A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors

A Phase 1a/1b Dose Escalation and Expansion Trial of PF-0791800 (TTI-621), a Novel Biologic Targeting CD47, in Subjects With Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors

Multicenter, open-label, phase 1a/1b trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor; Hematologic Malignancies
• Intervention / Treatment: Drug: PF-0791800 (TTI-621); Drug: PF-07901800 (TTI-621) plus Rituximab; Drug: PF-07901800 (TTI-621) plus Nivolumab

Detailed Description

This is a trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.

TTI-621 (SIRPαFc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and preventing it from delivering an inhibitory "do not eat" (anti phagocytic) signal to macrophages.

This trial will be conducted in 2 phases and 4 parts: Phase 1a Part 1 (escalation phase) and Phase 1b Parts 2-4 (expansion phase).

In the dose Escalation Phase (phase 1a Part 1), subjects with lymphoma will be enrolled in sequential dose cohorts to receive TTI-621 to characterize safety, tolerability, pharmacokinetics, and the maximum-tolerated dose (MTD).

In the Expansion Phase (phase 1b Parts 2-4), TTI-621 will be given to subjects with a variety of hematologic malignancies and selected solid tumors to further define safety and to characterize efficacy. In the Expansion Phase Part 2, the safety and efficacy of TTI-621 will also be assessed when it is given in combination with other anti-cancer drugs. The dose of TTI-621 to be delivered in the Expansion Phase Parts 2-3 of the study may be increased or decreased based on the subject's tolerability and on the subject's response to treatment.

In the phase 1b dose optimization of the study (Part 4), further dose escalation of TTI-621, beyond the dose determined during phase 1a dose escalation, will be pursued in patients with relapsed and/or refractory CTCL following a 3+3 escalation design and using a revised DLT criteria to further evaluate the safety and tolerability of TTI-621 at dose levels higher than the initially recommended phase 1b Parts 2-3.

Secondary objectives include further characterization of the pharmacokinetics, pharmacodynamics, and development of ADA; and to gain preliminary evidence of the anti-tumor activity of TTI-621 in subjects with a variety of hematologic malignancies and selected solid tumors. In addition, the safety of TTI-621 will be evaluated in combination with other anti-cancer agents.

Pfizer decided terminating this study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • B.C.
    • Vancouver, B.C., Canada, V5Z1H7
      • Fairmont Medical Building, Suite 810
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1H6
      • British Columbia Cancer Agency
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Center
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network - Princess Margaret Cancer Centre
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Duarte, California, United States, 91010
      • City of Hope
    • Palo Alto, California, United States, 94304
      • Freidenrich Center for Translational Research (CTRU)
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Institute
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
    • Denver, Colorado, United States, 80218
      • Presbyterian/St.Luke's Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
  • Indiana
    • Greenfield, Indiana, United States, 46140
      • Covance Biorepository
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack UMC
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health John Theurer Cancer Center
    • Hackensack, New Jersey, United States, 07601
      • The John Theurer Cancer Center at Hackensack UMC
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Cancer Center- Monmouth
  • New York
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Cancer Center Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
    • New York, New York, United States, 10016
      • NYU Investigational Pharmacy
    • New York, New York, United States, 10032
      • Columbia University Medical Center.
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
    • New York, New York, United States, 10016
      • NYU Langone Health (Tisch Hospital)
    • New York, New York, United States, 10017
      • Memorial Sloan Kettering Cancer Center-Clinical Trails Office
    • New York, New York, United States, 10019
      • Columbia Univeristy
    • New York, New York, United States, 10022
      • Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97239
      • Oregon Health and Sciences University
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University-Research Pharmacy Services
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Presbyterian Shadyside
    • Pittsburgh, Pennsylvania, United States, 15237
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute (Pharmacy)
  • Texas
    • Austin, Texas, United States, 78759
      • Myriad RMB Inc
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center, Cancer Prevention Center
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center, Melanoma and Skin Clinic
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98109
      • University of Washington - Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

MAJOR ELIGIBILITY CRITERIA:

Phase 1a Escalation

• Histologically documented, measurable, advanced lymphomas, transfusion-independence

Phase 1b Expansion (Part 2 and 3) • Advanced malignancy: IBCL, ABCL, cHL, AML, ALL, MDS, MPN, SCLC, PTCL and CTCL; measurable disease who have relapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporeal photochemotherapy (ECP) considered a systemic therapy. Local radiation and topical agents are not systemic therapies.

