN
\. ALT < 3 x ULN
\. Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula
\. Left ventricular ejection fraction (LVEF) ≥ 45% Note: To be performed within 28 days prior to start of protocol therapy
\. QTc ≤ 480 ms Note: To be performed within 28 days prior to start of protocol therapy
\. O2 saturation > 91% on room air
\. Seronegative for HIV Ag/Ab combo, HCV, active HBV (Surface Antigen Negative)
If seropositive for HIV, HCV or HBV (surface antigen or core antibody positive), nucleic acid quantitation must be performed. Viral load must be undetectable
\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
will be required
__20. Agreement by females and males of childbearing potential to use an effective method
of birth control or abstain from heterosexual activity for the course of the study through
at least 3 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have
not been free from menses for > 1 year (women only)

Exclusion Criteria

Prior allogeneic stem cell transplant
Autologous stem cell transplant within 90 days at the time of enrollment
Concurrent use of systemic steroids or chronic use of immunosuppressant
medications. Recent or current use of inhaled steroids is not exclusionary
Physiologic replacement of steroids (i.e., prednisone ≤ 7.5 mg/day or hydrocortisone ≤
mg/day) is allowed. During study participation, participants may receive systemic
corticosteroids as needed for treatment-emergent comorbid conditions
Cardiac lymphoma involvement
Requirement for urgent therapy due to tumor mass effects such as bowel obstruction
or blood vessel compression
Auto-immune disease or condition requiring systemic immunosuppressant therapy
including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic
thrombocytopenic purpura (ITP)
Primary immunodeficiency
Class III/IV cardiovascular disability according to the New York Heart Association
(NYHA) Classification
History of clinically significant arrhythmia. Paroxysmal atrial fibrillation or
flutter that is stable on medical management at least 2 weeks prior to enrollment is
allowed
History or prior diagnosis of optic neuritis or other immunologic or inflammatory
disease affecting the central nervous system, including seizure disorder
History of allergic reactions attributed to compounds of similar chemical or
biologic composition to study agent, including lymphodepletion agents and tocilizumab
History of stroke or intracranial hemorrhage within 6 months of enrollment
History of venous thrombotic embolism (VTE) within 6 months of enrollment with
exception of central line associated VTE
History of other malignancies, except for malignancy surgically resected (or
treated with other modalities) with curative intent, basal cell carcinoma of the skin
or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer
malignancy treated with curative intent with no known active disease present for ≥ 3
years
Clinically significant uncontrolled illness
Active systemic uncontrolled infection requiring antimicrobials
Active CNS MCL or History of CNS MCL within 3 months prior to screening
Females only: Pregnant or breastfeeding i. Any other condition that would, in the
Investigator's judgment, contraindicate the patient's participation in the clinical
study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able
to comply with all study procedures (including compliance issues related to
feasibility/logistics)
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