Mantle Cell LymphomaPhase 1/2ZANU-TAFANCT06029309
Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
A Phase 1/2 study testing Zanubrutinib and Tafasitamab in people with Mantle Cell Lymphoma, run by Alvaro Alencar, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Zanubrutinib and Tafasitamab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 1 May 2032
- Phase
- Phase 1/2
- 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
- Men and women ≥ 18 years of age
- Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification
- 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
- Patient should have indication according to primary investigator for treatment initiation
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of greater than 4 months.
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- Willingness to avoid pregnancy or fathering children during the study and for at least 90 days after the last dose of the study drug.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count >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)
- Platelets >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)
- Hemoglobin >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.
- Total bilirubin < 1.5 x within normal institutional limits (unless known history of Gilbert's disease or up to 3 x upper limit of normal (ULN) if due to lymphoma involvement of liver)
- Gamma-Glutamyl Transpeptidase (GGT)/Aspartate transaminase (AST, SGOT)/Alanine transaminase (ALT, SGPT) ≤ 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits, or creatinine clearance ≥ 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).
- 1. Relapsed MCL patients with at least 1 but no more than 3 lines of therapy, regardless of previous Bruton Tyrosine Kinase (BTK) inhibitor exposure
- 1. Untreated symptomatic MCL deemed by the primary investigator not to be eligible for intensive combination immunochemotherapy.
Who cannot join
- Patients receiving any other investigational agents
- Patients with known central nervous system involvement of lymphoma
- Uncontrolled intercurrent illness such as: clinically significant active cardiovascular disease such as uncontrolled or symptomatic arrhythmia, uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) Class III-IV, history of myocardial infarction within 6 months of screening, stroke in last 6 months, liver cirrhosis, autoimmune disorder requiring immunosuppression or long-term corticosteroids (>10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- QT interval corrected with Fridericia's formula (QTcF) > 450 msec or other significant ECG abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block
- Prior or concurrent malignancies with exception of surgically cured carcinoma in situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for ≥5 years
- Concurrent malignancy requiring active therapy
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- Known seropositive and requiring anti-viral therapy for human immunodeficiency virus
- Breastfeeding or pregnant women
- Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C 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
- Ongoing treatment with medications that are moderate or strong cytochrome P (CYP) 450, family 3, subfamily A (CYP3A) inhibitors, or strong CYP3A inducers that cannot be safely substituted. For patients with ongoing treatment with these medications that can be safely substituted, minimum washout period should be 7 days or five half-lives, whichever is shorter.
- History of allogenic hematopoietic stem cell transplantation prior to enrollment
- 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.
- Administration of live vaccine within 28 days prior to start of study treatment
- 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.
- 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.)
- 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.
- 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.
- 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
- History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
- Major surgery within 4 weeks of the first dose of study drug
- Patient requires treatment with warfarin or other vitamin K antagonists
- Any contraindication per Tafasitamab United States Prescribing Information (USPI).
- Patients with impaired decision-making capacity.
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
University of Miami
Miami, Florida, 33136
Alvaro Alencar, MD, (305) 243-4372, aalencar@med.miami.edu
Alvaro Alencar, MD
About this study
Official title: A Phase 1/2 Study of Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
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.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Zanubrutinib, Tafasitamab
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
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.
TafasitamabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Zanu-Tafa Phase 1 Group | Experimental | 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. Receives: Drug: Zanubrutinib; Drug: Tafasitamab |
| Zanu-Tafa Phase 2 Group | Experimental | 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. Receives: Drug: Zanubrutinib; Drug: Tafasitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: Up to 48 weeks
Secondary outcomes (6)
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.
Measured: Up to 48 weeks
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.
Measured: Up to 48 months
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.
Measured: Up to 48 months
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.
Measured: Up to 27 months
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).
Measured: Up to 48 months
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start3 May 2024
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alvaro Alencar, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation, BeOne Medicines
- Responsible party
- Sponsor-investigator, Alvaro Alencar, MD, University of Miami
- Investigators
- Alvaro Alencar, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029309
- Sponsor's protocol ID
- 20221346
- Acronym
- ZANU-TAFA
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06029309
- Acronym / sponsor ID
- ZANU-TAFA / 20221346
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Alvaro Alencar, MDUniversity, hospital or other
- Collaborators
- Incyte Corporation, BeOne Medicines
- Study start
- 3 May 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 8 Sep 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanu-Tafa Phase 1 Group | Experimental | Drug: Zanubrutinib, Drug: TafasitamabParticipants 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. |
| Zanu-Tafa Phase 2 Group | Experimental | Drug: Zanubrutinib, Drug: TafasitamabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men and women ≥ 18 years of age
- Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification
- 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
- Patient should have indication according to primary investigator for treatment initiation
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (23 listed)
- Patients receiving any other investigational agents
- Patients with known central nervous system involvement of lymphoma
- Uncontrolled intercurrent illness such as: clinically significant active cardiovascular disease such as uncontrolled or symptomatic arrhythmia, uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) Class III-IV, history of myocardial infarction within 6 months of screening, stroke in last 6 months, liver cirrhosis, autoimmune disorder requiring immunosuppression or long-term corticosteroids (>10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- QT interval corrected with Fridericia's formula (QTcF) > 450 msec or other significant ECG abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block
- Prior or concurrent malignancies with exception of surgically cured carcinoma in situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for ≥5 years
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 |
|---|---|---|
| ZanubrutinibParticipants 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. | Drug | Zanu-Tafa Phase 1 Group, Zanu-Tafa Phase 2 Group |
| TafasitamabParticipants 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 | Drug | Zanu-Tafa Phase 1 Group, Zanu-Tafa Phase 2 Group |
Primary outcome
Phase 1: Recommended Phase 2 Dose (RP2D) of Zanubrutinib
Time frame: 4 weeks
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.
Phase 2: Rate of Complete Response (CR) to Zanubrutinib at RP2D
Time frame: Up to 48 weeks
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.
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 48 weeks
Progression-free Survival (PFS)
Time frame: Up to 48 months
Overall Survival (OS)
Time frame: Up to 48 months
Number of Participants Experiencing Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 27 months
Phase 2: Duration of Response (DOR)
Time frame: Up to 48 months
Phase 2: Time to Next Treatment (TTNT)
Time frame: Up to 24 months
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Alvaro Alencar, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zanubrutinib and Tafasitamab in people with Mantle Cell Lymphoma, run by Alvaro Alencar, MD 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 16 inclusion and 23 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 21 Sep 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Alvaro Alencar, MD ((305) 243-4372, aalencar@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Recommended Phase 2 Dose (RP2D) of Zanubrutinib (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.