ClinicalTrials.gg
RecruitingNCT06029309ZANU-TAFAUpdated Sep 21, 2026

Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma

A Phase 1/2 interventional study of Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma, sponsored by Alvaro Alencar, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Alvaro Alencar, MD · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies testing zanubrutinib in Lymphoma, Mantle-Cell — 12 open to participants now, 14 under way, 2 of them phase 3. zanubrutinib · Lymphoma, Mantle-Cell.

Planned enrollment
14th of 17
27 · median 45
Started
2024
with 5 others
Phase 1/2
2 of 17
1 open now
Primary completion
2028-05
later than 8 of 13 live
Registered
8th of 17
by date
Lead sponsor
1 of 17
Alvaro Alencar, MD

Among the 17 studies testing zanubrutinib in Lymphoma, Mantle-Cell, this one is the 14th largest by planned enrollment, is one of 6 that started in 2024, is one of 2 in phase 1/2, reaches primary completion later than 8 of the 13 other live ones, and was the 8th registered.

Lymphoma, Mantle-Cell

1,220 studies on the registry are indexed under Lymphoma, Mantle-Cell; 154 are open to participants now.

Browse Lymphoma, Mantle-Cell studies →

Open to participants now

12 of the 17 studies testing zanubrutinib in Lymphoma, Mantle-Cell are open now, in 4 countries. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

About zanubrutinib

zanubrutinib: first FDA approval 2019 (BRUKINSA), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 125 Lymphoma, Mantle-Cell studies recruiting now, 92 (74%) set no upper age limit and 12 (10%) stop at 75 or younger; 14 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies testing zanubrutinib in Lymphoma, Mantle-Cell, or all of them as a file.
02

Study summary

The main purpose of this study to find the ideal dose for the combination treatment of Zanubrutinib and Tafasitamab in patients with mantle cell lymphoma. Another purpose is to assess how well the combination treatment works in patients with the study disease.

03

Conditions studied

  • Mantle Cell Lymphoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Men and women ≥ 18 years of age
  2. Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification
  3. Baseline PET/CT scans must demonstrate fluorodeoxyglucose (FDG) avid lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification
  4. Patient should have indication according to primary investigator for treatment initiation
  5. (ECOG) performance status ≤ 2
  6. of greater than 4 months.
  7. Willingness to avoid pregnancy or fathering children during the study and for at least 90 days after the last dose of the study drug.
  8. Patients must have normal organ and marrow function as defined below:

    1. >1,000/mm3 independent of growth factor support within 7 days of study entry (>700/mm3 if lymphoma involvement of the bone marrow or spleen)
    2. >70,000/mm3 independent of transfusion support within 7 days of study entry (>50,000/mm3 independent of transfusion support within 7 days of study entry if lymphoma involvement of the bone marrow or spleen)
    3. >9 g/dL or >8 g/dL in case of bone marrow involvement by lymphoma independent of transfusion support within 7 days of study entry.
    4. Total \< 1.5 x within normal institutional limits (unless known history of Gilbert's disease or up to 3 x (ULN) if due to lymphoma involvement of liver)
    5. Gamma-Glutamyl Transpeptidase (GGT)/ (AST, SGOT)/Alanine transaminase (ALT, SGPT) ≤ 2.5 x institutional upper limit of normal
    6. Creatinine within normal institutional limits, or ≥ 40 mL/min (as estimated by the Cockcroft-Gault equation) for patients with creatinine levels above institutional normal (creatinine clearance ≥ 30 mL/min as estimated by the Cockcroft-Gault equation if due to lymphoma).

Inclusion Criteria, Phase 1 Only:

1. MCL patients with at least 1 but no more than 3 , regardless of previous Bruton Tyrosine Kinase (BTK) inhibitor exposure

Inclusion Criteria, Phase 2 Only:

1. Untreated symptomatic MCL deemed by the primary investigator not to be eligible for intensive combination immunochemotherapy.

Exclusion Criteria, Phase 1 and 2:

  1. Patients receiving any other agents
  2. Patients with known central nervous system involvement of lymphoma
  3. Uncontrolled intercurrent illness such as: active cardiovascular disease such as uncontrolled or symptomatic arrhythmia, uncontrolled hypertension, congestive heart failure (NYHA) Class III-IV, history of myocardial infarction within 6 months of screening, stroke in last 6 months, liver cirrhosis, disorder requiring or long-term (>10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the form
  4. corrected with Fridericia's formula (QTcF) > 450 msec or other significant abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block
  5. Prior or concurrent with exception of surgically cured carcinoma in situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for ≥5 years
  6. Concurrent malignancy requiring active therapy
  7. Known seropositive and requiring anti-viral therapy for
  8. Breastfeeding or pregnant women
  9. Serologic status reflecting active or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or antibody will need a polymerase chain reaction (PCR) below cutoff value prior to enrollment. (PCR positive patients will be excluded). Hepatitis C antibody positive patients are eligible if PCR is negative. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis
  10. Ongoing treatment with medications that are moderate or strong cytochrome P (CYP) 450, family 3, subfamily A () inhibitors, or strong CYP3A inducers that cannot be safely substituted. For patients with ongoing treatment with these medications that can be safely substituted, minimum should be 7 days or five half-lives, whichever is shorter.
  11. History of allogenic hematopoietic stem cell transplantation prior to enrollment
  12. Active systemic infection (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test) or other Active infection including infections requiring oral or intravenous antimicrobial therapy.
  13. Administration of within 28 days prior to start of study treatment
  14. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or put the study at risk.
  15. Toxicity must have recovered to ≤ Grade 1 from prior chemotherapy (except for alopecia, absolute neutrophil count, and platelet count). (Please refer to Inclusion Criteria 7 and 8 for absolute neutrophil count and platelet count, respectively.)
  16. Unable to swallow capsules, or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  17. Prior corticosteroids in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days of the start of study drug. Prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks, antineoplastic therapy with Chinese herbal medication or antibody-based therapies within 4 weeks of the start of study drug.
  18. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  19. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
  20. Major surgery within 4 weeks of the first dose of study drug
  21. Patient requires treatment with warfarin or other vitamin K antagonists
  22. Any per Tafasitamab United States Prescribing Information (USPI).
  23. Patients with impaired decision-making capacity.
Terms in these criteria, in plain language(28)

