A Phase Ib/II, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma.

Study Identifier:
GCT3013-02
CT.gov Identifier:
NCT04663347
EudraCT Identifier:
2020-000845-15
EU Trial (CTIS) Number:
2023-504805-35-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

Safety Run In Phase: To evaluate the safety and tolerability of epcoritamab in combination with other agents Expansion Phase: To Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents To evaluate the safety, tolerability, PK, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents in subjects with B-NHL. Step-up dosing and corticosteroids during cycle 1 were used to mitigate cytokine release syndrome (CRS). Responses were evaluated by position emission tomography–computed tomography per the 2014 Lugano classification criteria To present preliminary results from arm 2 of this trial, which is evaluating epcoritamab in combination with R2 in pts with R/R FL. To present data from arm 1 of this trial, in which epcoritamab in combination with R-CHOP is evaluated in pts with previously untreated high-risk DLBCL. PET-CT was used to assess response To present results for a larger cohort with longer follow-up. To evaluate epcoritamab SC + R-mini-CHOP in 1L DLBCL. A safety run-in was conducted to confirm acceptability of the safety profile. To report initial data from arm 8 of the phase 1/2 EPCORE™ NHL-2 study evaluating epcoritamab SC + R-mini-CHOP in 1L DLBCL. To report updated data from epcoritamab in combination with rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin (R-DHAX/C) in pts with R/R DLBCL eligible for HDT-ASCT, including high-risk pts (progressed within 12 mo of initial tx or primary refractory), from EPCORE™ NHL-2 To present data from EPCORE™ NHL-2 (phase 1/2; NCT04663347), with longer follow-up for epcoritamab + R2 in 1L FL (arm 6) and the first disclosure for epcoritamab maintenance in patients (pts) with FL in CR or partial response (PR) after 1–2 lines of standard of care (SOC) tx (arm 7). To report additional efficacy and safety results of epcoritamab + GemOx in difficult-to-treat R/R DLBCL (EPCORE™ NHL-2 phase 1/2 trial, NCT04663347). Methods: Adults with R/R CD20+ DLBCL who failed or were ineligible for autologous stem cell transplant (ASCT) enrolled to To present long-term follow-up beyond 2 y and minimal residual disease (MRD) analysis for the first time. MRD analysis was performed on peripheral blood mononuclear cell samples collected at prespecified time points (clonoSEQ® assay, Adaptive Biotechnologies) and quantified as tumor clones detected per 1 x 106 nucleated cells. To report updated results with longer follow-up from arm 8 of the EPCORE® NHL-2 trial evaluating epcoritamab + R-mini-CHOP in this population. To present long-term follow-up beyond 2 y, including in subgroups, and minimal residual disease (MRD) analyses for the first time To present initial results from arm 3 of the ongoing phase 1b/2 EPCORE NHL-2 trial evaluating fixed-duration epcoritamab + BR in 1L FL, including T-cell pharmacodynamics with this novel combination. To evaluate the safety and tolerability of epcoritamab in combination with other agents Expansion Phase: Arms 1-6 and 8-10: Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents Arm 7: Evaluate the safety and tolerability of epcoritamab following standard of care (SOC) Efficacy by baseline (BL) bulky disease (BD) status (≥ 7 cm [n = 6] vs. < 7 cm [n = 19]) was evaluated. To report the first disclosure of circulating tumor DNA (ctDNA) over time to provide insights into MRD kinetics for pts treated with epcor + GemOx. MRD was assessed using the Avenio ctDNA assay with a cutoff of negativity defined as < 1 mutant molecule/ml. MRD-evaluable pts required a baseline and ≥ 1 on-tx MRD result and MRD positivity at C1D1. Best overall response and progression-free survival (PFS), were assessed by independent review committee per Lugano criteria. To report efficacy and safety from a 3-year follow-up of patients who received epcoritamab + R-CHOP in the EPCORE NHL-2 trial. To report long term durability data from this cohort after >2 y of follow-up

