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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04512716
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • B ALL
  • B-ALL
  • DLBCL
  • DLBCL Activated B-Cell Type
  • DLBCL Germinal Center B-Cell Type
  • DLBCL Unclassifiable
  • DLBCL, Nos Genetic Subtypes
  • Diffuse Large B-cell Lymphoma
  • Dlbcl-Ci
  • HGBL
  • HGBL, Nos

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 131-I Apamistamab — DRUG
    Patients will receive 131-I apamistamab 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.
  • CAR T-cell — BIOLOGICAL
    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).

Study Details

This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.

Key Dates

Start date
Feb 2, 2021
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Mark B Geyer, MD
[email protected]
646-608-3745
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Mark Geyer, MD
646-608-3745

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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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