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?

This trial explores a new treatment called obecabtagene autoleucel (obe-cel) for individuals with B-cell acute lymphoblastic leukemia (ALL). The goal is to determine if this treatment is effective for those whose cancer is currently undetectable after previous treatment. The trial is open to individuals with B-cell ALL who have no detectable cancer cells and have achieved complete remission for the first time. Participants must have previously received treatment for B-cell ALL and meet specific health criteria. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

Yes, you will need to stop certain medications before participating in the trial. Steroids, systemic chemotherapy, tyrosine kinase inhibitors, blinatumomab, and inotuzumab must be discontinued for specific periods before certain procedures in the trial.

Is there any evidence suggesting that obecabtagene autoleucel is likely to be safe for humans?

Research has shown that obe-cel, a treatment for B-cell acute lymphoblastic leukemia (ALL), has undergone testing in previous studies. One study involved 100 patients with relapsed or hard-to-treat B-cell ALL who received this treatment. Many patients tolerated it well, though some experienced side effects, which is common with these treatments. However, the study indicated that patients generally managed the treatment without major problems.

Obe-cel is also approved by the FDA for other uses, suggesting it is safe for humans. While side effects can occur, the treatment's approval means it has met certain safety standards. Always consult a healthcare professional about potential risks and benefits before joining any clinical trial.12345

Why do researchers think this study treatment might be promising for acute lymphoblastic leukemia?

Unlike the standard chemotherapy and radiation treatments for acute lymphoblastic leukemia, Obecabtagene Autoleucel is a groundbreaking CAR T-cell therapy. This treatment uses the patient's own immune cells, which are modified to specifically target and destroy leukemia cells. Researchers are excited about its potential because it provides a more personalized approach, potentially leading to better outcomes with fewer side effects. Moreover, it offers a promising option for patients who have not responded well to conventional therapies.

What evidence suggests that obecabtagene autoleucel might be an effective treatment for acute lymphoblastic leukemia?

Research has shown that a treatment called obecabtagene autoleucel, or obe-cel, may help treat B-cell acute lymphoblastic leukemia (ALL). Studies found that obe-cel led to complete remission in about 78% of patients, meaning most had no signs of cancer after treatment. Additionally, over 70% of patients with relapsed or hard-to-treat B-ALL responded completely to the treatment. These findings suggest that obe-cel effectively eliminates cancer cells, even in challenging cases. In this trial, participants will enroll in either Cohort A, for Philadelphia chromosome-negative patients, or Cohort B, for Philadelphia chromosome-positive patients. Obe-cel also maintains a good balance of benefits and risks, indicating it can be a safe option for many patients.56789

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.
See 7 more

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+

Citations

Efficacy and safety outcomes of obecabtagene autoleucel ...

These findings indicate that obe-cel is effective and has a positive benefit/risk profile regardless of age, including in older adults with R/R ...

Use of Obecabtagene Autoleucel CAR T-Cell Therapy for B ...

The initial report in 2024 revealed a rate of complete remission or complete remission with incomplete hematologic recovery of 78%. This CD19- ...

Obe-Cel Is Effective Irrespective of Age in Relapsed/ ...

Obecabtagene autoleucel achieved over 70% complete response rates in relapsed/refractory B-ALL across age groups, with minimal residual disease- ...

Obecabtagene Autoleucel Effective Treatment for Adults with ...

Over a median follow-up of 21.5 months, the investigators calculated a median event-free survival (EFS) of 11.9 months. The six-month EFS was ...

EFFICACY AND SAFETY OUTCOMES OF ...

Treatment-related mortality within 3 months post obe-cel infusion was 0% in pts aged <55 years vs 4.2% in pts aged ≥55 years. CAR T-cell ...

Package Insert - AUCATZYL

The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received ...

Unmet Need | AUCATZYL® (obecabtagene autoleucel) HCP ...

The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received ...

S262: SAFETY AND EFFICACY OF OBECABTAGENE ... - PMC

Obe-cel is effective with high CR/CRi rates and ongoing CAR T persistence in the majority of responders. The trial has completed dosing of all patients in ...

9.

aucatzyl.com

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AUCATZYL® CAR T Therapy for Relapsed or Refractory ALL

AUCATZYL is a treatment for adults with acute lymphoblastic leukemia. It is used following disease progression while on or after other treatment.