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Lymphoma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with previously untreated diffuse large B-cell lymphoma (DLBCL) - Arm 2: epcoritamab + rituximab and lenalidomide (R2) in subjects with relapsed/refractory (R/R) follicular lymphoma (FL) - Arm 3: epcoritamab + rituximab and bendamustine (BR) in subjects with previously untreated FL - Arm 4: epcoritamab + rituximab, cisplatin, cytarabine, and dexamethasone (R-DHAP) in subjects with R/R DLBCL eligible for autologous stem cell transplant (ASCT) - Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in subjects with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity For each arm, there are 2 parts: Part 1 (safety run-in) and Part 2 (expansion). Within each arm, subjects can only participate in one part. Part 1 and Part 2 of each arm will consist of a screening period, a treatment period, a safety follow-up period, and a survival follow-up period. Intervention: Epcoritamab (the investigational medicinal product [IMP]) will be administered as a subcutaneous injection. The schedules of administration are as follows: Arm 1: epcoritamab + R-CHOP for 8 cycles (21-day cycles; 6 cycles of epcoritamab in combination with SOC followed by 2 cycles of epcoritamab monotherapy) Arm 2: epcoritamab + R2 until progression (28-day cycles; 12 cycles of epcoritamab in combination with SOC followed by epcoritamab monotherapy until progression or unacceptable toxicity) Arm 3: epcoritamab + BR for 8 cycles (21-day cycles; 6 cycles in combination with SOC followed by 2 cycles of epcoritamab monotherapy) Arm 4: epcoritamab + R-DHAP until high-dose therapy with autologous stem cell transplant (HDT-ASCT) (21-day cycles; 3 cycles of epcoritamab in combination with SOC followed by epcoritamab monotherapy until conditioning for transplant) Arm 5: epcoritamab + GemOx until progression (28-day cycles; 4 cycles in combination with SOC followed by epcoritamab monotherapy until progression or unacceptable toxicity) Experimental: Arm 1 - Epcoritamab + R-CHOP In participants with previously untreated DLBCL. Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone 6 cycles (21-day cycles) Biological: Epcoritamab Every week in cycle 1-4, every 3 weeks in cycle 5 and 6, followed by every 4 weeks in cycle 7 for a total of 1 year. Experimental: Arm 2 - Epcoritamab + R2 In participants with R/R FL. Biological: Epcoritamab Eligible participants will receive subcutaneous (SC) epcoritamab in 28-day cycles. Fixed-treatment epcoritamab will be administered following a 2-Set Up Dosing regimen in Cycle 1. There will be 2 cohorts, 2a and 2b with different dosing schedules. Cohort 2a will be dosed weekly (QW) in Cycles 1-3, once every 2 weeks (Q2W) in Cycles 4-9, and once every 4 weeks (Q4W) in Cycle 10 and beyond for up to 2 years. In cohort 2b, an alternate dosing schedule for epcoritamab will be explored: epcoritamab administered QW for Cycles 1-2 only, then Q4W in Cycle 3 and beyond for up to 2 years. Biological: Epcoritamab Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years. Experimental: Arm 3 - Epcoritamab + BR In participants with previously untreated FL. Drug: rituximab and bendamustine 6 cycles (28-day cycles) Biological: Epcoritamab Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody-CD3xCD20 EPKINLY Experimental: Arm 4 - Epcoritamab + R-DHAX/C In participants with R/R DLBCL eligible for ASCT. Drug: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin 3 cycles (28-day cycles) Other Name: R-DHAX/C Biological: Epcoritamab Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years. Experimental: Arm 5 - Epcoritamab + GemOx In participants with R/R DLBCL ineligible ASCT. Drug: gemcitabine and oxaliplatin 4 cycles (28-day cycles) Other Name: GemOx Biological: Epcoritamab Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity. Experimental: Arm 6 - Epcoritamab + R2 In participants with previously untreated FL. rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles) Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Experimental: Arm 7 - Epcoritamab maintenance In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L. Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody-CD3xCD20 EPKINLY Experimental: Arm 8 - Epcoritamab + R mini-CHOP In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline. Drug: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone 6 cycles (21-day cycles) Biological: Epcoritamab Every week in cycles 1 and 2, then every 3 weeks in cycles 3 to 6 and then every 4 weeks for cycles 7 and 8. Other Names: GEN3013 DuoBody-CD3xCD20 EPKINLY Experimental: Arm 9 - Epcoritamab + Lenalidomide In participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy. Drug: Lenalidomide 12 cycles (28-day cycles) Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody-CD3xCD20 EPKINLY Experimental: Arm 10 - Epcoritamab + R-ICE In participants with R/R DLBCL eligible for ASCT. Drug: rituximab, ifosfamide, carboplatin, and etoposide phosphate 3 cycles (28-day cycles) Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression. Other Names: GEN3013 DuoBody-CD3xCD20 EPKINLY ASH 2021: Patients received epcoritamab in a dose-escalation phase followed by an expansion phase at the recommended phase 2 dose in combination with R2 for 12 cycles (28 days/cycle). ASH 2021: received flat-dose epcoritamab in combination with standard R-CHOP for 6 cycles followed by epcoritamab monotherapy. The study includes a dose-escalation cohort (epcoritamab doses: dose level 1 = 24 mg; dose level 2 = 48 mg). ASCO 2022 Pts received standard R-DHAX/C with subcutaneous epcoritamab (QW, 21-d cycle [C] 1-3). If HDT-ASCT was postponed, pts could continue epcoritamab monotherapy (28-d C: QW, C4; Q2W, C5-9; Q4W, C≥10) until disease progression or unacceptable toxicity. Step-up epcoritamab dosing and corticosteroids were required to mitigate CRS in C1. Patients will receive subcutaneous epcoritamab + R2for 12 cycles (28 d/cycle). In the dose-escalation part of the trial, epcoritamab was administered at 24 or 48 mg; in the expansion part, the dose was 48 mg. Pts received their assigned epcoritamab dose as follows: every wk, cycles 1-3; every 2 wk, cycles 4-9; and every 4 wk, cycles ≥10 up to 2 y. Corticosteroid prophylaxis and step-up epcoritamab dosing were required during cycle 1 to mitigate CRS. Pts received epcoritamab (weekly, cycle [C] 1-3; every 2 wk, C4-9; every 4 wk, C≥10) and GemOx (every 2 wk, C1-4) until disease progression or unacceptable toxicity (28 d/C). ASTCT 2023: Pts with R/R CD20+ DLBCL eligible for HDT-ASCT received epcoritamab+ R-DHAX/C in 21-d cycles (QW, cycles 1-3). Pts continued epcoritamab monotherapy if HDT-ASCT was deferred (21-d cycle: QW, cycle 4; 28-d cycles: Q2W, cycles 5-9, and Q4W, cycles ≥10) until disease progression or unacceptable toxicity. Step-up epcoritamab dosing and corticosteroid prophylaxis were required in cycle 1 to mitigate CRS. ASCO 2023 Patients received epcoritamab SC + R2 for 12 cycles (Cs; 28 d each). Epcoritamab was dosed QW in C1-3, Q2W in C4-9, and Q4W in C≥10 (2a) or QW in C1-2 and Q4W in C≥3 (2b) for ≤2 y. ll participants in the trial will receive epcoritamab, as monotherapy or in combination. The following regimens will be investigated: Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated diffuse large B-cell lymphoma (DLBCL) Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL) Arm 3: epcoritamab + rituximab and bendamustine (BR) in participants with previously untreated FL Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in participants with R/R DLBCL eligible for autologous stem cell transplant (ASCT) Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity Arm 6: epcoritamab + R2 in participants with previously