CAR-T Cell Therapy for Acute Lymphoblastic Leukemia

(CAR-20/19-T Trial)

Overseen by Julie-An Talano, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Medical College of Wisconsin

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.

Research Team

Julie-An Talano, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for people with B-cell ALL that's come back or hasn't responded to treatment, including those who've tried multiple therapies or had a stem cell transplant. Adults and kids over 1 year old can join if they have good organ function, no serious heart issues, and agree to use birth control. People with allergies to certain animal products, active infections like HIV or hepatitis, severe autoimmune diseases, recent other cancer treatments, or untreated brain involvement by leukemia can't participate.

Inclusion Criteria

Meet criteria for regarding fertility and contraception. Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.

I will retake the CD3+ T-cell count test if I receive chemotherapy or steroids before apheresis.

I am over 18 and can consent, or if under 18, I have a guardian who can.

Exclusion Criteria

I do not have any active cancer except for skin cancer or any cancer that has been in remission for over 5 years.

Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution.

My acute lymphoblastic leukemia is not worsening quickly.

Treatment Details

Interventions

• CAR-20/19-T cells (CAR T-cell Therapy)

Trial Overview The study tests different doses of CAR-20/19-T cells (a type of immunotherapy) in patients with relapsed/refractory B-cell ALL. It aims to see how safe and effective this therapy is when targeting two specific proteins on cancer cells using a special device for cell processing.

Participant Groups

Group I: Dose Expansion Phase Experimental Treatment 4 Interventions

The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. Subjects will receive one of three dose levels. The dose expansion arm will be updated with the appropriate dose in the future based on the escalation results.

Group II: 5 x 10^5 CAR-20/19-T cells/kg Experimental Treatment 1 Intervention

The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort.

Group III: 2.5 x10^6 CAR-20/19-T cells/kg Experimental Treatment 1 Intervention

The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort.

Group IV: 1 x10^6 CAR-20/19-T cells/kg Experimental Treatment 1 Intervention

The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Dr. Joseph E. Kerschner

Medical College of Wisconsin

Chief Medical Officer since 2011

MD, specific institution not identified

Dr. John R. Raymond, Sr.

Medical College of Wisconsin

Chief Executive Officer since 2010

MD from the Medical University of South Carolina

Children's Hospital and Health System Foundation, Wisconsin

Collaborator

Trials

56

Recruited

93,300+