A Study to Find a Suitable Dose of ASP2802 in People With CD20-positive B-cell Lymphomas

NCT06248086 | Terminated Phase 1 DMC

• 1 other identifier: 2802-CL-0101
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

CAR-T cell therapy is a type of treatment for people with certain lymphomas. T-cells are white blood cells that help to fight infections. CAR-T cell therapy improves the body's T-cells to help them better fight cancer cells. ASP2802 is a type of CAR-T cell therapy given with MA-20. MA-20 is a protein that helps the CAR-T cell therapy work inside the body. Before ASP2802 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose for future studies and check for potential medical problems from the treatment. In this study, ASP2802 is being tested in humans for the first time. ASP2802 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed. People taking part in this study will be adults with CD20-positive B-cell lymphomas. CD20 is a protein found on a type of white blood cell called a B-cell. Some people with B-cell lymphomas have more CD20 on these cells. Their cancer will have come back after it had disappeared with earlier therapy (relapsed) or it will have become resistant to previous treatment (refractory). The main aims of the study are to check the safety of ASP2802, how well it is tolerated, and to find a suitable dose of ASP2802. This is an open-label, adaptive study. Open-label means that people in this study and clinic staff will know that people will receive ASP2802 treatment. Adaptive means the treatments may change, depending on earlier results in the study. There will be 3 groups of people in this study and 3 doses of ASP2802. Groups A, B and C will receive ASP2802 treatment. Group A will start treatment first with a low dose of ASP2802. If Group A tolerates the low dose of ASP2802, then Group B will receive the higher dose of ASP2802. If Group B tolerates the higher dose of ASP2802, then Group C will receive the highest dose of ASP2802. There are several steps in this treatment. First, T-cells are removed from the blood by inserting a small tube (cannula) into a vein and connecting it to a machine that separates out the blood cells. The machine collects the T-cells and returns the rest of the blood cells back into the bloodstream. The collected T-cells are sent to the lab to be changed into improved T-cells (with ASP2802) to fight the cancer. This may take several weeks, so people in the study may receive extra treatment, to keep the cancer under control during this time. Before the improved T-cells go back in the body, people will visit the clinic so that the study doctors can do a series of checks to make sure they are well enough to receive the T-cells. A few days before the improved T-cells go back into the body, people in the study will have chemotherapy for 3 days. This is to make sure the cancer is at its lowest level before people are treated with ASP2802. Then, the improved T-cells are fed back into the bloodstream using a drip attached to the cannula. After this, a booster of MA-20 will be given at the set dose by infusion on Day 3 and Day 17 in a 28-day cycle. If people respond well to treatment, they may stay on the same dose during the next cycle; if they have medical problems from the treatment, they may get a lower dose during the next cycle. The next group of people may receive a different dose (higher or lower) of MA-20 depending on the results from the previous group. People in the study will continue receiving MA-20 in this way until: they have certain medical problems from the treatment on the lowest dose of MA-20; they start other cancer treatment; their cancer gets worse; they or the study doctor decides they should stop treatment; they do not come back for treatment. After treatment has finished, people in the study will visit the clinic regularly for 2 years and continue to be monitored for up to 15 years. Some people may be treated again with MA-20. This may happen for people who have responded to treatment and then relapse within a year, or for people that have a partial response and have a slow growing lymphoma. During the study, people will visit the study hospital many times. During most visits, the study doctors will do a medical examination, blood tests and check vital signs. Vital signs include temperature, breathing rate, blood pressure, blood oxygen levels, and heart rate. They will also check for medical problems. In some visits, computerized tomography (CT) scans and electrocardiograms (ECGs) to check the heart rhythm will also be done. People will have several hospital stays during their treatment. This may be during their chemotherapy, then from Days -1 to 7 and Days 17 to 21 during the cycle 1 of MA-20. Day -1 means 1 day before treatment with ASP2802. During this time, people will be closely monitored for medical problems, have EGCs and have a biopsy taken. During the extra cycles of MA-20, there will be the option of staying overnight.

Conditions

B-cell Lymphoma

Keywords

relapsed CD20-positive; refractory CD20-positive; CAR-T cell therapy; ASP2802

Outcome Measures

Primary Outcomes (7)

• Incidence of Dose Limiting Toxicities (DLTs)

  A DLT is defined as any event meeting the DLT criteria occurring within 28 days after ASP2802 (MACT) infusion and/or 28 days after the first dose of each administered dose of MA-20 during the dose escalation phase not attributable to a cause other than investigational product (IP).

  Up to 10 months

• Number of participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study IP, whether or not considered related to the study IP and other study treatments. Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study IP and other study treatments. This includes events related to the (study) procedures.

  Up to 26 months

• Number of participants with Serious Adverse Events (SAEs)

  A Serious Adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event.

