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New treatment option for B-Cell Non-Hodgkin Lymphoma (NHL)
Official title CD45BE-HSPC + CART-45 Cells
ClinicalTrials.gov ID: NCT07451054
What this study is testing
What is CART-45 cells?
CART-45 cells is an investigational medicine, being studied as a potential treatment for b-cell non-hodgkin lymphoma (nhl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Signed informed consent form 2. Male or females age ≥ 18 years 3. Disease-Specific Criteria a. B-cell Non-Hodgkin Lymphoma (B-cell NHL)-...
- 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...
- 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...
You likely can't join 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...
- 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 how well it works assessment of...
See the full eligibility criteria
Who can join
- 1\. 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...
- 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...
- 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: 1\...
- Brentuximab vedotin and immune checkpoint inhibitors (unless contraindicated); AND
- Autologous stem cell transplant (unless patient has chemorefractory disease to salvage treatment) d. Large Cell Transformation of CLL (Richter's Transformation) i. Patients must be primary refractory or received at...
- Serum creatinine ≤ 1.5x ULN or estimated creatinine clearance ≥ 35 mL/min and not on dialysis
- ALT/AST ≤ 3 x ULN
- Direct bilirubin ≤ 2.0 mg/dl; for patients with Gilbert's syndrome direct bilirubin must be ≤ 3.0 mg/dl
- Left Ventricular Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
- DLCO \> 45% predicted value; adjusted for level of hemoglobin
- Must have minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air 7. ECOG Performance Status 0-1
What rules you out
- 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 how well it works 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.