CAR T-Cell Therapy for Leukemia and Lymphoma

Overseen by Margaret Lamb, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Nationwide Children's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma. Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.

Research Team

Margaret Lamb, MD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for children and young adults up to age 30 with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants must have a certain level of heart, liver, kidney, and lung function, agree to use contraception if applicable, and not be pregnant. They can't join if they have HIV/AIDS, uncontrolled infections including hepatitis B/C, recent graft versus host disease after a transplant, any prior CD19 CAR T cell therapy or are part of another investigational study within the last month.

Inclusion Criteria

I was diagnosed with my condition before turning 31.

My child has B-Cell ALL that has not responded to treatment.

My parent or guardian has signed the consent form for me.

Exclusion Criteria

I have no major ongoing nerve-related issues except for controlled seizures or stable conditions.

I do not have active hepatitis B or C, nor any uncontrolled infections.

HIV positive test within 8 weeks of screening

Treatment Details

Interventions

• CD19 specific Chimeric Antigen Receptor T Cell (CAR T-cell Therapy)

Trial Overview The trial tests anti-CD19 CAR T cells made on-site for safety and effectiveness against specific blood cancers. It involves screening patients followed by chemotherapy to prepare their bodies before infusing these engineered immune cells. The process includes collecting patient's cells (leukapheresis), giving chemo drugs fludarabine/cyclophosphamide over four days then infusing the CAR T cells between day 2-14 post-chemo.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Leukopharesis: cells collected with a target of ≥1 x10\^9 TNC with ≥3% CD3+ cells. Lymphodepleting chemotherapy: 4 days of IV chemotherapy with fludarabine and cyclophosphamide. * Fludarabine 30 mg/m2/day IV x 4 days (days -6 through -3) * Cyclophosphamide 500 mg/m2/day IV x 2 days (days -6 and-5) anti-CD19 CAR T cells: * 0.3 - 1 x 10\^6 per kilogram for patients \<50 kg * Flat dose of 0.3 - 1 x 10\^8 for patients ≥50 kg The cell infusion will take place on day 0 (at least 2 days after completion of lymphodepleting chemotherapy). The patient will receive pre-medication with acetaminophen and diphenhydramine 30-60 minutes prior to the cell infusion.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University