A Phase 1/2 interventional study of Surovatamig and Prednisone (or equivalent) in Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma and Mantle-cell Lymphoma, sponsored by AstraZeneca. Recruiting at 66 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies
This is open-label, multi-center study to evaluate the safety and preliminary efficacy of surovatamig administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies.
This master study currently includes 3 substudies and each substudy focusing on a defined population:
Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic lymphoma (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US)
The study will have the following sequential periods:
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
This study's planned enrollment of 408 is above the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell 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.
Compared within Leukemia, Lymphocytic, Chronic, B-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia, B-Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Master Inclusion Criteria applicable to all substudies:
Substudy 1 Specific Inclusion Criteria:
Substudy 2 Specific Inclusion Criteria:
Substudy 3 Specific Inclusion Criteria:
Cohort 3A:
Cohort 3B:
Exclusion Criteria:
Master Exclusion Criteria applicable to all substudies:
Substudy 1 Specific Exclusion Criteria:
Substudy 3 Specific Exclusion Criteria:
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive surovatamig monotherapy as subcutaneous (SC) injection.
Drug: Surovatamig
Participants will receive surovatamig as SC injection. Participants will receive acalabrutinib tablet orally twice daily.
Drug: Surovatamig · Drug: Acalabrutinib
Participants will receive surovatamig monotherapy as intravenous (IV) infusion.
Drug: Surovatamig
Participants will receive surovatamig monotherapy as SC injection.
Drug: Surovatamig
Participants will receive surovatamig monotherapy as IV infusion.
Drug: Surovatamig
Participants will receive surovatamig as IV infusion with a 2SUD (double step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Drug: Surovatamig · Drug: Prednisone (or equivalent) · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Doxorubicin
Participants will receive surovatamig as IV infusion with a 3SUD (triple step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Drug: Surovatamig · Drug: Prednisone (or equivalent) · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Doxorubicin
Surovatamig will be administered as either SC injection or IV infusion.
Also known as: AZD0486, TNB-486
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
Rituximab will be administered as IV infusion as per standard of care.
Cyclophosphamide will be administered as IV infusion as per standard of care.
Vincristine will be administered as IV infusion as per standard of care.
Doxorubicin will be administered as IV infusion as per standard of care.
Acalabrutinib will be administered orally
Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Time frame: Up to 6 years 4 months
Number of Participants with Dose Limiting Toxicity (DLTs)
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Time frame: Up to 2 months
Overall Response Rate (ORR)
ORR is defined as percentage of participants achieving either a partial response (PR) or complete response (CR) based on response criteria for International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving either PR or CR based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
Time frame: Up to 6 years 4 months
Complete Response (CR) Rate
CR rate is defined as percentage of participants achieving CR as best response based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
Time frame: Up to 6 years 4 months
Duration of Response (DoR)
DoR is defined as time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator, relapse or death (substudy 1) and time from the date of first documented response until date of documented progression based on Lugano 2014 Response Criteria by investigator assessment, relapse or death (substudies 2 and 3).
Time frame: Up to 6 years 4 months
Maximum Observed Concentration (Cmax)
The PK (Cmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Area Under the Concentration-time Curve (AUC)
The PK (AUC) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Minimum Observed Concentration (Cmin)
The PK (Cmin) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Time to Reach Maximum Concentration (tmax)
The PK (tmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Trough Plasma Concentration (Ctrough)
The PK (Ctrough) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Half Life (t1/2) of surovatamig
The PK (t1/2) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Clearance (CL) of surovatamig
The PK (CL) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Number of Participants with Anti-drug Antibody (ADA) for surovatamig
The incidence of immunogenicity of SC surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via there quest portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for May 2030, 63 months after the start.
Of 50 industry-sponsored phase 1/2 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 51 and three quarters within 104. This study's planned 63 months is below that.
Counting every sponsor, half of 90 studies reached it within 78 months; a quarter within 51 and three quarters within 103.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 28, 2026: primary completion Jun 2029 → May 2030 and completion Jun 2029 → May 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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
Leukemia, Lymphocytic, Chronic, B-Cell →