Non Hodgkin Lymphoma Clinical Trial

Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma

Summary

This phase I/II trial studies the side effects and best dose of modified immune cells called CD19-CD22 chimeric antigen receptor (CAR) T cells in treating patients with CD19 positive(+), CD22+ B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T-cells are collected from the patient and genetic materials called "chimeric antigen receptors (CAR)" are transferred to the collected T-cells. The CAR T-cells are then infused back to the patient's body. Giving CD19- CD22 CAR T cells after chemotherapy may help to control the disease.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To determine the safety of infusion with chimeric antigen receptor T cells targeting CD19 and CD22.

II. To find the recommended phase II dose for recurrent/refractory CD19+CD22+ B cell malignancies.

SECONDARY OBJECTIVES:

I. To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19 and CD22.

II. To assess other response variables including minimal residual disease (MRD) negative remission, overall survival (OS), and event free survival (EFS).

EXPLORATORY OBJECTIVES:

I. To evaluate the immune reconstitution and persistence of CAR T cells for one year post infusion.

OUTLINE: This is a phase I, dose escalation study of autologous CD19/CD22 chimeric antigen receptor T-cells (CD19-CD22 CAR T cells) followed by a phase II study.

Patients receive standard of care cyclophosphamide intravenously (IV) over 30 minutes and fludarabine IV over 30 minutes on days -5, -4, and -3, and then receive CD19-CD22 CAR T cells IV on day 0. Patients with relapsed or persistent disease after a protocol assessment may receive a second infusion of CD19-CD22 CAR T cells.

After completion of study treatment, patients are followed up at 1, 2, 3, 6, and 12 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients with relapsed/refractory B-acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), or non-Hodgkin's lymphoma (NHL) treated with at least two lines of therapy, and have persistent or progressed disease including positive minimal residual disease (MRD)
Patients may have received last cytotoxic chemotherapy at least 3 weeks prior to lymphodepleting chemotherapy
Patient may continue targeted therapy until 2 weeks before initiation of lymphodepleting chemotherapy with the exception of ibrutinib
Disease must be CD19 and/or CD22 positive by flow cytometry or immunohistochemistry
Karnofsky/Lansky performance scale > 70
Total bilirubin less than < 1.5 mg/dL except patients with Gilbert syndrome whose total bilirubin must be < 3.0mg/dL
Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 X upper limit of normal (ULN)
Alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 5.0 ULN
Serum creatinine (as estimated by Cockcroft Gault) >= 60 cc/min
Cardiac ejection fraction >= 50% without evidence of pericardiac effusion as determined by echocardiogram (ECHO) or multigated acquisition scan (MUGA), no clinical significant electrocardiogram (ECG) findings
No clinical significant pleural effusion and baseline oxygen saturation >= 92%
Absolute lymphocyte count >= 100/ul
Be able to sign informed consent
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: birth control pills, patches, or injections, intrauterine device (IUD), diaphragm with spermicide, or condom with spermicide. Acceptable forms of birth control for male patients include condom with spermicide. If female participant becomes pregnant during the study, she will be taken off this study. If male participant fathers a child while on study, he must immediately notify his doctor

For patients with history of allogenic stem cell transplantation

Should not have active acute graft-versus-host disease (GVHD) grade >= 2
Should not be on immunosuppressants such as tacrolimus, sirolimus, cyclosporine, mycophenolates for a minimum of a month from CD19-CD22 CAR T cell infusion
Should not be on more than physiologic dose of systemic steroid for adrenal insufficiency (prednisone equivalent 5mg/day)
Transplantation should be more than 2 months from CD19-CD22 CAR T cell infusion
Other cell therapy including CAR T cells, donor lymphocyte infusion, virus specific T cells, natural killer (NK) cells, etc should have 6 weeks of wash-out period from the CD19-CD22 CAR T cell infusion
For patients with history of central nervous system (CNS) disease, CNS disease must be treated prior to enrollment
For patients with prior treatment history of cell therapy such as other CAR T cells or CAR NK cells or NK cells, cell therapy should have a 6 weeks of wash-out period from CD19-CD22 CAR T cell infusion
Be able to consent long-term follow-up protocol PA17-0483

Exclusion Criteria:

Positive beta-human chorionic gonadotropin (hCG) in female of child bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females
Known positive serology for human immunodeficiency virus (HIV)
Presence of active grade 3 or greater toxicity from the previous treatment
Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management
Presence of active neurologic disorders
Concomitant use of other investigational agents
Current use of corticosteroid more than physiological dose for adrenal insufficiency (prednisone equivalent at a dose higher than 10 mg/day)
Presence of active CNS disease

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT04029038

Recruitment Status:

Withdrawn

Sponsor:

M.D. Anderson Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

M D Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT04029038

Recruitment Status:

Withdrawn

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.