Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04074746|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : June 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Anaplastic Large Cell Lymphoma Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Classic Hodgkin Lymphoma Recurrent Mycosis Fungoides Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified Refractory Anaplastic Large Cell Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Refractory Classic Hodgkin Lymphoma Refractory Mycosis Fungoides Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified||Biological: Anti-CD30/CD16A Monoclonal Antibody AFM13 Drug: Cyclophosphamide Drug: Fludarabine Drug: Fludarabine Phosphate Biological: Genetically Engineered Lymphocyte Therapy||Phase 1|
I. To establish the safety and recommended phase II dose of umbilical cord blood (CB)-derived natural killer (NK) cells preloaded with the bispecific antibody AFM13 (AFM13-NK), followed by intravenous anti-CD30/CD16A monoclonal antibody AFM13 (AFM13) in patients with refractory/relapsed CD30-positive lymphoid malignancies.
I. To assess the overall response rate (ORR), complete response (CR) rate and partial response (PR) rate.
II. To evaluate the duration of response. III. To evaluate the event-free survival (EFS) rate. IV. To evaluate the overall survival (OS) time. V. To quantify the persistence of infused donor CB AFM13-NK cells in the recipient.
VI. To conduct comprehensive immune reconstitution studies.
OUTLINE: This is a dose-escalation study of AFM13-NK.
Patients receive standard of care fludarabine intravenously (IV) over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -4 to -2, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21.
After completion of study treatment, patients are followed up at 28 days, 8 weeks, 100 and 180 days and then every 3-6 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas|
|Actual Study Start Date :||July 18, 2020|
|Estimated Primary Completion Date :||April 15, 2023|
|Estimated Study Completion Date :||April 15, 2023|
Experimental: Treatment (AFM13-NK, AFM13)
Patients receive two cycles of standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -4 to -2, AFM13-NK IV over 30 minutes on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21.
Biological: Anti-CD30/CD16A Monoclonal Antibody AFM13
Other Name: AFM13
Other Name: Fluradosa
Drug: Fludarabine Phosphate
Biological: Genetically Engineered Lymphocyte Therapy
Given AFM13-NK cells IV
- Incidence of adverse events [ Time Frame: Up to 2 years ]Adverse events will be summarized by dose.
- Overall survival [ Time Frame: Up to 2 years ]Distribution will be estimated using Kaplan-Meier method.
- Event-free survival [ Time Frame: Up to 2 years ]Distribution will be estimated using Kaplan-Meier method.
- Overall response rate (ORR) [ Time Frame: Up to 2 years ]Will be determined by ratio of responses over number of patients with measurable lesions. Logistic regression will be used to assess the association between ORR and disease and demographic covariates of interest.
- Complete response (CR) rate [ Time Frame: Up to 2 years ]Will be determined by ratio of CRs over number of patients with measurable lesions.
- Partial response (PR) rate [ Time Frame: Up to 2 years ]Will be determined by ratio of PRs over number of patients with measurable lesions.
- Duration of response [ Time Frame: Time of initial response to disease relapse/progression, assessed up to 2 years ]
- Persistence of infused donor AFM13-NK cells [ Time Frame: Up to 2 years ]Will be summarized with descriptive statistics.
- Immune reconstitution studies [ Time Frame: Up to 2 years ]Will be summarized with descriptive statistics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074746
|Contact: Yago L Nietofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Yago L. Nieto 713-792-8750|
|Principal Investigator: Yago L. Nieto|
|Principal Investigator:||Yago L Nieto||M.D. Anderson Cancer Center|