Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10\^7 cells/dose, Dose Level 2: 3x10\^8 cells/dose, Dose Level 3: 9x10\^8 cells/dose with a Dose Level -1: 3x10\^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).

FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.

FT596

Rituximab 375 mg/m\^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion

Dr.Veronika Bachanova, MD, PhD

This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.

This study uses a single dose of the investigational product FT596 in the early post-transplant period. Rituximab or an FDA approved by biosimilar including Rituxan®, Truxima®, and Ruxience™ is given 48 to 72 hours prior to FT596. The goal of this study is to 1) establish a maximum tolerated dose (MTD) of FT596 when given 30 days after transplant and 2) to confirm the MTD and safety of giving a single dose of FT596 at Day 7 post-transplant starting at one dose level below the MTD identified at Day 30.

Patients are enrolled in cohorts of 3 starting at Dose Level 1. There are three dose escalating doses of FT596. A minimum of 28 days will separate each cohort. For Dose Level 1 a minimum of 28 days will separate each patient to assess for dose limiting toxicity (DLT). In subsequent cohorts, the 1st and 2nd patient will be separated by at least 28 days and at least 14 days will separate the 2nd and 3rd patient.

Each new cohort of three patients will be sequentially assigned to the most appropriate dose based on the updated toxicity probabilities under the continuous reassessment method (CRM), and the MTD will be identified when the total sample size of 18 is exhausted or 6 patients are sequentially enrolled at the same dose.

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma

The component I design (FT596 on day 30) will continue until the MTD is declared or until the first dose is declared to be above MTD. The component I dose limiting toxicity (DLT) is defined as any of the following events within 28 days after the FT596 dosing based on CTCAE v5:Grade 4 hematologic toxicity lasting \> 7 days ,Grade 4 non-hematologic toxicity ,Grade ≥3 Infusion Related Reaction, Grade 2 acute GVHD that requires steroid therapy \>7 days or progression after 3 days of steroids or has partial response after 14 days of treatment, Grade ≥3 acute GVHD, Grade 4 cytokine release syndrome (CRS), Grade 3 CRS that does not resolve to \< Grade 2 in 72 hours, Grade 3 neurotoxicity, Grade 3 organ toxicity involving vital organs, Any Grade 3 non-hematological toxicity that does not resolve to ≤Grade 2 within 72 hours

Number of participants experiencing adverse events related to FT596 post auto-HSCT in combination with rituximab

Number of participants experiencing progression or relapse at 12 months post auto HSCT

Number of participants experiencing non-relapse mortality at 100 days post auto-HSCT.

Number of participants experiencing non-relapse mortality at one year post auto-HSCT.

Masonic Cancer Center, University of Minnesota

Symptoms and General Pathology

Heart and Blood Diseases

Mouth and Tooth Diseases

Digestive System Diseases

Necrosis

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Stomatitis

Mucositis

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Part 1, MIT-001 5 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5\~1 hr.

5 subject were enrolled sequentially.

Part 1, MIT-001 10 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5\~1 hr.

6 subjects were enrolled sequentially.

Part 1, MIT-001 20 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5\~1 hr.

5 subjects were enrolled sequentially.

Part 1, MIT-001 30 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5\~1 hr.

It was optional but did not ptoceed according to Steering committee's decision because low level of MIT-001 is enough to show the efficacy and safety of MIT-001.

Part 2, MIT-001 low dose, once a day IV administration for 30 minutes before conditioning regimen administration 0.5\~1 hr.

15 subject will be enrolled parallelly.

Part 2, MIT-001 high dose, once a day IV administration for 30 minutes before conditioning regimen administration 0.5\~1 hr.

15 subject will be enrolled parallelly.

Part 2, placebo(normal saline), once a day IV administration for 30 minutes before conditioning regimen administration 0.5\~1 hr.

15 subject will be enrolled parallelly.

Corresponding dose of MIT-001 IV injection during 0.5\~1hr

MIT-001

normal saline

Seok-Goo Cho, MD, PhD

Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).

In Part 1, it was to determine Recommended Part 2 Dose(RP2D) the prevention effect of MIT-001 in combination with conditioning regimen in autologous hematopoietic stem cell transplantation(auto-HSCT) and to evaluate the pharmacokinetic characteristics of MIT-001.

In Part 2, it's to determine the optimal dose of MIT-001 in combination with conditioning regimen in auto-HSCT.

This clinical trial consists of a 28-days of screening period, 4 to 9 days of conditioning chemotherapy with MIT-001 treatment, auto-HSCT and a 14-days of follow-up and recovery period.

MIT-001 group consists of 5 mg (group 1), 10 mg (group 2), and 20mg (group 3), and the subject will be assigned to from 5 mg of MIT-001 sequentially.

After completion of MIT-001 administration from all 3 MIT-001 groups, Steering Committee (SC) was convened and reviewed the safety and efficacy to determine one of the followings.

