Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04512716|
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|B-ALL DLBCL B ALL Dlbcl-Ci DLBCL Unclassifiable DLBCL, Nos Genetic Subtypes DLBCL Activated B-Cell Type DLBCL Germinal Center B-Cell Type Diffuse Large B-cell Lymphoma HGBL HGBL, Nos||Drug: 131-I Apamistamab Biological: CAR T-cell||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma|
|Actual Study Start Date :||February 2, 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: B-Cell Acute Lymphoblastic Leukemia/Diffuse Large B-Cell Lym
Participants will have relapsed or refractory B-Cell Acute Lymphoblastic Leukemia or Diffused Large B-Cell Lymphoma
Drug: 131-I Apamistamab
Patients will receive 131-I apamistamab 75 mCi 5-7 days prior to a single infusion of 1x10^6 19-28z CAR T-cells/kg for those in the B-ALL cohort, or 2x10^6 19-28z CAR T-cells/kg, for those in the DLBCL. 131-I apamistamab may be administered inpatient or outpatient at the discretion and judgment of the treating investigators.
Other Name: Iomab-B
Biological: CAR T-cell
19-28z CAR T-cells will be administered inpatient as a single infusion of 1x10^6 19-28z CAR T-cells/kg, for those in the B-ALL cohort, or 2x10^6 19-28z CAR T-cells/kg, for those in the DLBCL cohort. Patients will be observed inpatient for a minimum of 7 days (longer as clinically indicated and at the discretion of the treating physician).
- Dose-limiting toxicities and maximum tolerated dose of 131-I apamistamab, when given in combination with 19-28z CAR T-cells for treatment of relapsed or refractory B-cell ALL or DLBCL [ Time Frame: 30 days after treatment ]To determine the safety and tolerability of a single 75 mCi dose of 131-I apamistamab given prior to 19-28z CAR T-cell infusion in patients with relapsed or refractory B-cell ALL or DLBCL.
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): NCT04512716
|Contact: Mark B Geyer, MDfirstname.lastname@example.org|
|Contact: Neeta Pandit-Taskar, MDemail@example.com|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Mark B Geyer, MD 646-608-3745 firstname.lastname@example.org|
|Principal Investigator:||Mark B Geyer, MD||Memorial Sloan Kettering Cancer Center|