A Phase 1/2 interventional study of Surovatamig in B-cell Acute Lymphoblastic Leukemia (B-ALL), sponsored by AstraZeneca. Recruiting at 83 sites in 13 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and efficacy of surovatamig (AZD0486) monotherapy in participants with R/R B ALL. The study will consist of 4 parts. Part A: monotherapy dose escalation in 3L+ B-ALL. Part B: dose optimization in 3L+ B-ALL. Part C: Dose expansion in 3L+ B-ALL. Part D: Dose optimization and efficacy expansion in R/R B-ALL (2L+)
This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of surovatamig (AZD0486) monotherapy in r/r B-ALL.
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
This study's planned enrollment of 255 is above the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria:
The above is a summary, other exclusion criteria details may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ascending dose level cohorts of surovatamig (AZD0486) in B-ALL participants aged 12 years and above.
Drug: Surovatamig
Up to 2 cohorts will be evaluated prior declared safe-doses and schedules in order to determine the recommended phase 2 dose (RP2D). Participants, aged 12 years and above, will receive surovatamig (AZD0486) IV infusions and will be randomized in a 1:1 ratio.
Drug: Surovatamig
Part C will consist of 1 cohort of participants aged 12 years and above, treated with the optimal dose selected in Part B and receive IV surovatamig (AZD0486) monotherapy.
Drug: Surovatamig
Part D will enroll participants aged 12 years and above with Ph(+) and Ph(-) B-ALL relapsed/refractory to ≥1 prior line of therapy. Participants will be randomized 1:1 to 2 dose levels of surovatamig IV.
Drug: Surovatamig
Investigational Product administered via intravenous infusion.
Also known as: AZD0486
Part A: Frequency of DLTs
DLTs are dose-limiting toxicities as defined in the study protocol
Time frame: Up to 28 days
Parts A & B: Safety Evaluation of AZD0486
Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in laboratory evaluations; QTc, and vital signs changes.
Time frame: From signing of informed consent through data cutoff, up to 57 months
Parts B & C: Rate of CR within 3 cycles
To evaluate the efficacy of surovatamig based on NCCN response criteria (in Part B and C).
Time frame: Up to three cycles of 28 days each
Part D: CR/CRh within 3 cycles
To evaluate the efficacy of surovatamig in Part D based on NCCN response criteria. CR/CRh is defined as a best response of CR/CRh within 3 cycles.
Time frame: Up to three cycles of 28 days each
Part A: Rate of CR within 3 cycles
the percentage of participants with a best response of CR within 3 cycles based on NCCN response criteria by investigators
Time frame: Up to 3 cycles of 28 days each
Part A,B,C: Rate of CR/CRh and CR/CRh/CRi within 3 cycles
proportion of participants achieving CR/CRh/CRi within 3 cycles based on NCCN response criteria by investigators (Part A) based on the response evaluable population, and by central review confirmation (Parts B and C) based on the FAS.
Time frame: Up to 3 cycles of 28 days each
Parts A, B, C, D: Rate of CR, CR/CRh and CR/CRh/CRi at any time during the study
Rate of CR, CR/CRh and CR/CRh/CRi at any time during study (Best CR, best CR/CRh and best CR/CRh/CRi)
Time frame: From first dose to end of treatment or data cutoff, whichever comes first, assessed up to 57 months
Parts A, B, C, D: Duration of CR/CRh
the time from the date of first documented CR, CR/CRh, or CR/CRh/CRi response, respectively, until the date of documented relapse or death due to any cause in the absence of disease progression or relapse, whichever occurs earlier.
Time frame: From first dose to last progression or data cutoff, whichever comes first, assessed up to 57 months
Parts A, B, C, D: Event-free survival (EFS)
Event-free survival is defined as the time from the date of the first dose until the date of a relapse after achieving a CR, or death due to any cause, whichever occurs first.
Time frame: From First dose to last progression or data cutoff, whichever comes first, assessed up to 57 months
Parts A, B, C, D: Overall Survival (OS)
The OS is defined as the time from date of first dose until death due to any cause regardless of whether the participant withdraws from treatment or receives a TTNT.
Time frame: From First dose to data cutoff, up to 57 months
Parts B, C & D: Subsequent alloSCT or donor lymphocyte infusion if used as an alloSCT substitute
Percentage of participants who received a subsequent alloSCT, or DLI if used as an alloSCT substitute, post surovatamig treatment
Time frame: From first dose to EOT, up to 57 Months
Part A, B, C, D: MRD-negative rate of CR, CR/CRh and CR/CRh/CRi
To evaluate the impact of suravatomig on MRD-negative rate of CR, CR/CRh and CR/CRi
Time frame: From First dose to data cutoff, up to 57 months
Parts A, B, C, & D: PK characterization of suravatomig
Derived PK parameter: AUC
Time frame: From first dose to data cutoff, up to 57 months
A, B, C, & D: PK Characterization of suravatomig
Derived PK parameter: Cmax
Time frame: From first dose to data cutoff, up to 57 months
A, B, C, & D: PK Characterization of suravatomig
Derived PK Parameter: tmax
Time frame: From first dose to data cutoff, up to 57 months
A, B, C, & D: PK Characterization of suravatomig
Derived PK parameter: Ctrough
Time frame: From first dose to data cutoff, up to 57 months
A, B, C, & D: PK Characterization of suravatomig
Derived PK Parameter: t1/2
Time frame: From first dose to data cutoff, up to 57 months
A, B, C, & D: PK Characterization of surovatamig
Derived PK Parameter: CL of surovatamig
Time frame: From first dose to data cutoff, up to 57 months
Parts A, B, C, D: ADA characterization of suravatomig
Summary of pre-existing and treatment-induced ADAs for suravatomig (positive or negative, titres)
Time frame: From First dose to EOT, up to 57 months
Part C, D: Safety Evaluation of suravatomig
Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in laboratory evaluations; QTc, and vital signs changes.
Time frame: From signing of informed consent through completion of study treatment, an average of 6 months
Part D: Rate of CR and CR/CRh/CRi within 3 cycles
CR/CRh within 3 cycles based on NCCN response criteria by BM central review confirmation.
Time frame: Up to 3 cycles of 28 days each
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Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Surovatamig