AzTrials
AzTrials

B-Cell Non-Hodgkin Lymphoma (NHL)Phase 1NCT07451054

CD45BE-HSPC + CART-45 Cells

A Phase 1 study testing CART-45 cells and CD45BE-HSPC in people with B-Cell Non-Hodgkin Lymphoma (NHL) and Richter's Transformation, run by University of Pennsylvania at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CART-45 cells and CD45BE-HSPC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
5 Aug 2026to Jul 2051
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Signed informed consent form 2. Male or females age ≥ 18 years 3. Disease-Specific Criteria
  • B-cell Non-Hodgkin Lymphoma (B-cell NHL)- including the following sub-types:
  • 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.
  • 1. 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.
  • Follicular Lymphoma
  • Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND
Show all 41Show fewer
  • Relapsed/refractory disease after at least 2 prior lines of systemic therapy (not including a single agent monoclonal antibody therapy).
  • 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.
  • 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.
  • T-cell Non-Hodgkin Lymphoma (T-cell NHL)
  • 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.
  • Must have received at least one prior line of systemic therapy for their lymphoma. Additional prior treatment provisions required for the following indications:
  • 1. Participants with Anaplastic Large Cell Lymphoma (ALCL) must have received prior Brentuximab vedotin, unless contraindicated.
  • 2. Participants with Subcutaneous Panniculitis-like T-cell Lymphoma or Transformed Mycosis Fungoides (tMF) must have received at least 2 prior lines of systemic therapy.
  • Hodgkin Lymphoma (HL)
  • Patients with histologically proven classical Hodgkin Lymphoma that is CD45 positive by IHC or flow cytometry by a CLIA certified laboratory; AND
  • Relapsed/refractory disease after at least 2 prior lines of therapy which must include the following:
  • 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 least 1 prior line of treatment for Richter's Transformation.
  • 4. Patients are appropriate candidates for autologous HSCT as per physician-investigator clinical discretion
  • 5. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:
  • Have no active GVHD and require no immunosuppression
  • Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility
  • 6. Adequate organ function defined as:
  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abramson Cancer Center Clinical Trials Service contact

215-349-8245

PMCancerResearch@Pennmedicine.upenn.edu

United States1 site, 1 recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Abramson Cancer Center Clinical Trials Service, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Study of Autologous Anti-CD45 CAR T Cells in Combination With CD45 Base Edited HSPCs in Patients With Relapsed or Refractory Hematologic Malignancies

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.

Being tested
CART-45 cells, CD45BE-HSPC
Medical subject headings
Lymphoma, B-Cell, Lymphoma, T-Cell, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CART-45 cellsBiological

    Autologous base edited anti-CD45 CAR T cells

  • CD45BE-HSPCBiological

    CD45 base edited hematopoietic stem and progenitor cells

Study groups in NCT07451054
Study groupRoleWhat they receive
Cohort A: B-cell Non-Hodgkin Lymphoma (B-cell NHL), Richter's Transformation (RT)ExperimentalNot described
Receives: Biological: CART-45 cells; Biological: CD45BE-HSPC
Cohort B: T-cell Non-Hodgkin Lymphoma (T-cell NHL), Hodgkin Lymphoma (HL)ExperimentalNot described
Receives: Biological: CART-45 cells; Biological: CD45BE-HSPC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events as assessed by CTCAE v6.0

    Type, frequency and severity of adverse events as assessed by CTCAE V6.0. Each disease-specific cohort will be analyzed separately.

    Measured: Up to 15 years post infusion

  2. Occurrence of dose-limiting toxicities (DLTs)

    Unacceptable toxicity as defined by the protocol. DLTs will be evaluated separately by each disease-specific cohort.

    Measured: 28 days post-CART-45 infusion

  3. Identification of the maximum tolerated dose (MTD)

    Selected based on an isotonic regression model. The MTD will be established separately by disease-specific cohort

    Measured: 28 days post-CART-45 infusion

  4. Identification of a recommended dose for expansion (RDE)

    Evaluated by Cohort/dose level using a multi-criteria decision analysis.

    Measured: 3 months post-CART-45 infusion

Secondary outcomes (11)

  1. Proportion of CD45BE-HSPC products that fail to meet the product release criteria

    Calculated based on the proportion of subjects with CD45BE-HSPC products that fail to meet the product release criteria, out of the number of subjects in whom manufacturing was attempted.

    Measured: 3 months

  2. Proportion of CART-45 products that fail to meet the product release criteria

    Calculated based on the proportion of subjects with CART-45 products that fail to meet the product release criteria, out of the number of subjects in whom manufacturing was attempted.

    Measured: 3 months

  3. Proportion of CD45BE-HSPC products that fail to meet the protocol-defined dose

    Calculated based on the proportion of subjects with CD45BE-HSPC products that fail to meet the assigned dose, out of the number of subjects in whom manufacturing was attempted.

    Measured: 3 months

  4. Proportion of CART-45 products that fail to meet the assigned dose.

    Calculated based on the proportion of subjects with CART-45 products that fail to meet the assigned dose, out of the number of subjects in whom manufacturing was attempted.

    Measured: 3 months

  5. Evaluate study feasibility

    Proportion of eligible patients who receive both investigational products as planned; by individual disease-specific cohort and in aggregate.

    Measured: 3 months

  6. Engraftment of CD45BE-HSPC

    Number of subjects with engraftment of CD45BE-HSPC.

    Measured: 28 days after treatment

  7. Overall survival (OS)

    Duration of time from CD45BE-HSPC infusion (Day 0) to the date of death, for any reason

    Measured: Up to 15 years after last CART-45 Cells administration

  8. Overall Response/Remission Rate (ORR)

    Proportion of subjects with CR or PR at Month 3 as compared to baseline.

    Measured: Up to 12 months following CART-45 administration

  9. Best Overall Response (BOR)

    Proportion of subjects with a best objective disease response of CR or PR recorded between Month 3 and the end of primary follow-up (Month 12); or start of new anticancer therapy, whichever comes first.

    Measured: Up to 12 months following CART-45 administration

  10. Duration of Response (DOR)

    Time from the date when the response criteria of CR or PR is first met (at or following Month 3), to the date of confirmed disease progression, death, or other censoring event as described below.

    Measured: Up to 12 months following CART-45 administration

  11. Progression-Free Survival (PFS)

    The duration of time from the CD45BE-HSPC transplant (Day 0) to the date of confirmed disease progression or death, whichever occurs first. Otherwise, PFS will be censored at the date of the last response assessment, date of new anti-cancer treatment is initiated (including CART-45 retreatment) or the data cut-off date; whichever occurs first.

    Measured: Up to 15 years after product administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start5 Aug 2026
  3. Primary completionJul 2051 (estimated)
  4. Study completionJul 2051 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451054
Sponsor's protocol ID
50425
Status last verified
Aug 2026
First submitted
27 Feb 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CART-45 cells and CD45BE-HSPC in people with B-Cell Non-Hodgkin Lymphoma (NHL) and Richter's Transformation, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abramson Cancer Center Clinical Trials Service (215-349-8245, PMCancerResearch@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events as assessed by CTCAE v6.0 (time frame: Up to 15 years post infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07451054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in