  Up to 26 months

• Number of participants with laboratory value abnormalities and/or AEs

  Number of participants with potentially clinically significant laboratory values.

  Up to 26 months

• Number of Participants with vital sign abnormalities and/or AEs

  Number of participants with potentially clinically significant vital sign values.

  Up to 26 months

• Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs

  Number of participants with potentially clinically significant ECG values.

  Up to 26 months

• Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores

  The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

  Up to 26 months

Secondary Outcomes (17)

• Pharmacokinetics (PK) of ASP2802 in blood: Maximum Concentration (Cmax)

  Up to 26 months

• PK of ASP2802 in blood: Time to maximum concentration (tmax)

  Up to 26 months

• PK of ASP2802 in blood: Area under the concentration-time curve (AUC)0-28d

  Up to 26 months

• PK of ASP2802 in blood: concentration

  Up to 26 months

• PK of MA-20 in serum: Cmax

  Up to 26 months

Study Arms (3)

Group A: ASP2802 Low Dose followed by MA-20

EXPERIMENTAL

Participants will receive a low dose of ASP2802 on Day 0 of cycle 1. Each participant will then receive up to 2 doses of MA-20 booster in each 28-day cycle.

Drug: ASP2802; Drug: MA-20

Group B: ASP2802 Intermediate Dose followed by MA-20

EXPERIMENTAL

Participants will receive an intermediate dose of ASP2802 on Day 0 of cycle 1. Each participant will then receive up to 2 doses of MA-20 booster in each 28-day cycle, with dose level(s) selected from Group A.

Drug: ASP2802; Drug: MA-20

Group C: ASP2802 High Dose followed by MA-20

EXPERIMENTAL

Participants will receive a higher dose of ASP2802 on Day 0 of cycle 1. Each participant will then receive up to 2 doses of MA-20 booster in each 28-day cycle, with dose level(s) selected from Group B.

Drug: ASP2802; Drug: MA-20

Interventions

ASP2802 DRUG

Intravenous (IV) infusion

Also known as: MACT

Group A: ASP2802 Low Dose followed by MA-20; Group B: ASP2802 Intermediate Dose followed by MA-20; Group C: ASP2802 High Dose followed by MA-20

MA-20 DRUG

IV infusion

Also known as: ASP101G, MicAbody

Group A: ASP2802 Low Dose followed by MA-20; Group B: ASP2802 Intermediate Dose followed by MA-20; Group C: ASP2802 High Dose followed by MA-20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has histologically-confirmed cluster of differentiation (CD) 20-positive B-cell lymphoma (CD20 expression should be demonstrated by local testing at the time of relapse or progression and within 1 month of study screening) which may include the following aggressive large cell or indolent subtypes.
• Diffuse large B-cell lymphoma (DLBCL), Not otherwise specified (NOS)
• Follicular lymphoma grade 3B
• Primary mediastinal large B-cell lymphoma
• T-cell/histiocyte-rich large B-cell lymphoma
• DLBCL associated with chronic inflammation
• Intravascular large B-cell lymphoma
• Anaplastic lymphoma kinase fusion gene (ALK)+ large B-cell lymphoma
• B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
• High grade B-cell lymphoma with proto-oncogene located on chromosome 8 (MYC) and B-cell leukemia/lymphoma 2 gene (BCL2) and/or B-cell leukemia/lymphoma 6 gene (BCL6) rearrangements
• High-grade B-cell lymphoma, NOS
• Human herpes virus type 8 (HHV8)+ DLBCL, NOS
• Primary cutaneous DLBCL, leg type
• Transformed follicular lymphoma
• Follicular lymphoma

You may not qualify if:

• Participant has been diagnosed with the following conditions:
• B-lymphoblastic leukemia/lymphoma (B-ALL/LBL)
• chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
• Burkitt lymphoma
• Richter's transformation of CLL/SLL
• Epstein-Barr virus (EBV)+ DLBCL, NOS
• Mantle cell lymphoma
• Known history or suspicion of central nervous system involvement by lymphoma.
• Participant weighs \< 45 kilograms (kg) at screening.
• Participant had prior allogeneic hematopoietic stem cell transplantation (HSCT).
• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Participant has a history of non-study related malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease free for at least 3 years.
• Participant has a history of myocardial infarction, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment or has cardiac atrial or cardiac ventricular lymphoma involvement.
• Participant has known abnormal lung function: forced expiratory volume (FEV) \< 60% prediction, diffusing capacity of the lung for carbon monoxide \< 60% prediction, blood oxygen saturation \< 90% on room air.
• Participant has intracranial hypertension or unconsciousness, respiratory failure or disseminated intravascular coagulation.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

Site AU61004

Sydney, 3065, Australia

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Central Contact

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: September 6, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)