Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07166419

Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, and Chronic Lymphocytic Leukemia

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-15

24

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase I trial tests the safety, side effects and best dose of anti-CD19/20/22 chimeric antigen receptor (CAR) T cells (TriCAR19.20.22 T cells) and how well they work in treating patients with non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy 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, such as CD19, CD20 and CD22, 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 TriCAR19.20.22 T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory non-Hodgkin lymphoma, ALL and CLL.

CONDITIONS

Official Title

Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, and Chronic Lymphocytic Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Relapsed or refractory non-Hodgkin lymphoma with lesions  5 cm, indolent lymphomas, or chronic lymphocytic leukemia without Richter's transformation (Cohort A)
  • Lymphoid blast crisis from chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions > 5 cm and/or lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells (Cohort B)
  • Treated with at least two lines of therapy; prior CAR T therapy targeting CD19, CD20, or CD22 allowed if at least 30 days have passed and circulating CAR T cells are < 5%
  • Relapsed/refractory CLL after at least 2 prior therapies including BTK inhibitor and venetoclax
  • Relapsed/refractory acute B-lymphoblastic leukemia after at least 2 prior therapies; failed or ineligible for allogeneic stem cell transplant
  • Relapsed/refractory lymphoid blast crisis from chronic myeloid leukemia after at least 2 prior therapies; failed or ineligible for allogeneic stem cell transplant
  • Lymphoid malignancy positive for CD19 and/or CD20 and/or CD22 by biopsy or blood test
  • ECOG performance status of 0, 1, or 2
  • Total bilirubin  1.5 times institutional upper limit
  • AST  3 times institutional upper limit
  • ALT  3 times institutional upper limit
  • Creatinine clearance  50 ml/min
  • Pulmonary function with pulse oximetry  92% on room air
  • Cardiac function with left ventricular ejection fraction  40%
  • Absolute lymphocyte count  100/uL or CD3 count  100/uL if differential not done
  • Ability and willingness to sign informed consent
  • For women of childbearing potential: agreement to abstain or use effective contraception during and for 6 months after treatment
  • For men: agreement to abstain or use contraception and refrain from sperm donation during and for 6 months after treatment
Not Eligible

You will not qualify if you...

  • Autologous transplant within 6 weeks before planned CAR T infusion
  • Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months before planned CAR T infusion; must be off immunosuppressive agents
  • Live vaccines within 28 days before lymphodepleting chemotherapy
  • Active graft versus host disease
  • Active malignancy other than non-melanoma skin cancer or carcinoma in situ
  • Less than 28 days since prior investigational agent treatment before lymphocyte collection
  • HIV positive without effective anti-retroviral therapy and undetectable viral load within 6 months
  • Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, lung problems, psychiatric illness or social situations limiting compliance
  • Pregnant or breastfeeding women
  • Evidence of myelodysplasia or related cytogenetic abnormalities
  • Positive hepatitis B core antibody or surface antigen without prophylaxis or monitoring
  • History of significant central nervous system disorders such as epilepsy, seizures, paresis, aphasia, uncontrolled stroke, brain injuries, dementia, or Parkinson's disease
  • Autoimmune disease requiring immunosuppressive drugs within 6 months prior to study

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

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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