* Determine whether the next dose (Group 4: 30 mg) in Part 1: It was not proceeded.
* Determine the RP2D to enter Part 2 phase: 5mg as low dose, 20mg as high dose for Part 2 The investigators will continuously monitor the safety of MIT-001, and can request the steering committee call at any time, and can be carefully reviewed the data such as safety and efficacy.

In Part 2, the subjects are randomly assigned to either one of MIT-001 treatment groups (high-dose, low-dose among RP2D) and placebo at a ratio of 1: 1: 1. If two or more conditioning regimen are determined, conditioning regimen can be considered the stratification factor. Subject will be randomly assigned to either group in blinded method.

Part 1 was completed with 16 patients and open label design to to evaluate the pharmacokinetic characteristics, efficacy, and safety of MIT-001 on prevention effect of MIT-001 in combination with conditioning regimen in auto-HSCT. 5mg as low dose and 20mg as high dose of MIT-001 were determined as RP2D through steering comittee and optional group of 30mg was not needed at Part 1 because low level of MIT-001 was enough to show efficacy and safety of MIT-001.

In Part 2, it's to determine the optimal dose (recommended part 2 dose (RP2D)) of MIT-001 in combination with conditioning regimen in auto-HSCT.

Part I: open label

Part II: double blind, randomized, and Placebo controlled

Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

A Phase IIa, Multi-center, Dose-finding Study to Evaluate Safety and Efficacy for Prevention of Oral Mucositis and PK of MIT-001 in Patients With Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Auto HSCT

The number and incidence rate of AEs will be investigated.

* achievement of ANC \> 0.5x10\^9/L for three consecutive days
* achievement of peripheral platelet \> 20 X 10\^9/L for three consecutive days

OM is evaluated using the World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.

SOM is defined as a WHO score of greater than or equal to 3.

OM grading scale

Grade 0 = Normal

Grade 1 = Erythema and Soreness

Grade 2 = Ulceration but can eat solid foods

Grade 3 = Ulceration,diet limited to liquid (due to mucositis)

Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)

① Grade 1 or higher, ② Grade 2 or higher, ③ Grade 4 or higher

OM grading scale

Grade 0 = Normal

Grade 1 = Erythema and Soreness

Grade 2 = Ulceration but can eat solid foods

Grade 3 = Ulceration,diet limited to liquid (due to mucositis)

Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)

① Grade 1 ② Grade 2 ③ Grade 3 ④ Grade 4

OM grading scale

Grade 0 = Normal

Grade 1 = Erythema and Soreness

Grade 2 = Ulceration but can eat solid foods

Grade 3 = Ulceration,diet limited to liquid (due to mucositis)

Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)

The average grade of each point

OM grading scale

Grade 0 = Normal

Grade 1 = Erythema and Soreness

Grade 2 = Ulceration but can eat solid foods

Grade 3 = Ulceration,diet limited to liquid (due to mucositis)

Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)

① Grade 2 or higher, ② Grade 3 or higher, ③ Grade 4 or higher

OM grading scale

Grade 0 = Normal

Grade 1 = Erythema and Soreness

Grade 2 = Ulceration but can eat solid foods

Grade 3 = Ulceration,diet limited to liquid (due to mucositis)

Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)

① Grade 1 or higher, ② Grade 2 or higher, ③ Grade 3 or higher, ④ Grade 4 or higher

Grade 0 = Normal

Grade 1 = Asymptomatic or mild symptoms; intervention not indicated

Grade 2 = Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated

Grade 3 = Severe pain; interfering with oral intake

Grade 4 = Life-threatening consequences; urgent intervention indicated

Grade 5 = Death

The average grade of each point

Grade 0 = Normal

Grade 1 = Asymptomatic or mild symptoms; intervention not indicated

Grade 2 = Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated

Grade 3 = Severe pain; interfering with oral intake

Grade 4 = Life-threatening consequences; urgent intervention indicated

Grade 5 = Death

Q1: General health condition scale: 0(worst possible) to 10(perfect health)

Q2: Mouth and throat pain: 0(no soreness) to 4(extreme soreness)

Q3: Salvia swallowing, drinking water, eat rice, speaking ans sleeping: 0(no soreness) to 4(extreme soreness)

Q4: General mouth and throat pain: 0(no soreness) to 10(worst possible)

The proportion of patients who used opioid analgesics up to 14 days after the end of therapy.

It will be calculated as morphine equivalents dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL	NCT04555811	NHL Non Hodgkin Lym... Diffuse Large B... High-grade B-ce...	FT596 Rituximab	18 Years -	Masonic Cancer Center, University of Minnesota
Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT	NCT05493800	Oral Mucositis Lymphoma Multiple Myelom... Hematologic Can...	MIT-001 normal saline	19 Years - 70 Years	MitoImmune Therapeutics

Spots Global Cancer Trial Database for auto hsct

Every month we try and update this database with for auto hsct 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 auto hsct

Every month we try and update this database with for auto hsct 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 auto hsct 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.