Phase 1b dose optimization (Part 4)

• Histologically confirmed diagnosis of CTCL (both Mycosis Fungoides and Sezary Syndrome): Failed at least 2 prior systemic therapies for CTCL (Systemic therapy does not include local radiation therapy or topical agents); History of histologically documented diagnosis of CTCL stage IB to IVB

Inclusion Criteria (all subjects):

• Advanced measurable malignancy with previously progressed on, or currently progressing on standard anticancer therapy or for whom no other approved conventional therapy exists
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Adequate hematologic, hepatic, renal, and coagulation function; fresh or archived tumor tissue available for immunohistochemistry
• Recovery from prior treatments and/or surgeries; no history of hemolytic anemia or bleeding diathesis.
• AML M3 (French American British, FAB, classification) (i.e., acute promyelocytic leukemia [APL]) excluded

Exclusion Criteria:

• Known current central nervous system disease involvement or untreated brain metastases
• Allogeneic transplant within 30 days prior to the planned start of treatment or subjects with active graft-vs-host disease with the exception of Grade 1 skin involvement
• History of hemolytic anemia or bleeding diathesis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07901800 (TTI-621) Escalation Phase - R/R Lymphoma; The Escalation Phase will include multiple doses of PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Indolent B-Cell Lymphoma; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Aggressive B-Cell Lymphoma; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: T-Cell Lymphoma; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Hodgkin Lymphoma; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Chronic Lymphocytic Leukemia; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Multiple Myeloma; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Acute Myeloid Leukemia; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Myelodysplastic Syndrome; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Myeloproliferative Neoplasms; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Small Cell Lung Cancer; Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Rituximab Combination; Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Rituximab for CD20 positive malignancies	Drug: PF-07901800 (TTI-621) plus Rituximab; Combination therapy; Other Names: TTI-621 plus Rituxan
Experimental: Nivolumab Combination; Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Nivolumab for Hodgkin Lymphoma	Drug: PF-07901800 (TTI-621) plus Nivolumab; Combination therapy; Other Names: TTI-621 plus Opdivo
Experimental: Cutaneous T-Cell Lymphoma (CTCL); Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Peripheral T-Cell Lymphoma (PTCL); Monotherapy expansion cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)
Experimental: Part 4: Cutaneous T-Cell Lymphoma (CTCL); Monotherapy expansion Part 4 (Dose Optimization) cohort with PF-07901800 (TTI-621)	Drug: PF-0791800 (TTI-621); Monotherapy; Other Names: TTI-621 (SIRPα-IgG1 Fc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a Dose Escalation (Part 1) - Dose Limiting Toxicity (DLT) (incidence and severity of AEs)	To characterize the safety profile and DLT per predefined set of AEs related to PF-07901800 (TTI-621) in order to identify the MTD and/or the optimal dose in adult subjects with advanced relapsed or refractory lymphomas.	During the first 3 weeks of treatment/21-day DLT observation period
Phase 1b Expansion (Part 2 and 3) - incidence and severity of AEs	To further characterize the safety of PF-07901800 (TTI-621) in an expanded number of primary hematologic malignancies and selected solid tumors, and to evaluate the safety of individual subject TTI-621 dose intensification. Type and severity (severity according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03).	Time from the date of first dose of study intervention through 30 days after last dose of study intervention (assessed up to approximately 12 months, and Entire cohort for 35 months)
