Overview

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

Status:
Not yet recruiting
Trial end date:
2023-08-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
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