untreated FL Arm 7: epcoritamab maintenance in participants with FL who achieve a complete response (CR) or a partial response (PR) with SOC treatment Arm 8: epcoritamab + reduced dose of R-CHOP (R mini-CHOP) in participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline Arm 9: epcoritamab + lenalidomide for second-line treatment in participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy Arm 10: epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in participants with R/R DLBCL eligible for ASCT The trial consists of two parts: Part 1 ('Dose Escalation') and Part 2 ('Dose Expansion'). The primary objective of Part 1 is safety, and it includes Arm 1-5 and Arm 10. Part 2 includes all 10 arms (Arm 1-10) and the primary goal of all arms, except Arm 7, is preliminary efficacy. For Arm 7, the primary goal is safety. Patients in Arm 1-5 and Arm 10 can only participate in either Part 1 or Part 2. Dose Limiting Toxicities (DLTs) will be assessed in Part 1 and for a selected number of patients in Arm 8 during a 28-day period ('safety-run phase'). The arms are conducted in parallel. Patients with R/R CD20+ FL received subcutaneous epcoritamab + R2 for 12 cycles (28 d each). Epcoritamab was dosed QW in cycles 1-3, Q2W in cycles 4-9, and Q4W in cycles ≥10 (2a) or QW in cycles 1-2 and Q4W in cycles ≥3 (2b) for ≤2 y. ICML 2023: Patients with 1L CD20+ DLBCL and IPI ≥3 received subcutaneous epcoritamab (cycles 1-4, QW; cycles 5-6, Q3W) + R-CHOP for 6 cycles (21 days each) followed by epcoritamab monotherapy Q4W (28-day cycles) up to a total of 1 year. Patients received epcoritamab SC in 28-d cycles (Cs) as follows: weekly, C1-3; every 2 weeks, C4-9; every 4 weeks, C≥10 until progressive disease or unacceptable toxicity. Patients received GemOx every 2 weeks in C1-4. Step-up epcoritamab dosing (step-up doses 1 and 2 followed by 48-mg full doses) and corticosteroid prophylaxis were required in C1 to mitigate CRS. Patients received epcoritamab SC (QW, cycles 1-2 [21 d each]; Q3W, cycles 3-6 [21 d each]; Q4W, cycles 7-8 [28 d each]) with R-mini-CHOP in cycles 1-6 (Q3W). Pts received epcoritamab SC (QW, cycle [C] 1-2 [21 d each]; Q3W, C3-6 [21 d each]; Q4W, C7-8 [28 d each]) with R-mini-CHOP in C1-6 (Q3W). A safety run-in was conducted. Adults with 1L CD20+ FL Grade 1-3A received subcutaneous epcor+BR for 6, 28-d cycles (C), followed by epcor monotherapy (up to 2 y). Two step-up epcor doses (0.16- and 0.8-mg) in C1 were followed by 48-mg doses (QW 1-3, Q2W 4-9, Q4W C10+ up to 2 y). ASCO 2024: Patients received R-DHAX/C and epcoritamab (2 step-up doses, then 24- or 48-mg full doses) in 21-d cycles (Cs): QW, C1-3. If HDT-ASCT was deferred, pts could continue epcoritamab (21-d C: QW, C4; 28-d Cs: Q2W, C5-9; Q4W, C≥10) until disease progression. Patients received subcutaneous epcoritamab 48 mg. In arm 6, pts received R2 for ≤12 cycles (Cs) of 28 d and epcoritamab (QW, C1-2; Q4W, C3-26). In arm 7, pts received epcoritamab (QW, C1 [28 d]; Q8W, C2-13 [56 d/C]). Pts received step-up epcoritamab dosing and corticosteroid prophylaxis in C1 to mitigate CRS. HDT-ASCT were treated with R-DHAX/C and subcutaneous epcoritamab (2 step-up doses, followed by 24- or 48-mg full doses) in 21-d cycles (Cs): QW, C1-3. Pts could continue epcoritamab monotherapy until disease progression if HDT-ASCT was deferred (21-d C:QW, C4; 28-d Cs: Q2W, C5-9; Q4W, C≥10). ASH 2024: Pts received fixed-duration subcutaneous epcoritamab (QW, cycles [Cs] 1-2 [21 d each]; Q3W, C3-6 [21 d each]; Q4W, C7-8 [28 d each]; with step-up dosing in C1 [0.16 mg on C1D1 and 0.8 mg on C1D8]) + R-mini-CHOP (Q3W, C1-6). Patients received subcutaneous epcoritamab (QW in cycles 1-4; Q3W in cycles 5-6) + R-CHOP for 6 cycles (21 d each) followed by epcoritamab monotherapy Q4W in 28d cycles for up to 1 y. Adults with 1L CD20+ FL grade 1-3A received subcutaneous epcoritamab + BR for 6 cycles (Cs; 28 d each) followed by epcoritamab monotherapy. Epcoritamab was administered