Phase 1b Dose Optimization (Part 4) - Dose Limiting Toxicity (DLT)	Dose optimization phase in subjects with R/R CTCL, to further evaluate the safety and tolerability of PF-07901800 (TTI-621) at dose levels higher than the initially recommended phase 1b dose (as determined during phase 1a dose escalation) and the MTD and/or recommended phase 2 dose per revised DLT criteria following a 3+3 dose escalation schema starting from the highest dose during phase 1b dose expansion following dose intensification regimens permissible per Part 2 and Part 3	During the first 3 weeks of treatment/21-day DLT observation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a Escalation (Part 1) - Pharmacokinetics (PK): Maximum Serum Concentration [Cmax] of PF-07901800	In subjects with R/R lymphoma: Pharmacokinetics: Cmax: serum concentration at the end of study drug infusion	Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 and/or Week 6/8
Phase 1a Escalation (Part 1) - Pharmacokinetics (PK): Area Under the Curve [AUC] from time 0 to 168 hours of PF-07901800	In subjects with R/R lymphoma: Pharmacokinetics: AUC 0-168h: Area Under the Curve from time 0 to 168 hours post study drug administration	Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 and/or Week 6/8
Phase 1a Escalation (Part-1) - Pharmacodynamics (PD): Peripheral CD47 Receptor Occupancy	In patients with R/R Lymphoma: pharmacodynamics: CD47 receptor occupancy on peripheral blood CD3+ cells Measurement unit: %	Week 1 end of infusion (EOI) and/or additional post dose time point(s)
Phase 1a Escalation (Part 1) - Incidence of Anti-Drug Antibody (ADA) against PF-07901800	In patients with R/R Lymphoma: To evaluate the development of immunogenicity (immune response) against of PF-07901800 (TTI-621) - The percentage of participants with positive ADA and neutralizing antibodies.	Week 1, 8, Day 1 and EOT (assessed up to approximately 36 months)
Phase 1b Escalation (Parts 2 and 3) - Pharmacokinetics (PK): Maximum Serum Concentration [Cmax] of PF-07901800	In subjects with various hematological malignancies and selected solid tumors: Pharmacokinetics: Cmax: serum concentration at the end of study drug infusion	Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 and/or Week 6/8
Phase 1b Escalation (Parts 2 and 3) - Pharmacokinetics (PK): Area Under the Curve [AUC] from time 0 to 168 hours of PF-07901800	In subjects with various hematological malignancies and selected solid tumors: Pharmacokinetics: AUC 0-168h: Area Under the Curve from time 0 to 168 hours post study drug administration	Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 and/or Week 6/8
Phase 1b Escalation (Parts 2 and 3) - Pharmacodynamics (PD): Peripheral CD47 Receptor Occupancy	In patients with various hematological malignancies and selected solid tumors: pharmacodynamics: CD47 receptor occupancy on peripheral blood CD3+ cells Measurement unit: %	Week 1 end of infusion (EOI) and/or additional post dose time point(s)
Phase 1b Escalation (Parts 2 and 3) - Incidence of Anti-Drug Antibody (ADA) against PF-07901800	In patients with various hematological malignancies and selected solid tumors: To evaluate the development of immunogenicity (immune response) against of PF-07901800 (TTI-621) - The percentage of participants with positive ADA and neutralizing antibodies.	Week 1, 8, Day 1 and EOT (assessed up to approximately 36 months)
Phase 1b Expansion (Part 2 and 3) - Overall Response Rate (ORR)	In the subjects with various hematological malignancies and selected solid tumors, assess the Organ System Overall Response Rate per respective criteria by each tumor type. OR defined as complete response or partial response	Response assessments performed at the end of indicated weeks from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 12 months)
Phase 1b Expansion (Part 2 and 3) - Duration of Response (DOR)	Various hematological malignancies and selected solid tumors response assessment per respective criteria by each tumor type. OR defined as complete response or partial response	Time from the first documentation of response until disease progression or death due to any cause, whichever occurs first (assessed up to approximately 12 months)
Phase 1b Expansion (Part 2 and 3) - Progression-free Survival (PFS)	In the subjects with various hematological malignancies and selected solid tumors, the PFS assessment by respective criteria of each tumor	Time from the date of first dose of study intervention until PD, or death due to any cause, whichever occurs first (assessed up to approximately 12 months)
Phase 1b Expansion (Part 3) - Part 3: CTCL: organ system overall response rate	In the subjects with CTCL, assess the Organ System Overall Response Rate per Olsen 2011 criteria for CTCL. OR defined as complete response (CR) or partial response (PR).	Response assessments performed at the end of indicated weeks from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 12 months)
