Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04892277

CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies

Led by Mayo Clinic · Updated on 2025-07-01

25

Participants Needed

1

Research Sites

912 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.

CONDITIONS

Official Title

CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of relapsed or refractory CD19-positive B cell malignancies including non-Hodgkin lymphoma, Richter Transformation of CLL, chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL)
  • Two or more prior treatments including an anthracycline-containing regimen unless intolerable (exceptions apply for Richter transformation and ibrutinib resistance)
  • Progressive or stable disease by PET/CT or CT following most recent chemotherapy
  • Measurable disease with at least one lesion over 1.5 cm or elevated lymphocyte count in CLL/SLL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Hemoglobin level 8.0 g/dL or higher within 14 days prior to registration
  • Absolute neutrophil count of 500/mm3 or higher within 14 days prior to registration
  • Platelet count of 30,000/mm3 or higher within 14 days prior to registration
  • Total bilirubin 2.0 mg/dL or lower (exceptions for Gilbert's syndrome) within 14 days prior to registration
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) levels 3 times upper limit of normal or lower within 14 days prior to registration
  • Prothrombin time (PT)/INR and aPTT 1.5 times upper limit of normal or lower or within target range if on anticoagulants within 14 days prior to registration
  • Creatinine clearance of 45 ml/min or higher within 14 days prior to registration
  • Cardiac ejection fraction 50% or higher with no significant pericardial effusion
  • Baseline oxygen saturation of 92% or higher on room air
  • Negative pregnancy test within 7 days prior to registration for persons of childbearing potential
  • Women of childbearing potential agree to use two highly effective forms of birth control during the study and for 12 months after treatment
  • Provide written informed consent
  • Willing to provide mandatory blood samples for research
  • Willing to return for follow-up visits during active monitoring phase
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons or women unwilling to use highly effective contraception
  • Sexually active males unwilling to use contraception during the study and for 12 months after treatment
  • Patients able to access approved CD19 CAR T-cell therapies
  • Live vaccine within 6 weeks prior to registration
  • Autologous stem cell transplant within 6 weeks prior to registration
  • Allogeneic stem cell transplant less than 100 days prior, active graft-versus-host disease, or on chronic immunosuppression
  • History of seizure disorder, stroke, dementia, cerebellar disease, or autoimmune diseases with CNS involvement
  • Primary immunodeficiency such as severe combined immunodeficiency
  • Need for systemic corticosteroids over 20 mg/day prednisone or equivalent
  • History of severe allergic reaction to CAR-T therapy components or stem cell infusion ingredients
  • History of other cancers unless disease-free for 2 years (exceptions apply)
  • Active infections requiring IV antibiotics or recent IV antibiotics within 7 days
  • Known HIV, active or chronic hepatitis B or C unless cleared
  • Recent significant cardiovascular events or conditions within 6 months
  • Any other medical or psychiatric condition that increases risk or makes participation inappropriate
  • Concurrent cancer therapy except under specified washout or timing conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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