CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR)
Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Small Lymphocytic Lymphoma, Relapsed Adult ALL
About this trial
This is an interventional treatment trial for Refractory B-Cell Non-Hodgkin Lymphoma focused on measuring Gene Therapy, CAR T-cells, chimeric antigen receptor, B-Cell Malignancies, CD19
Eligibility Criteria
Treatment Inclusion Criteria:
- Diagnosis of CD19-positive B-cell lymphoma or leukemia (ALL or CLL).
The disease is:
Cohort A (non-ALL patients):
- Relapsed or refractory after two or more lines of therapy, including a CD20 antibody, if an indolent lymphoma.
- Relapsed or refractory after two or more lines of therapy, including ibrutinib and venetoclax, if CLL.
Relapsed or refractory after two or more lines of therapy, including a CD20 antibody and an anthracycline, and the patient is ineligible for autologous stem cell transplantation, if an aggressive or highly aggressive lymphoma.
- Ineligibility for autologous stem cell transplantation includes non-responsive disease after salvage therapy and failure to mobilize stem cells for transplant.
Cohort B (ALL patients)
a. Relapsed or refractory after two or more lines of therapy, if ALL.
- Measurable disease by current criteria (Lugano criteria for lymphomas, IWG criteria for CLL, and detectable disease for ALL).
- Age ≥ 3 and ≤75 years.
- Bilirubin < 2 times (3 times if Gilbert syndrome) upper limit of normal
- AST and ALT less than 5 times the upper limit of normal.
- Estimated GFR ≥ 50 mL/min.
- Pulse oximetry of ≥ 90% on room air
- Karnofsky or Lansky score of ≥ 70.
- Recovered from the acute toxic effects of all prior chemotherapy based on the enrolling physician's assessment (if some effects of chemotherapy are expected to last long term, patient is eligible if meeting other eligibility criteria).
- Life expectancy of greater than 12 weeks.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
Treatment Exclusion Criteria:
- Currently receiving any investigational agents or received any cellular therapies within the previous 6 weeks.
- History of hypersensitivity reactions to murine protein-containing products.
- History of grade 2 to 4 graft-versus-host disease (GVHD)
- Pregnant or lactating.
- Active infection with HIV or HTLV.
- Active infection with HBV or HCV.
- Uncontrolled active bacterial, fungal or other viral infection.
Sites / Locations
- Houston Methodist HospitalRecruiting
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
CD19.CAR-aNKT cells (cohort A, non-ALL)
CD19.CAR-aNKT cells (cohort B, ALL).
This cohort is for patients without refractory/relapsed B-cell NHL or leukemia (ALL). Three dose levels will be evaluated. Patients will also receive lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by the CD19.CAR-aNKT cell infusion.
This cohort is for patients with refractory/relapsed B-cell NHL or leukemia (ALL). Three dose levels will be evaluated. Patients will also receive lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by the CD19.CAR-aNKT cell infusion.