Leukemia-Specific Immune Cells (BAFFR- CAR T Cells) for the Treatment of Relapsed or Refractory B-cell ALL

  • STATUS
    Recruiting
  • End date
    Apr 20, 2024
  • participants needed
    37
  • sponsor
    PeproMene Bio, Inc.
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Updated on 30 May 2022
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Summary

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Description

This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Acute Lymphoblastic Leukemia 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 B-cell Acute Lymphoblastic Leukemia
Treatment BAFFR-CAR T cells
Clinical Study IdentifierNCT04690595
SponsorPeproMene Bio, Inc.
Last Modified on30 May 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
Life expectancy ≥ 16 weeks
Relapsed/refractory disease after failure of ≥ 2 prior lines of therapy
Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma
Recovered to ≤ Grade 1 from the acute toxic effects (except alopecia) of prior anti-cancer therapy
Evidence of active BAFF-R expression at the time of enrollment
No known contraindications to leukapheresis, steroids or tocilizumab
For participants to be eligible for the trial following prior CD19-CAR T cell
Ineligible for or failed prior CD19-targeted immunotherapy (e.g., blinatumomab or CD19-CAR T cells)
therapy at least 90-days has elapsed since participant received last CD19-CAR
T cell therapy
Participants with CNS involvement by leukemia (CNS2 and asymptomatic CNS3) may be considered eligible after discussions with the study team
Total serum bilirubin ≤2.0 mg/dL (unless has Gilbert's disease or leukemia involvement of the liver, then ≤3.0)
AST ≤2.5 x ULN
ALT ≤ 2.5 x ULN
Creatinine clearance of ≥ 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula
Left ventricular ejection fraction (LVEF) ≥ 50%
O2 saturation ≥ 92% on room air
Seronegative for HIV Ag/Ab combo, HCV, and active HBV (Surface Antigen Negative)
If positive, Hepatitis C RNA quantitation must be performed and must be undetectable
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the
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
urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required
^Childbearing potential defined as not being surgically sterilized (men and
women) or have not been free from menses for > 1 year (women only)
A complete liver evaluation (which includes ultrasound elastography, MRI of the liver and a hepatology consult) may be done if needed based on PI's recommendation
Evaluation of acquired hemochromatosis (indicated through MRI of the liver and elevated levels of Ferritin) is recommended for participants who have undergone multiple transfusions and prior alloHCT

Exclusion Criteria

Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment
Auto-immune disease or active GVHD requiring systemic immunosuppressant therapy
Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification
Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within 2 weeks of enrollment
Subjects with a known 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
Immunosuppressant medications within 3 months prior to protocol enrollment
Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
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 (prednisone ≤ 7.5 mg /day or equivalent) is allowed
History of stroke or intracranial hemorrhage within 6 months of enrollment
Clinically significant uncontrolled illness
Active systemic uncontrolled infection requiring antibiotics
Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
Any abnormal liver enzyme levels (as defined ≥ULN in ALT, AST, Bilirubin and Alkaline Phosphatase levels) at time of enrollment
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the subject'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)
History of venous occlusive disease (VOD), or GvHD
Subjects with a history of the following GvHD may still be included in the study
Resolved Grade 2 or less steroid-sensitive acute skin GvHD ii. Grade 1 gastro-intestinal (GI)-GvHD developed within 100 days post prior alloHCT
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
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