Status:
ACTIVE_NOT_RECRUITING
CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory B-Cell Small Lymphocytic Lymphoma
Eligibility:
All Genders
3-75 years
Phase:
PHASE1
Brief Summary
This study is for patients who have lymphoma or leukemia that has come back or has not gone away after treatment. Because there is no standard treatment for this cancer, patients are being asked to vo...
Detailed Description
Earlier, a healthy donor provided blood to make ANCHOR cells in the laboratory. These cells were grown and frozen for later use. To make the ANCHOR cells, the investigators took the donor blood and st...
Eligibility Criteria
Inclusion
- Treatment
- 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
- 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.
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2035
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03774654
Start Date
June 22 2020
End Date
February 28 2035
Last Update
July 1 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030