Phase 1b Expansion (Part 3) - Part 3: PTCL: organ system overall response rate	In the subjects with PTCL, assess the Organ System Overall Response Rate per Lugano 2014 for PTCL. OR defined as complete response (CR) or partial response (PR).	Response assessments performed at the end of indicated weeks from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 12 months)
Phase 1b Dose Expansion (Dosing Optimization, Part 4) - Pharmacokinetics (PK): Maximum Serum Concentration [Cmax] of PF-07901800	In subjects with R/R CTCL: Pharmacokinetics: Cmax: serum concentration at the end of study drug infusion	Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 and/or Week 6/8
Phase 1b Dose Expansion (Dosing Optimization, Part 4) - Pharmacokinetics (PK): Area Under the Curve [AUC] from time 0 to 168 hours of PF-07901800	In subjects with R/R CTCL: Pharmacokinetics: AUC 0-168h: Area Under the Curve from time 0 to 168 hours post study drug administration	Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 and/or Week 6/8
Phase 1b Dose Expansion (Dosing Optimization, Part 4) - Pharmacodynamics (PD): Peripheral CD47 Receptor Occupancy	In patients with R/R CTCL: pharmacodynamics: CD47 receptor occupancy on peripheral blood CD3+ cells Measurement unit: %	Week 1 end of infusion (EOI) and/or additional post dose time point(s)
Phase 1b Dose Expansion (Dosing Optimization, Part 4) - Incidence of Anti-Drug Antibody (ADA) against PF-07901800	In patients with R/R CTCL: To evaluate the development of immunogenicity (immune response) against of PF-07901800 (TTI-621) - The percentage of participants with positive ADA and neutralizing antibodies.	Week 1, 8, Day 1 and EOT (assessed up to approximately 36 months)
Phase 1b Dose Expansion (Dosing Optimization, Part 4) - Overall Response Rate (ORR)	In subjects with R/R CTCL - Overall Response Rate per respective criteria by each tumor type. Objective response (OR) defined as complete response or partial response.	Response assessments performed at the end of indicated weeks from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 12 months)
Phase 1b Dose Expansion (Dosing Optimization, Part 4) - Duration of Response (DOR)	In subjects with R/R CTCL, tumors response assessment per respective criteria by each tumor type. Objective Response defined as complete response or partial response.	Time from the first documentation of response until disease progression or death due to any cause, whichever occurs first (assessed up to approximately 12 months)
Phase 1b Dose Expansion (Dosing Optimization, Part 4) - CTCL organ system overall response rate	In subjects with R/R CTCL - organ system overall response rate per Olsen 2011 for CTCL. OR includes CR/PR.	Response assessments performed at the end of indicated weeks from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 12 months)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Ansell SM, Maris MB, Lesokhin AM, Chen RW, Flinn IW, Sawas A, Minden MD, Villa D, Percival MM, Advani AS, Foran JM, Horwitz SM, Mei MG, Zain J, Savage KJ, Querfeld C, Akilov OE, Johnson LDS, Catalano T, Petrova PS, Uger RA, Sievers EL, Milea A, Roberge K, Shou Y, O'Connor OA. Phase I Study of the CD47 Blocker TTI-621 in Patients with Relapsed or Refractory Hematologic Malignancies. Clin Cancer Res. 2021 Apr 15;27(8):2190-2199. doi: 10.1158/1078-0432.CCR-20-3706. Epub 2021 Jan 15.
• Johnson LDS, Banerjee S, Kruglov O, Viller NN, Horwitz SM, Lesokhin A, Zain J, Querfeld C, Chen R, Okada C, Sawas A, O'Connor OA, Sievers EL, Shou Y, Uger RA, Wong M, Akilov OE. Targeting CD47 in Sezary syndrome with SIRPalphaFc. Blood Adv. 2019 Apr 9;3(7):1145-1153. doi: 10.1182/bloodadvances.2018030577.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): November 23, 2022

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimated): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Nivolumab; MPN; Lymphoma; Rituximab; PTCL; MDS; Solid Tumor; MM; CLL; Hodgkin lymphoma; CTCL; Chronic lymphocytic leukemia; Small Cell Lung Cancer; Hematologic Malignancies; T-cell lymphoma; CD47; HL; SCLC; Myelodysplastic syndromes; TTI-621; Myeloproliferative neoplasms; Cutaneous T-Cell Lymphoma; Indolent B-cell lymphoma; Aggressive B-cell lymphoma; PF-07901800; ABCL; IBCL; Peripheral T-cell lymphomas; SIRPα-IgG1 Fc
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Rituximab; Immunoglobulin G
• Other Study ID Numbers: TTI-621-01; C4961001 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.