Acute Lymphocytic Leukemia (ALL)Phase 2NCT07053059
Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)
A Phase 2 study testing Obecabtagene autoleucel in people with Acute Lymphocytic Leukemia (ALL), run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia (ALL)
- What is being tested?
- Obecabtagene autoleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 31 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age .18 years with high-risk B-cell ALL in first remission and <5% BM blasts with at least one high-risk feature defined as:
- Ph-negative B-cell ALL:
- KMT2A rearranged ALL
- Complex cytogenetics as per NCCN 2022
- Low-hypodiploidy/tetraploidy
- Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
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- TP53 mutation (variant allele fraction >2%)
- Persistent MRD by flow cytometry and/or NGS
- Ph-positive B-cell ALL:
- IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc.
- High WBC (>30 x 109/L) at initial presentation
- Persistent MRD by flow cytometry and/or NGS and/or PCR II. Performance status of 0, 1, or 2 III. Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal IV. Patients should be CD19 expression positive (>1%) before enrollment V. Patients with controlled CNS and/or other extramedullary leukemia will be eligible.
Who cannot join
- Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Patients with history of Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) infections, even if under control. (Patients with Hepatitis B core antibody positive alone will not be an exclusion factor if HBV DNA PCR is negative).
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Elias Jabbour, MD, 713-792-4764, ejabbour@mdanderson.org
Elias Jabbour, MD
About this study
The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment.
Read the detailed description
Primary Objectives To assess the Efficacy of Obecabtagene autoleucel [anti-CD19 autologous derived chimeric antigen receptor T-cell (CAR-T)] in terms of EFS in patients with newly diagnosed high-risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS
Secondary Objectives:
- 24-month overall survival (OS)
- For Ph-negative B-cell ALL: Rate of persistent MRD negativity by flow cytometry and NGS at 18 months
- For Ph-positive B-cell ALL: Rate of persistent MRD negativity by flow cytometry, NGS and BCR::ABL1 qPCR (CMR) at 18 months
- Achievement of BCR::ABL1 complete molecular response (CMR) in patients with Ph-positive ALL having persistent measurable disease at any level before obe-cel infusion
- Achievement of NGS MRD negativity amongst patients in CR and not MRD negative before obe-cel
- Time to initiation of next anti-leukemia therapy except HSCT when done in ongoing continued morphological response (patients who did not start next anti-leukemia therapy except HSCT will be censored at the last follow-up/death).
- Rates of HSCT in morphologic remission after obe-cel infusion
- Safety
Exploratory Objectives:
- CAR-T-cell expansion by digital droplet PCR (ddPCR) assay by a manufacturer designated central laboratory (CellCarta) on Days 7, 14, 21, 28, 3 months and then every 3 months up to 12 months post infusion. This will be a send-out test.
- B-cell aplasia (Days 0, 7, 14, 28, monthly up to 3 months and then every 3 months up to 24 months post infusion)
- Measurable residual disease (MRD) negativity by next-generation sequencing (NGS) (at 1 in 105-6 sensitivity) (PB on D14 and PB/BM: Day 28, and then Q3 months up to 24 months post infusion)
- Cytokine panel to study cytokine profile including IL1, IL6, IFNG, TNFalpha from infusion (Days 0, 1, 2, 4, 7, 10, 14, 28)
- Additional correlatives samples to address tumor samples and immune system factors will be collected at baseline, D28 and Q3 months from infusion. These include samples for bulk RNA sequencing of the tumor and germline and single cell RNA sequencing of CAR T-cells as also for assessing the methylation signatures of the CAR T-cells. risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS
- Conditions
- Acute Lymphocytic Leukemia (ALL)
- Being tested
- Obecabtagene autoleucel
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obecabtagene autoleucelDrug
given by Infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Obecabtagene Autoleucel | Experimental | 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: Receives: Drug: Obecabtagene autoleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start26 Aug 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic Leukemia (ALL)Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Autolus, Ltd
- Responsible party
- Sponsor
- Investigators
- Elias Jabbour, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053059
- Sponsor's protocol ID
- 2025-0580
- Other IDs
- NCI-2025-04660
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT07053059
- Acronym / sponsor ID
- 2025-0580
- Conditions
- Acute Lymphocytic Leukemia (ALL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Autolus, Ltd
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment.
Detailed description
Primary Objectives To assess the Efficacy of Obecabtagene autoleucel [anti-CD19 autologous derived chimeric antigen receptor T-cell (CAR-T)] in terms of EFS in patients with newly diagnosed high-risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS
Secondary Objectives:
- 24-month overall survival (OS)
- For Ph-negative B-cell ALL: Rate of persistent MRD negativity by flow cytometry and NGS at 18 months
- For Ph-positive B-cell ALL: Rate of persistent MRD negativity by flow cytometry, NGS and BCR::ABL1 qPCR (CMR) at 18 months
- Achievement of BCR::ABL1 complete molecular response (CMR) in patients with Ph-positive ALL having persistent measurable disease at any level before obe-cel infusion
- Achievement of NGS MRD negativity amongst patients in CR and not MRD negative before obe-cel
- Time to initiation of next anti-leukemia therapy except HSCT when done in ongoing continued morphological response (patients who did not start next anti-leukemia therapy except HSCT will be censored at the last follow-up/death).
- Rates of HSCT in morphologic remission after obe-cel infusion
- Safety
Exploratory Objectives:
- CAR-T-cell expansion by digital droplet PCR (ddPCR) assay by a manufacturer designated central laboratory (CellCarta) on Days 7, 14, 21, 28, 3 months and then every 3 months up to 12 months post infusion. This will be a send-out test.
- B-cell aplasia (Days 0, 7, 14, 28, monthly up to 3 months and then every 3 months up to 24 months post infusion)
- Measurable residual disease (MRD) negativity by next-generation sequencing (NGS) (at 1 in 105-6 sensitivity) (PB on D14 and PB/BM: Day 28, and then Q3 months up to 24 months post infusion)
- Cytokine panel to study cytokine profile including IL1, IL6, IFNG, TNFalpha from infusion (Days 0, 1, 2, 4, 7, 10, 14, 28)
- Additional correlatives samples to address tumor samples and immune system factors will be collected at baseline, D28 and Q3 months from infusion. These include samples for bulk RNA sequencing of the tumor and germline and single cell RNA sequencing of CAR T-cells as also for assessing the methylation signatures of the CAR T-cells. risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Obecabtagene Autoleucel | Experimental | Drug: Obecabtagene autoleucelParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients of age .18 years with high-risk B-cell ALL in first remission and <5% BM blasts with at least one high-risk feature defined as:
- Ph-negative B-cell ALL:
- Ph-positive B-cell ALL:
Key exclusion criteria (4 listed)
- Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Patients with history of Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) infections, even if under control. (Patients with Hepatitis B core antibody positive alone will not be an exclusion factor if HBV DNA PCR is negative).
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obecabtagene autoleucelgiven by Infusion | Drug | Treatment with Obecabtagene Autoleucel |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elias Jabbour, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obecabtagene autoleucel in people with Acute Lymphocytic Leukemia (ALL), run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elias Jabbour, MD ((713) 792-4764, ejabbour@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.