Overview

Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells for B Lymphoid Malignancies

Status:
Recruiting

Trial end date:
2022-06-01

Target enrollment:
0

Participant gender:
All

Summary

If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if giving genetically changed immune cells, called CAR-NK cells, after chemotherapy will improve the disease in stem cell transplant patients with relapsed (has returned) and/or refractory (has not responded to treatment) B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia. The safety of this treatment will also be studied. This is an investigational study. The making of and infusion of genetically changed NK cells and the drug AP1903 (if you receive it, explained below) are not FDA approved or commercially available for use in this type of disease. They are currently being used for research purposes only. The chemotherapy drugs in this study (fludarabine, cyclophosphamide, and mesna) are commercially available and FDA approved. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Bellicum Pharmaceuticals

Treatments:

Cyclophosphamide
Fludarabine
Fludarabine phosphate
Mesna
Vidarabine

Criteria

Inclusion Criteria:

1. Patients with history of CD 19 positive B-lymphoid malignancies (ALL, CLL, NHL) who
have received at least 2 lines of standard chemoimmunotherapy or targeted therapy and
have persistent disease.

2. Patients with ALL, CLL, NHL with relapsed disease following standard therapy or a stem
cell transplant.

3. Patients at least 3 weeks from last cytotoxic chemotherapy at the time of starting
lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or
other targeted therapies until at least two weeks prior to administration of
lymphodepleting chemotherapy.

4. Karnofsky/Lansky Performance Scale > 70.

5. Adequate organ function: a. Renal: Creatinine clearance (as estimated by Cockcroft
Gault) >/= 60 cc/min. b. Hepatic: ALT/AST liver metastases, Total bilirubin Syndrome in whom total bilirubin must be fraction >/= 50%, no evidence of pericardial effusion as determined by an ECHO or
MUGA, and no clinically significant ECG findings. d. Pulmonary: No clinically
significant pleural effusion, baseline oxygen saturation > 92% on room air.

6. Able to provide written informed consent.

7. 7-80 years of age.

8. 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:
hormonal birth control, intrauterine device, diaphragm with spermicide, condom with
spermicide, or abstinence, for the length of the study. If the participant is a female
and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If
the participant becomes pregnant during this study, she will be taken off this study.
Men who are able to have children must use effective birth control while on the study.
If the male participant fathers a child or suspects that he has fathered a child while
on the study, he must immediately notify his doctor.

9. Signed consent to long-term follow-up protocol PA17-0483.

Exclusion Criteria:

1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal
for 24 months or no previous surgical sterilization or lactating females.

2. Known positive serology for HIV.

3. Presence of Grade 3 or greater toxicity from the previous treatment.

4. Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials
for management. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted
if responding to active treatment.

5. Presence of active neurological disorder(s).

6. Concomitant use of other investigational agents.