CD45BE-HSPC + CART-45 Cells
Recruiting now · Phase 1
Conditions studied: B-Cell Non-Hodgkin Lymphoma (NHL), Richter's Transformation, T-Cell Non-Hodgkin Lymphoma, Hodgkin Lymphoma
In brief
This is a phase 1, open-label, dose-finding study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous base edited anti-CD45 CAR T cells (referred to as "CART-45 cells") following an autologous transplant of CD45 base edited hematopoietic stem and progenitor cells (referred to as "CD45BE-HSPC") in patients with relapsed or refractory hematologic malignancies.
Key facts
- Study ID
- NCT07451054
- Run by
- University of Pennsylvania
- People needed
- 42
- Starts
- 2026-08-05
- Expected to finish
- 2051-07-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent form 2. Male or females age ≥ 18 years 3. Disease-Specific Criteria
- a. B-cell Non-Hodgkin Lymphoma (B-cell NHL)- including the following sub-types:
- i. Patients with any of the following large B-cell lymphoma diagnoses who meet the prior treatment criteria outlined below: Diffuse Large B-cell Lymphoma not otherwise specified (DLBCL NOS); Primary Cutaneous DLBCL; Primary Mediastinal (thymic) Large B-cell Lymphoma; ALK+ Anaplastic Large B-cell Lymphoma; High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangements (i.e., "Double or Triple Hit"); High-grade B-cell Lymphoma, NOS; T-cell Rich B-cell Lymphoma; Transformed Follicular Lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma.
- Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND 2. Relapsed/refractory disease after at least 2 prior lines of appropriate therapy.
- ii. Follicular Lymphoma
- Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND
- Relapsed/refractory disease after at least 2 prior lines of systemic therapy (not including a single agent monoclonal antibody therapy).
- iii. Mantle Cell Lymphoma
- Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND
- Relapsed/refractory disease after at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (TKI) inhibitor. Single-agent monoclonal antibody therapy does not count towards prior lines of therapy.
- iv. Marginal Zone Lymphoma- relapsed/refractory disease after at least 2 prior lines of appropriate therapy, including a Bruton tyrosine kinase (TKI) inhibitor. Note: Single-agent monoclonal antibody therapy does not count towards prior lines of therapy.
- b. T-cell Non-Hodgkin Lymphoma (T-cell NHL)
- i. Histologically or cytologically confirmed relapsed or refractory (r/r) mature aggressive T- and NK-cell neoplasms as defined in the 5th edition of the WHO Classification of Hematolymphoid tumors, which includes any of the following diagnoses:
- Peripheral T-cell Lymphoma, NOS (PTCL-NOS);
- Nodal T-cell Lymphomas with T Follicular Helper [TFH] Phenotype, including Follicular T cell Lymphoma, Angioimmunoblastic Lymphoma, or Anaplastic Large Cell Lymphoma (ALCL);
- ALK+ or ALK-, Enteropathy-Associated T-cell Lymphoma (EATL);
- Monomorphic Epitheliotropic Intestinal T-cell Lymphoma (MEITL);
- Extranodal NK/T-cell Lymphoma;
- Primary Cutaneous T-cell Lymphoma (CTCL);
- Transformed Mycosis Fungoides (tMF) without blood involvement;
- Primary Cutaneous Aggressive Epidermotropic CD8+ Cytotoxic T-Cell Lymphoma;
- Subcutaneous Panniculitis-like T-cell Lymphoma.
- ii. Must have received at least one prior line of systemic therapy for their lymphoma. Additional prior treatment provisions required for the following indications:
- Participants with Anaplastic Large Cell Lymphoma (ALCL) must have received prior Brentuximab vedotin, unless contraindicated.
- Participants with Subcutaneous Panniculitis-like T-cell Lymphoma or Transformed Mycosis Fungoides (tMF) must have received at least 2 prior lines of systemic therapy.
You may not qualify if…
- Active hepatitis B or hepatitis C infection
- Any active, uncontrolled infection.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
- Severe, active co-morbidity that, in the opinion of the physician-investigator, would preclude participation in this study.
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Active acute or chronic GVHD requiring systemic therapy.
- Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications.
- Active CNS involvement. Patients with a history of CNS involvement that was successfully treated are eligible. A CNS evaluation is only required for eligibility if a subject is experiencing signs/symptoms of CNS involvement.
- Patients with evidence of a circulating T-cell malignancy as measured by flow cytometry.
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
- Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods.
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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