Dr. Nirali N. Shah
Claim this profileNational Institutes of Health, Clinical Center
Studies Adult T-Cell Leukemia/Lymphoma
Studies Acute Myeloid Leukemia
12 reported clinical trials
16 drugs studied
Area of expertise
1Adult T-Cell Leukemia/Lymphoma
CD19 positive
CD33 positive
CD22 positive
2Acute Myeloid Leukemia
CD33 positive
CD123 positive
Affiliated Hospitals
Clinical Trials Nirali N. Shah is currently running
CAR T-Cell Therapy
for Acute Lymphoblastic Leukemia
Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....
Recruiting1 award Phase 1 & 2
NGS Monitoring
for Acute Lymphoblastic Leukemia
Background: Chimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy. However, for people who relapse after CART, it can be hard to achieve remission again. In patients where CART fails, stem cell transplant (HCT) can be used to prevent relapse and achieve cure. But HCT can cause serious side effects. Better testing is needed to distinguish people who can be cured with CART alone from people who may also need to have HCT. Objective: To see if the use of a series of blood and bone marrow tests at regular intervals can help monitor for B-ALL relapse after CART therapy. Eligibility: People aged 1 to 25 years with B-ALL who have had CART therapy within the past 42 days. They must never have had a blood stem cell transplant; they must also have no measurable blood cancer cells. Design: Participants will visit the clinic every 2 weeks starting 42 days after they receive CART therapy. Each visit will be about the same amount of time as a regular clinic visit. about 8 hours. Participants will have blood drawn for testing on each visit. Bone marrow biopsy/aspirate will be done during 4 of the visits at routine timepoints after CART. A needle will be inserted to draw a sample of tissue from inside the bone in the hip. A small amount of blood and tissue will be tested with ClonoSEQ and to evaluate for normal B-cells side by side with the standard tests. The combined testing may help determine whether participants are eligible for HCT and/or at risk of relapse after CART. Participants will be in the study for 2 years.
Recruiting1 award N/A
More about Nirali N. Shah
Clinical Trial Related8 years of experience running clinical trials · Led 12 trials as a Principal Investigator · 4 Active Clinical TrialsTreatments Nirali N. Shah has experience with
- Fludarabine
- VOR33
- CD33CART
- CD19/CD22 CAR T-Cells
- Cyclophosphamide
- CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells
Breakdown of trials Nirali N. Shah has run
Adult T-Cell Leukemia/Lymphoma
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myeloid Leukemia
Acute Myelogenous Leukemia
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