Genetically Engineered Cells (BAFFR-CAR T Cells) for the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoblastic Lymphoma
A Phase 1 Study to Evaluate BAFFR-Targeting CAR T Cells for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
3 other identifiers
interventional
16
1 country
2
Brief Summary
This phase I trial tests the safety and side effects of B-cell activating factor receptor (BAFFR) chimeric antigen receptor (CAR) T cells and how well they work in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell lymphoblastic lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy, such as BAFFR-CAR T cells, is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving BAFFR-CAR T cells may be safe, tolerable and/or effective in treating patients with relapsed or refractory B-cell ALL and B-cell lymphoblastic lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2027
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2026
CompletedFirst Posted
Study publicly available on registry
August 11, 2026
CompletedStudy Start
First participant enrolled
April 17, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2028
Study Completion
Last participant's last visit for all outcomes
July 26, 2028
August 11, 2026
August 1, 2026
1.3 years
August 6, 2026
August 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events
Will be graded using Common Terminology Criteria for Adverse Events version 5.0, American Society for Transplantation and Cellular Therapy Consensus Criteria on Cytokine Release Syndrome/Neurotoxicity, graft-versus-host disease (GVHD) criteria, and Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome identification and grading. Will be summarized by organ involved, severity, time of onset, and attribution.
Up to 28 days after chimeric antigen receptor (CAR) T cells
Dose-limiting toxicity
Will be described individually.
From the start of CAR T infusion up to 28 days
Secondary Outcomes (6)
Disease response rate
At 4 weeks
Minimal residual disease negative rate
At 4 weeks
Duration of B-cell aplasia
Up to 15 years
Severity of GVHD in recipients of prior allogeneic hematopoietic stem cell transplantation
Within 8 weeks after T cell infusion
Progression-free survival
From T cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years
- +1 more secondary outcomes
Study Arms (1)
Treatment (BAFFR-CAR T cells)
EXPERIMENTALPatients undergo leukapheresis and may receive bridging therapy per treating physician discretion. Patients then receive lymphodepletion therapy with cyclophosphamide IV and fludarabine IV on days -5 to -3 and BAFFR-CAR T cells IV over 10-15 minutes on day 0. Patients also undergo blood sample collection, bone marrow aspiration and biopsy, chest x-ray, and PET/CT or CT throughout the study. Additionally, patients may also undergo liver ultrasonographic elastography at screening at discretion of investigator and brain MRI or CT, CSF specimen collection, and ECHO or MUGA throughout the study.
Interventions
Given IV
Undergo blood and CSF specimen collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Receive bridging therapy
Undergo chest x-ray
Undergo CT or PET/CT
Given IV
Undergo ECHO
Undergo leukapheresis
Undergo brain MRI
Undergo MUGA
Undergo PET/CT
Undergo liver ultrasonographic elastography
Eligibility Criteria
You may qualify if:
- 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 principal investigator (PI) approval
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Life expectancy ≥ 16 weeks
- Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma
- Relapsed/refractory disease. Minimal residual disease (MRD) relapse is allowed
- Evidence of tumor expressing BAFF-R at any level either by flow or immunohistochemistry
- Recovered to ≤ grade 1 from the acute toxic effects (except alopecia and peripheral neuropathy) of prior anti-cancer therapy
- No known contraindications to leukapheresis, steroids or tocilizumab
- Ineligible for or failed prior CD19-targeted immunotherapy (e.g., blinatumomab or CD19-CAR T cells)
- For participants who had prior CD19-CAR T cell therapy:
- At least 90-days has elapsed since participant received last CD19-CAR T cell therapy AND
- Persistence of prior CD19-CAR T cells must be evaluated and found to be \< 5% prior to leukapheresis procedure
- +20 more criteria
You may not qualify if:
- Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment
- Immunosuppressant medications within 1 month prior to protocol enrollment
- Auto-immune disease or active graft-versus-host disease (GvHD) within 3 months prior to protocol enrollment 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
- Any abnormal liver enzyme levels (as defined by grade 1 elevation from ULN in ALT, AST, and bilirubin levels) at time of enrollment, unless they are abnormal due to liver involvement by leukemia per the treating physician's discretion
- Subjects with a known history or prior diagnosis of uncontrolled central nervous system (CNS) disorders such as optic neuritis or other immunologic or inflammatory disease affecting the CNS, including uncontrolled seizure disorder
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Known significant bleeding disorders (e.g., severe von Willebrand's disease) or hemophilia
- 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
- Grade 1 gastrointestinal (GI)-GvHD developed within 100 days post prior alloHCT
- Limited chronic GVHD
- History of stroke or intracranial hemorrhage within 6 months of enrollment
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
City of Hope Medical Center
Duarte, California, 91010, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ibrahim Aldoss
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2026
First Posted
August 11, 2026
Study Start (Estimated)
April 17, 2027
Primary Completion (Estimated)
July 26, 2028
Study Completion (Estimated)
July 26, 2028
Last Updated
August 11, 2026
Record last verified: 2026-08