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Antithymocyte Globulin

Phase 1

Hematologic Malignancies | Small molecule | Oncology |Fate Therapeutics, Inc.|Last Updated: Oct 8, 2013

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Antithymocyte Globulin · 1 trial · 2 indications

Phase 1 1
NCT00890500Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.Hematologic Malignancies
COMPLETED12 Analytics
PHASE1COMPLETED
Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.
Hematologic MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the safety of ProHema modulated umbilical cord blood units when used for transplantation in a reduced intensity, sequential umbilical cord blood transplantation model.
2 years

Secondary Endpoints

Time to engraftment of umbilical cord blood units
2 years
Fractional chimerism of transplanted cord blood units
2 years
Rates of acute and chronic GVHD
2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1ACTIVE_COMPARATOR2 umbilical cord units: Second cord blood unit modulated with ProHema
Group 2ACTIVE_COMPARATOR2 umbilical cord units: First cord blood unit modulated with ProHema

Interventions

NameTypeDescription
FludarabineDRUG30mg/m2/day IV x 6 days
MelphalanDRUG100 mg/m2/day IV x 1 day
Antithymocyte GlobulinDRUG1mg/kg/day x 4 days
SirolimusDRUGGVHD Prophylaxis: Target range 3-12 ng/ml
TacrolimusDRUGGVHD Prophylaxis: Target range 5-10 ng/ml
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate * Patient must be ineligible for traditional myeloablative transplantation according to treating physician * Lack of 6/6 or 5/6 HLA-matched related, 8/8 HLA-ma...

Countries:United States
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Frequently asked questions about Antithymocyte Globulin

What is Antithymocyte Globulin used for?

Antithymocyte Globulin is being investigated for use in hematologic malignancies, specifically in the context of allogeneic stem cell transplantation. It is being studied as part of a therapy involving ProHema modulated umbilical cord blood units in subjects with these conditions.

Who is developing Antithymocyte Globulin?

Antithymocyte Globulin is being developed by Fate Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol FATE on the stock market.

What phase is Antithymocyte Globulin in?

Antithymocyte Globulin is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Antithymocyte Globulin in?

Antithymocyte Globulin has one completed clinical trial, NCT00890500, titled 'Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.' This Phase 1 study enrolled 12 participants in the United States.

What is the modality of Antithymocyte Globulin?

Antithymocyte Globulin is classified as a small molecule therapeutic. It is being studied in the oncology therapeutic area for the treatment of hematologic malignancies.

Was the Antithymocyte Globulin trial randomized or blinded?

The clinical trial for Antithymocyte Globulin, NCT00890500, was not randomized and was not double-blind. It used an active control group, meaning participants received an alternative active treatment rather than a placebo.