40 Participants Needed

Obecabtagene Autoleucel for Acute Lymphoblastic Leukemia

Recruiting at 6 trial locations
JP
Overseen ByJae Park, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).

Who Is on the Research Team?

JP

Jae Park, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 40 and above with B-cell acute lymphoblastic leukemia (ALL) in complete remission but still at high risk. It includes those who've had specific prior treatments like Inotuzumab or blinatumomab, and are now MRD-negative. Younger patients (30-39) with high-risk health issues may also qualify.

Inclusion Criteria

I have been diagnosed with CD19+ B-cell ALL.
My cancer is in remission with no minimal residual disease detected.
My leukemia is either Ph-positive or Ph-negative.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive obe-cel infusion for treatment of B-cell acute lymphoblastic leukemia

1 day (infusion)
1 visit (in-person)

Follow-up

Participants are monitored for relapse free survival and event free survival

1 year
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Obecabtagene Autoleucel

Trial Overview

The study tests obecabtagene autoleucel (obe-cel), a new therapy for B-cell ALL that's in remission without detectable cancer cells. Participants must have responded to past treatment and be within four months of their initial anti-leukemic therapy when joining the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment1 Intervention
Group II: Cohort AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Autolus Limited

Industry Sponsor

Trials
9
Recruited
1,000+