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Immunomodulatory imide drugs (IMiDs)

Tafasitamab for Central Nervous System Lymphoma

Phase 1 & 2
Recruiting
Led By James Rubenstein, MD, PhD
Research Sponsored by James Rubenstein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Participants must have histologically or cytologically confirmed relapsed primary or secondary B-cell CNS lymphoma, DLBCL type (recurrence documented by flow-cytometry is also acceptable).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial will test a new combination therapy for relapsed central nervous system lymphoma. This is the first study to use this particular therapy, which includes an anti-CD19 antibody and an immunomodulatory drug, in patients with this type of lymphoma. The hypothesis is that the therapy will increase blood-brain barrier permeability, which could have wide-ranging implications.

Who is the study for?
Adults with relapsed B-cell CNS lymphoma, including those who've had stem cell transplants but not recent anti-cancer treatments or certain other therapies. Must have good organ function and no serious medical issues that could affect safety. Women of childbearing age must agree to pregnancy testing and use contraception.Check my eligibility
What is being tested?
The trial is exploring the effectiveness of Tafasitamab combined with Lenalidomide in patients with relapsed CNS lymphoma. It's an open-label study, meaning everyone knows what treatment they're getting, focusing on how well this combination crosses the blood-brain barrier.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system, such as infusion reactions from Tafasitamab and birth defects if taken during pregnancy due to Lenalidomide. Other risks may involve changes in blood counts and liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My B-cell CNS lymphoma has returned, confirmed by tests.
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My hepatitis B virus load is undetectable with treatment.
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My blood counts and liver/kidney functions are within normal ranges.
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My cancer has spread to my brain, spinal cord, and eyes.
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I have had treatment specifically for lymphoma in my brain.
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I am mostly active and can care for myself.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) (Phase 1)
Percentage of participants with demonstrated Clinical Benefit Rate (CBR) (Phase 2)
Proportion of participants with dose limiting toxicities (DLTs) (Phase 1)
+1 more
Secondary outcome measures
Median Overall Survival (OS)
Median Progression-free survival (PFS) (Phase 2)
Proportion of participants with Treatment-Related Adverse Events

Side effects data

From 2023 Phase 2 trial • 81 Patients • NCT02399085
64%
Any TEAE
49%
Neutropenia
37%
Diarrhoea
37%
Anaemia
30%
Cough
28%
Thrombocytopenia
26%
Asthenia
25%
Oedema peripheral
22%
Pyrexia
22%
Decreased appetite
20%
Back pain
19%
Hypokalaemia
19%
Constipation
16%
Fatigue
15%
Vomiting
15%
Bronchitis
15%
Muscle spasms
15%
Nausea
12%
Leukopenia
12%
Urinary tract infection
12%
Dyspnoea
11%
Respiratory tract infection
11%
C-reactive protein increased
10%
Abdominal pain
10%
Nasopharyngitis
10%
Upper respiratory tract infection
10%
Pruritus
10%
Rash
10%
Pain in extremity
10%
Hypomagnesaemia
9%
Rhinitis
9%
Pneumonia
9%
Headache
9%
Paraesthesia
9%
Blood creatinine increased
9%
Hypertension
7%
Abdominal pain upper
7%
Sinusitis
7%
Mucosal inflammation
7%
Gastroenteritis
7%
Gamma-glutamyltransferase increased
7%
Anxiety
7%
Oropharyngeal pain
7%
Arthralgia
7%
Hypotension
6%
Febrile neutropenia
6%
Dysuria
6%
Blood alkaline phosphatase increased
6%
Sciatica
6%
Hyperglycaemia
6%
Productive cough
6%
Rash maculo-papular
6%
Lymphopenia
6%
Hypocalcaemia
6%
Hypogammaglobulinaemia
6%
Infusion related reaction
4%
COVID-19
4%
Pulmonary embolism
2%
Basal cell carcinoma
2%
Lower respiratory tract infection
2%
Squamous cell carcinoma
2%
Atrial fibrillation
2%
Cardiac failure congestive
1%
Cardio-respiratory arrest
1%
Bowen's disease
1%
Escherichia bacteraemia
1%
Gastroenteritis rotavirus
1%
Cholecystitis
1%
Haematoma
1%
Influenza
1%
Cerebrovascular accident
1%
Cervicobrachial syndrome
1%
Bronchopulmonary aspergillosis
1%
Febrile infection
1%
Transient ischaemic attack
1%
Myelodysplastic syndrome
1%
Lung adenocarcinoma
1%
Transient global amnesia
1%
Sudden death
1%
Breast cancer
1%
Myeloproliferative neoplasm
1%
COVID-19 pneumonia
1%
Klebsiella sepsis
1%
Enterobacter bacteraemia
1%
Intervertebral discitis
1%
Prostate cancer
1%
Cytomegalovirus infection
1%
Neutropenic sepsis
1%
Parainfluenzae virus infection
1%
Progressive multifocal leukoencephalopathy
1%
Respiratory syncytial virus infection
1%
Sepsis
1%
Soft tissue infection
1%
Streptococcal sepsis
1%
Urinary tract infection enterococcal
1%
Varicella zoster virus infection
1%
Lower limb fracture
1%
Wound complication
1%
Tumour flare
1%
Biliary colic
1%
Muscular weakness
1%
Agranulocytosis
1%
Cardiac failure
1%
Myocardial ischaemia
1%
Cognitive disorder
1%
Facial paralysis
1%
Chronic obstructive pulmonary disease
1%
Respiratory failure
1%
Arthritis
1%
Osteonecrosis
1%
Pathological fracture
1%
Femur fracture
1%
Renal failure
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (MOR00208, Lenalidomide)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 (Tafasitamab, Lenalidomide)Experimental Treatment2 Interventions
Participants will be given 12mg of Tafasitamab on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2 & 3, and days 1 and 15 for any cycle thereafter. Participants will also be given daily Lenalidomide on days 1-21 of each cycle at the recommended phase 2 dose.
Group II: Phase 1 (Tafasitamab, Lenalidomide)Experimental Treatment2 Interventions
Participants will be given 12mg of Tafasitamab on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2 & 3, and days 1 and 15 for any cycle thereafter. Participants will also be given daily Lenalidomide on days 1-21 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tafasitamab
2016
Completed Phase 2
~180
Lenalidomide
2005
Completed Phase 2
~1070

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lenalidomide and tafasitamab are promising treatments for Central Nervous System (CNS) Lymphoma due to their complementary mechanisms of action. Lenalidomide enhances the immune response by boosting T-cell and natural killer (NK) cell activity, while also inhibiting angiogenesis and cytokine release. Tafasitamab, an anti-CD19 monoclonal antibody, targets the CD19 antigen on B-cells, leading to cell death through antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis. This combination is particularly significant for CNS Lymphoma patients as it may improve the immune system's ability to penetrate the blood-brain barrier and effectively target lymphoma cells within the CNS.
Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.

Find a Location

Who is running the clinical trial?

James RubensteinLead Sponsor
2 Previous Clinical Trials
39 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
370 Previous Clinical Trials
55,577 Total Patients Enrolled
James Rubenstein, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
86 Total Patients Enrolled
~13 spots leftby Sep 2025
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