Obecabtagene Autoleucel for ALL

Overseen By Elias Jabbour, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called obecabtagene autoleucel (obe-cel) to determine its effectiveness in controlling high-risk B-cell acute lymphoblastic leukemia (ALL) after the first treatment phase. It targets patients in their first remission who exhibit specific high-risk features, such as certain genetic markers or signs of persistent disease. This trial suits individuals diagnosed with high-risk B-cell ALL who are in remission and have specific genetic markers or signs of ongoing leukemia. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Previous studies have shown that the treatment called obecabtagene autoleucel (obe-cel) is safe. Researchers tested it in adults with hard-to-treat B-cell acute lymphoblastic leukemia (ALL) and found that it rarely caused serious immune-related side effects. Most participants did not experience severe problems from the treatment.

Additionally, the FDA has approved obe-cel for treating adults with a type of ALL that recurred or did not respond to other treatments. This approval indicates that obe-cel has passed strict safety tests for that specific use. While this doesn't guarantee safety in every situation, it provides some confidence in its overall safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acute lymphoblastic leukemia (ALL), which typically include chemotherapy and radiation, Obecabtagene Autoleucel offers a novel approach by utilizing CAR-T cell therapy. This treatment is unique because it involves genetically modifying a patient's own T-cells to target and destroy cancer cells more effectively. Researchers are excited about this treatment because it has the potential to offer a more targeted attack on cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional therapies. Additionally, the personalized nature of this therapy represents a significant advancement in precision medicine for ALL patients.

What evidence suggests that obecabtagene autoleucel might be an effective treatment for high-risk B-cell ALL?

Research shows that obecabtagene autoleucel, or obe-cel, holds promise for treating B-cell acute lymphoblastic leukemia (ALL). In this trial, participants will receive treatment with obe-cel. Studies have found that obe-cel leads to over 70% of patients with relapsed or hard-to-treat B-ALL experiencing a complete response, meaning their cancer greatly reduces or disappears. Specifically, over an average follow-up of 21.5 months, patients had an average event-free survival (EFS) of 11.9 months, which measures how long they live without their cancer worsening. Importantly, obe-cel carries a low risk of serious side effects like cytokine release syndrome. These findings suggest that obe-cel could be an effective option for managing high-risk B-cell ALL after initial treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Elias Jabbour, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with newly diagnosed, high-risk B-cell Acute Lymphoblastic Leukemia in first remission and less than 5% bone marrow blasts. Participants must have a performance status of 0-2, be CD19 positive, have controlled CNS or extramedullary leukemia, and adequate organ function. Those with hepatitis B/C, HIV, pregnancy/lactation or unwilling to consent are excluded.

Inclusion Criteria

I can take care of myself but may not be able to do heavy physical work.

My cancer cells test positive for CD19.

My leukemia outside the bone marrow is under control.

Exclusion Criteria

Unable or unwilling to sign the consent form

I have a history of Hepatitis B, C, or HIV, even if it's under control.

Pregnant or lactating; WOCBP must have negative pregnancy test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cytoreductive Chemoimmunotherapy

Participants receive cytoreductive chemoimmunotherapy to reduce tumor burden before consolidation therapy

4-6 weeks

Consolidation Treatment

Participants receive Obecabtagene Autoleucel as consolidation therapy

18 months

Regular visits for CAR-T-cell expansion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Obecabtagene Autoleucel

Trial Overview The study tests obecabtagene autoleucel (obe-cel) as consolidation therapy for high-risk B-cell ALL after initial treatment success. Consolidation therapy aims to sustain remission by further reducing cancer cell counts.

How Is the Trial Designed?

Group I: Treatment with Obecabtagene Autoleucel Experimental Treatment 1 Intervention

Participants in morphological remission will be eligible in the present study, the dose of obe-cel will be as per the FELIX trial as follows:

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Autolus, Ltd

Collaborator

Citations

1. library.ehaweb.org library.ehaweb.org/eha/2025/eha2025-congress/4159191/bijal.d.shah.efficacy.and.safety.outcomes.of.obecabtagene.autoleucel.28obe-cel29.html?f=

EFFICACY AND SAFETY OUTCOMES OF OBECABTAGENE ... 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 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6576

Efficacy and safety outcomes of obecabtagene autoleucel ... Conclusions: Obe-cel treatment resulted in favorable ORR and EFS with low Grade ≥3 CRS/ICANS incidence in both age groups. These findings ...

3. ashpublications.org ashpublications.org/ashclinicalnews/news/8475/Obecabtagene-Autoleucel-Effective-Treatment-for

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 ...

4. onclive.com onclive.com/view/obe-cel-is-effective-irrespective-of-age-in-relapsed-refractory-b-all

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- ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40550480/

Obecabtagene autoleucel, a novel CD19-directed CAR T- ... Data from early-phase and pivotal trials, particularly the FELIX phase Ib/II study, are discussed in detail, highlighting efficacy outcomes such ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39602653/

Obecabtagene Autoleucel in Adults with B-Cell Acute ... Conclusions: Obe-cel resulted in a high incidence of durable response among adults with relapsed or refractory B-cell ALL, with a low incidence ...

7. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2406526

Obecabtagene Autoleucel in Adults with B-Cell Acute ... Obe-cel resulted in a high incidence of durable response among adults with relapsed or refractory B-cell ALL, with a low incidence of grade 3 or higher immune- ...

8. ema.europa.eu ema.europa.eu/en/documents/assessment-report/aucatzyl-epar-public-assessment-report_en.pdf

Aucatzyl, INN-obecabtagene autoleucel In order to further characterise the long-term efficacy and safety of Aucatzyl in adult patients with r/r acute lymphoblastic leukaemia (ALL) ...

9. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute

FDA approves obecabtagene autoleucel for adults ... FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia · Efficacy and Safety.