with a 2-step (0.16 mg and 0.8 mg) step-up dosing regimen in C1 followed by 48-mg full doses (QW in C1-3, Q2W in C4-9, and Q4W thereafter for up to 2 y) Patients received SC epcor (2 step-up doses followed by 48-mg full doses) in 28-d cycles (C): QW, C1-3; Q2W, C4-9; Q4W, C ≥ 10 until disease progression. GemOx was given Q2W in C1-4. ASH 2025: Patients received subcutaneous epcoritamab (0.16 mg on cycle 1 [C1] day 1 [D1], 0.8 mg on C1D8, and 48 mg thereafter; QW in C1–4; Q3W in C5–6) + R-CHOP for 6 Cs (21 days each), followed by epcoritamab monotherapy Q4W in 28-day Cs for a total of 1 year of treatment. In Arm 6, pts with CD20+ FL grade (Gr) 1–3A received SC epcor 48 mg (QW, cycles [C]1–2; Q4W thereafter for ≤2 years) with IV rituximab 375 mg/m2 (QW, C1; Q4W, C2–6) and oral lenalidomide20 mg (QD, days 1–21, C1–12). In Arm 7, pts in complete (CR) or partial (PR) response after 1–2 prior lines of SOC received epcor 48 mg maintenance monotherapy (QW, C1 [28 days]; Q8W, C2–13 [56-day cycles]) for up to 2 years.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms except arm 7.
    • Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
    • Acceptable organ function at screening
    • CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
    • If of childbearing potential participant must practicing a highly effective method of birth control
    • A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
    • Arm 1:
    • Newly Diagnosed Documented diffuse large B-cell lymphoma (DLBCL)
    • DLBCL, NOS
    • “double-hit“ or “triple-hit“ DLBCL
    • FL Grade 3B
    • Arm 2: R/R FL
    • Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
    • Arm 4:
    • Documented DLBCL and eligible for HDT-ASCT
    • DLBCL, NOS
    • “double-hit“ or “triple-hit“ DLBCL
    • FL Grade 3B
    • Arm 5:
    • Relapsed or refractory documented DLBCL and ineligible for HDT-ASCT
    • DLBCL, NOS
    • “double-hit“ or “triple-hit“ DLBCL
    • FL Grade 3B
    • Arm 6: Newly diagnosed, previously untreated FL grade 1-3A
    • Arm 7:
    • FL Grade 1-3A
    • If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.
    • Arm 8:
    • DLBCL, NOS
    • T-cell/histiocyte rich DLBCL
    • “double-hit“ or “triple-hit“ DLBCL
    • FL Grade 3B
    • Arm 9:
    • R/R FL
    • Progressed within 24 months of initiating first-line treatment
    • Arm 10:
    • Documented DLBCL and eligible for HDT-ASCT
    • DLBCL, NOS
    • "double-hit" or "triple-hit" DLBCL
    • FL Grade 3B
    • Adults with R/R CD20+ DLBCL who had failed or were ineligible for ASCT were enrolled
    • Adults with 1L CD20+ DLBCL who were not considered candidates for full-dose R-CHOP due to age ≥75 y or age ≥65 y with comorbidities (reduced left ventricular ejection fraction, history of myocardial infarction [>6 mo prior to enrollment], exertional chest pain, arrhythmia [grade ≤2], hypertension requiring treatment, or diabetes) were enrolled.
    • Adult pts with 1L CD20+ DLBCL who were not considered candidates for full‑dose R-CHOP (age ≥75 y or age ≥65 y with comorbidities) were enrolled.
    Exclusion criteria
    • Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
    • Any prior treatment with a bispecific antibody targeting CD3 and CD20.
    • Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
    • Clinically significant cardiovascular disease
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
    • CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
    • Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
    • Known history of seropositivity of human immunodeficiency virus (HIV)
    • Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
    • Neuropathy > grade 1
    • Receiving immunostimulatory agent
    • Prior allogeneic HSCT
    • Current seizure disorder requiring anti-epileptic therapy

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Daniel Morillo Giles
    Status
    Recruiting
    Condition(s) Treated at Site
    Lymphoma