Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Antimetabolites

Enzyme Inhibitors

IMM01 and Azacitidine in Relapse/Refractory AML

Interventions:

Drug: IMM01 Drug: Azacitidine

IMM01 and Azacitidine in Relapse/Refractory MDS

Interventions:

Drug: IMM01 Drug: Azacitidine

IMM01 and Azacitidine in treatment naive AML

Interventions:

Drug: IMM01 Drug: Azacitidine

IMM01 and Azacitidine in treatment naive MDS and naive CMML

Interventions:

Drug: IMM01 Drug: Azacitidine

IMM01 is intravenously once a week, every 28 days for a treatment cycle;

IMM01

Azacitidine 75 mg/m/ day is administered subcutaneously for 7 consecutive days, with each 28-day treatment cycle planned for 6 treatment cycles

jinhua zhou

yujuan Ma

Ronghua Hu

This trial is an open-lable , multi-center, Phase 1/Phase 2 study that will evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and and immunogenicity of IMM01 combined with Azacitidine in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).

Main study purpose:

* To evaluate the safety and tolerability of IMM01 combined with Azacitidine in patients with AML and MDS.
* To explore the Maximum Tolerated Dose (MTD) of IMM01 combined with Azacitidine, and determine the phase 2 clinical recommended dose (RP2D) of IMM01 combined with Azacitidine.

Secondary study purpose:

* To evaluate the efficacy of IMM01 combined with Azacitidine in patients with AML and MDS.
* To evaluate the Pharmacokinetics and Pharmacodynamics of IMM01 combined with Azacitidine, in patients with AML and MDS.

Exploratory study purpose:

• To evaluate the immunogenicity of IMM01 combined with Azacitidine in patients with AML and MDS.

A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1/Phase 2 Study of IMM01 Combined With Azacitidine in Patients With AML and MDS

To be summarized using descriptive statistics

MTD is the highest dose in patients with DLT incidence \<1/3.For a dose group to be assessed as MTD, at least 6 DLT data must be available to evaluate the subject.

Area under the serum concentration - time curve

Time to peak (maximum) serum concentration

Response determined per European LeukemiaNet response criteria:

CR = bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0 x 10e9/L; platelet count \> 100 x 10e9/L; and independence of red cell transfusions.

CRi = all CR criteria except for residual neutropenia (\< 1.0 x 10e9/L) or thrombocytopenia (\< 100 x 10e9/L)\].

To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).

Response Criteria are according to the Modified IWG (International Working Group) Response Criteria in Myelodysplasia.CR: bone marrow evaluation shows less than or equal to (\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 gram per deciliter (g/dL), neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count \<100 x 10\^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10\^9/L.

Institute of Hematology & Blood Diseases Hospital, China

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Recurrence

Hematologic Neoplasms

The escalation dosing were 3µg/kg, 10µg/kg, 50µg/kg, 150µg/kg, 500µg/kg, 1.0mg/kg, 1.5mg/kg and 2.0mg/kg.

The extend cohorts were Hodgkin's lymphoma, B-cell lymphoma,NK/T-cell lymphoma,AML,MDS and MM cohorts

IMM01 will be administered once a week for 4 weeks.

This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM01 in subjects with refractory or recurrent hematologic malignancy.

IMM01 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle).

The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase.

Once the RP2D is determined, will explore for Classic Hodgkin's lymphoma, B-cell lymphoma,NK/T-cell lymphoma, AML, MDS and MM cohorts.

This is an open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM01 in subjects with relapsed or refractory lymphoma.

Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy

A Phase 1 Clinical Study to Evaluate IMM01 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Refractory or Recurrent Hematologic Malignancy

Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs)

Incidence and characteristics of dose-limiting toxicities (DLTs)

MTD is the highest dose in patients with DLT incidence \<30%.

To evaluate the immunogenicity of IMM01 in patients with refractory or recurrent hematologic malignancy

ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)

DCR is defined as the proportion of participants who have a critical response (CR), partial response (PR) or disease stable (SD)

DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)

Defined as the duration from the start of treatment until tumor progression or death of any cause

Maximum Plasma Concentration observed in patients with IMM01 dosed

time to maximum concentration observed in patients with IMM01 dosed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome	NCT05140811	Acute Myeloid L... Myelodysplastic...	IMM01 Azacitidine	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy	NCT05860075	Hematologic Mal...	IMM01	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Spots Global Cancer Trial Database for imm01

Every month we try and update this database with for imm01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for imm01

Every month we try and update this database with for imm01 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imm01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.