Iomab-ACT

DEVELOPMENT STEP phase-1

SPONSOR MATRIX Actinium Pharmaceuticals [ATNM]

MECHANISM TARGET // UNMAPPED_TARGET

[THERAPEUTIC_PROFILE]

Target Indications

Relapsed/Refractory B-ALL, DLBCL

Mechanism Abstract

A small molecule protein degrader

[CLINICAL_TRIALS_REGISTRY]

TOTAL EXTRACTED2

RECRUITING STATUS2

COMPLETED RUNS0

REGISTRY & PHASE

TESTED CONDITION

STUDY TITLE & LIFECYCLE TIMELINES

STATUS

➔

P-1NCT06768905

Non Hodgkin LymphomaDiffuse Large B Cell Lymphoma

N=30Est. Finish: 2030-05

IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL

recruiting

ENROLLMENT PATIENT CAPACITY30 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2025-04-25(actual)

Primary End:2029-05(estimated)

Study Finish:2030-05(estimated)

OFFICIAL PROTOCOL TITLE

IOMAB-ACT: A Phase Ib/II Multi-institutional Study of 131 I-Apamistamab Followed by CD19-Targeted CAR-T Cell Therapy for Patients With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

[INVESTIGATORS_&_FACILITY_ROSTER]

Farrukh Awan, MD, MS, MBAPRINCIPAL INVESTIGATOR — University of Texas Southwestern Medical Center

Silviya MeletathCONTACT — University of Texas Southwestern Medical Center

[PRIMARY_SUCCESS_ENDPOINTS]

Dose-limiting toxicity (safety) -Part A (safety run-in)

Analysis Window: Start of treatment up to 30 days post CAR T-cell infusion

Complete response (efficacy) -Part B (Cohort expansion)

Analysis Window: Screening visit to Day 100 visit

[SECONDARY_SUCCESS_ENDPOINTS]

Severity of cytokine release syndrome (CRS)

Analysis Window: within 100 days of CAR T-cell infusion

Severity of immune effector cell-associated neurotoxicity (ICANS)

Analysis Window: within 100 days of CAR T-cell infusion

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

Part A (Safety run-in)

EXPERIMENTAL

131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CD-19 CAR-T cell therapy

Part B (cohort expansion)

EXPERIMENTAL

131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CAR-T cell therapy

[DOSING_&_INTERVENTION_SPECIFICITIES]

Iomab-BDRUG

single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion.

CAR-T cellDRUG

CAR-T cell therapy

➔

E-P-1NCT04512716

B-ALLDLBCL+9 more

N=12Est. Finish: 2027-01

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

recruiting

ENROLLMENT PATIENT CAPACITY12 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2021-02-02(actual)

Primary End:2027-01(estimated)

Study Finish:2027-01(estimated)

OFFICIAL PROTOCOL TITLE

[INVESTIGATORS_&_FACILITY_ROSTER]

Mark B Geyer, MDPRINCIPAL INVESTIGATOR — Memorial Sloan Kettering Cancer Center

Mark Geyer, MDCONTACT — Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Somali Gavane, MDCONTACT — Memorial Sloan Kettering Cancer Center

[PRIMARY_SUCCESS_ENDPOINTS]

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

Analysis Window: 30 days after treatment

[SECONDARY_SUCCESS_ENDPOINTS]

// NO_EXPLICIT_SECONDARY_OUTCOMES_DUMPED

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

B-Cell Acute Lymphoblastic Leukemia/Diffuse Large B-Cell Lym

EXPERIMENTAL

Participants will have relapsed or refractory B-Cell Acute Lymphoblastic Leukemia or Diffused Large B-Cell Lymphoma

[DOSING_&_INTERVENTION_SPECIFICITIES]

131-I ApamistamabDRUG

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-cellBIOLOGICAL

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).