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

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.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

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.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    Zanu-Tafa Phase 1 Group

    Participants in this group will receive combination therapy of Zanubrutinib (Zanu) and Tafasitamab (Tafa) for up to 24 cycles, followed by maintenance therapy with Zanubrutinib until progression. Each cycle is 28 days in length. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years.

    Drug: Zanubrutinib · Drug: Tafasitamab

  • Experimental
    Zanu-Tafa Phase 2 Group

    Participants in this group will receive the combination therapy of Zanubrutinib (Zanu) at the recommended phase 2 dose (RP2D) determined during Phase 1, and Tafasitamab at standard doses, followed by maintenance therapy with Zanubrutinib until progression.. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years.

    Drug: Zanubrutinib · Drug: Tafasitamab

Interventions

  • Participants will be administered Zanubrutinib orally (PO) via capsules daily during each 28-day cycle at the following dose levels: * Phase 1 Dose Level 1: 320 mg * Phase 1 Dose Level -1: 240 mg * Phase 2: Recommended dose determined in Phase 1.

  • Participants will be administered a 12 mg/kg dose of Tafasitamab intravenously (IV) during each 28-day cycle as follows: * Early Induction - Cycle 1: Days 1, 4, 8, 15, and 22 * Early Induction - Cycles 2 and 3: Days 1, 8, 15 and 22 * Late Induction - Cycles 4 through 12: Days 1 and 15

06

What researchers measure

Primary outcomes

  1. Phase 1: Recommended Phase 2 Dose (RP2D) of Zanubrutinib

    Determination of the RP2D of Zanubrutinib, when used in combination with Tafasitamab, based on evaluation of dose limiting toxicity (DLT) in participants during the Phase 1 part of the study. DLT will be defined as the occurrence of specified adverse events (AEs) at least possibly related to the study therapy during the DLT review period.

    Time frame: 4 weeks

  2. Phase 2: Rate of Complete Response (CR) to Zanubrutinib at RP2D

    The complete response (CR) rate among study participants in Phase 2 to Zanubrutinib at the RP2D in combination with Tafasitamab will be assessed. Response will be assessed using positron emission tomography (PET)/computerized tomography (CT) according to the Lugano 2014 criteria. CR will be defined by a Deauville score of less than or equal to (≤) 3.

    Time frame: Up to 48 weeks

Secondary outcomes

  1. Overall Response Rate (ORR)

    The overall response rate (ORR) in study participants will be assessed. ORR will be defined at the percentage of participants achieving complete response (CR) or partial response to study therapy at at the end of early (cycles 1-3) and late induction (cycles 4-12). Response to treatment will be assessed using PET/CT according to Lugano 2014 criteria after weeks 12 and 48 of treatment. CR will be defined by a Deauville score of ≤ 3, and PR by a Deauville score of 4 or 5 with reduced uptake from baseline.

    Time frame: Up to 48 weeks

  2. Progression-free Survival (PFS)

    Progression-free survival among study participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until disease progression or death.

    Time frame: Up to 48 months

  3. Overall Survival (OS)

    Overall survival (OS) among study participants will be assessed during treatment and clinical follow-up. OS is defined from start of treatment until death from any cause.

    Time frame: Up to 48 months

  4. Number of Participants Experiencing Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    The dosing, safety, and feasibility of combination of Zanubrutinib and Tafasitamab will be assessed and reported among study participants in Phase 1 as the number of participants experiencing treatment-related toxicity after start of study therapy, including treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

    Time frame: Up to 27 months

  5. Phase 2: Duration of Response (DOR)

    The duration of response (DOR) among study participants will be assessed during treatment and clinical follow-up. DOR is defined as the time from randomization to disease progression or death in patients who achieve complete response (CR) or partial response (PR).

    Time frame: Up to 48 months

  6. Phase 2: Time to Next Treatment (TTNT)

    Time to next treatment (TTNT) is defined as the time between the date of initiation of proposed treatment and the date of next subsequent systemic treatment initiation. For participants who do not have a subsequent treatment, the TTNT will be censored at last date known to be alive, except that death from any cause will be considered a competing risk event.

    Time frame: Up to 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for May 2028, 47 months after the start.

Of 51 non-industry phase 1/2 interventional studies under Lymphoma, Mantle-Cell, half reached primary completion within 78 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 122. This study's planned 47 months is below that.

Counting every sponsor, half of 77 studies reached it within 75 months; a quarter within 45 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2023
First posted
Sep 8, 2023
StartActual
May 3, 2024
Primary completionEst.
May 1, 2028
CompletionEst.
May 1, 2032
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06029309
Lead sponsor
Alvaro Alencar, MD
Responsible party
Alvaro Alencar, MD (Associate Professor of Clinical Medicine, University of Miami) — Sponsor-investigator
First posted
Sep 8, 2023
Start date
May 3, 2024
Primary completion
May 1, 2028 (estimated)
Completion
May 1, 2032 (estimated)
Last update
Sep 21, 2026

Study contacts

Alvaro Alencar, MD
Contact
aalencar@med.miami.edu
(305) 243-4372
Alvaro Alencar, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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