Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Uterine Cervical Neoplasms

Melanoma

Squamous Cell Carcinoma of Head and Neck

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Glandular and Epithelial

Head and Neck Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Interleukin-12

Escalating doses of RPTR-168 as a monotherapy in HPV-16 E6/E7 positive tumors and melanoma.

Escalating doses of RPTR-168 as a monotherapy

RPTR-168

David Spriggs, MD

The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6/E7 positive tumors (HNSCC, cervical) and melanoma.

This is a phase 1/2, open-label, first-in-human, multi-center study to characterize the safety and tolerability of RPTR-168 administered i.v. as a monotherapy in patients with relapsed/refractory metastatic or locally-advanced HPV-16 E6/E7 positive tumors and melanoma.

The study will include 2 dosing periods: A Dose Escalation (Phase 1) followed by an Expansion (Phase 2).

RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma

A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of RPTR-168 in Patients With Relapsed/Refractory HPV-16 E6/E7 Positive Tumors and Melanoma

Safety of RPTR-168:1 as a monotherapy in patients with melanoma

Safety of RPTR-168:2 as a monotherapy in patients with HPV-16 E6/E7 positive tumors

Tolerability of RPTR-168:1 as a monotherapy in patients with melanoma

Tolerability of RPTR-168:2 as a monotherapy in patients with HPV-16 E6/E7 positive tumors

Area under the serum concentration-time curve

Number of subject with anti-RPTR-168 antibodies

Repertoire Immune Medicines

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Antirheumatic Agents

Anti-Infective Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Aldesleukin

Immunomodulating Agents

Atezolizumab

Interleukin-2

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Antiviral Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
* Infusion of the IMA101 T-cell product(s)
* Post-infusion administration of low-dose recombinant human interleukin-2

* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
* Infusion of the IMA101 T-cell product(s)
* Post-infusion administration of low-dose recombinant human interleukin-2
* Treatment with atezolizumab every 3 weeks after IMA101 product infusion, for 1 year

IMA101 product

Recombinant human interleukin-2

IMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.

IMADetect

Atezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.

Cedrik Britten, M.D.

The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets.

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) and the main biomarkers screening. If the patient is eligible, white blood cells will be collected with a leukapheresis for the manufacture of the IMA101 product.

MANUFACTURE: IMA101 product will be made from the patient's white blood cells.

TREATMENT: IMA101 product will be administered to the patient intravenously after lymphodepleting pre-conditioning with chemotherapy (fludarabine and cyclophosphamide).

Low-dose IL-2 will be self-administered twice daily for a total of 28 doses after infusion of IMA101 product. In Cohort 2, atezolizumab will be administered every 3 weeks, starting no earlier than 3 weeks after the IMA101 product infusion and after hematologic recovery.

Patients will be monitored closely throughout the study.

ACTolog in Patients With Solid Cancers

Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T Cells (ACTolog® IMA101) Alone or in Combination With Atezolizumab in Patients With Relapsed and/or Refractory Solid Cancers

M.D. Anderson Cancer Center

Immatics US, Inc.

Symptoms and General Pathology

Recurrence

* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
* One dose of IMA201 product will be infused intravenously. Up to four dose levels will be evaluated. At least two patients per cohort will be treated.
* Post-infusion of IMA201 product, administration of low-dose recombinant human interleukin-2

The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.

IMA201 Product

IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.

IMADetect®

Cedrik Britten, MD, PhD

The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the biomarkers screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA201 product.

MANUFACTURING: IMA201 product will be made from the patient's white blood cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA201 infusion to improve the duration of time that IMA201 stays in the body.

After IMA201 infusion, a low dose of IL-2 will be given twice daily for a period of time.

Patients will be closely monitored for safety and for a total of 3 years post IMA201 infusion.

TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)

Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Recurrent and/or Refractory Solid Tumors (ACTengine® IMA201-101)

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Hematologic Neoplasms

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Participants will be randomly assigned, and stratified by disease, to the PEACE Group.

* Participants will meet with palliative care (PC) clinician within 1 week of T-cell collection and within 72 hours of hospital admission for ACT.
* Participants will meet with PC clinician at least 2 x weekly during hospitalization.
* PC clinician will follow participants up to one year after randomization (or enrollment for the open pilot) and will meet participant at least 2 x weekly during inpatient hospitalizations.
* Participants will complete follow-up study assessments on pre-determined days per protocol. The assessments will be filled out remotely or via paper.
* Participants will complete exit interviews in the open pilot only.

Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT.

* Palliative care (PC) intervention tailored to ACT recipients and addressing multiple PC domains with the input of ACT clinical experts, PC clinicians, and patients and caregivers.
* Domains discussed include therapeutic relationship, symptom management, prognostic awareness and illness understanding, coping with illness, treatment decision-making, EOL care.
* The palliative care intervention will be refined for the randomized control trial based on the feedback from the open pilot.

Palliative Care

Standard care for ACT per the treating team.

Usual Care

Patrick C Johnson

Patrick C Johnson, MD

The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups.

The names of the study intervention groups involved in this study are:

* Palliative care (PEACE) plus usual oncology care
* Usual care (standard oncology care)

Participation in this research study is expected to last for up to 2 years.

It is expected that about 90 people will take part in this research study.

This is a single-center, parallel-group, randomized controlled study to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT).

10 participants with planned ACT will be enrolled into an open pilot and will receive a palliative care intervention (PEACE) for the duration of treatment. Once the palliative care intervention has been refined by feedback from the pilot participants, the study will enroll 80 participants and will randomly assign the participants into one of two study intervention groups. Randomization means that a participant is put into a group by chance.

The names of the study intervention groups involved in this study are:

* Palliative care intervention (PEACE) plus usual oncology care
* Usual care (standard oncology care)

Participation in this research study is expected to last for up to 2 years.

It is expected that about 90 people will take part in this research study.

The American Society of Clinical Oncology is supporting this research study by providing funding support.

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Defined as at least 60% of eligible participants enrolling in the study, and among those enrolled and randomized to PEACE, 80% receiving PEACE as intended.

Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores \>=20.

Defined by Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item questionnaire that assesses cancer domains of physical well-being, social/family well-being, and emotional and functional well-being.

Assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), which is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)

Defined by Post-Traumatic Stress Disorder Checklist (PCL), comprised of 17 items that corresponds to key symptoms of PTSD.

Defined by Edmonton Symptom Assessment (ESAS-R), which is a 10-item measure to assess symptoms relevant to patients undergoing adoptive cellular therapy

Defined by Brief COPE which is comprised of 14 items that assesses the degree to which a participant utilizes specific coping strategies.

Defined by Perception of Treatment and Prognosis (PTPQ), a survey that assesses participant understanding of illness and prognosis.

Defined by PTPQ, a survey that assesses participant understanding of illness and prognosis and includes an item on patient-reported end-of-life communication.

Conquer Cancer Foundation

Massachusetts General Hospital

Principal Investigator

Disease Attributes

* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
* One dose of IMA202 product will be infused intravenously. Four dose levels will be evaluated. At least two patients per cohort will be treated.
* Post-infusion of IMA202 product, administration of low dose recombinant human interleukin-2

IMA202 Product

IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials. IMADetect® is intended for investigational use only.

Cedrik Britten, MD

The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA202 product.

MANUFACTURING: IMA202 product will be made from the patient's white blood cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA202 product infusion to improve the duration of time that IMA202 product stays in the body. The patient will be admitted to the hospital during the treatment.

After the IMA202 product infusion, a low dose of IL-2 will be given twice daily for a period of time.

Patients will be closely monitored for safety and for a total of 3 years post IMA202 infusion.

TCR-engineered T Cells in Solid Tumors: IMA202-101

Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Recurrent and/or Refractory Solid Tumors(ACTengine® IMA202-101)

Nervous System Diseases

Glioma

Diffuse Intrinsic Pontine Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Stem Neoplasms

Infratentorial Neoplasms

Patients with DIPG for whom CAR T cells will be delivered into the ventricular system

Interventions:

Biological: Autologous B7H3-specific chimeric antigen receptor (CAR) T cell with additional of IL-7Ra signaling domain Dose level: 1x10e7 CAR T cell, 3x10e7 CAR T cell, 10x10e7 CAR T cell

Autologous T cells lentivirally transduced to express a B7H3 specific chimeric antigen receptor (CAR) with additional of IL-7 receptor alpha signalingdomain given via indwelling central nervous system (CNS) catheter

B7H3 specific CAR T cell with IL-7Ra signaling domain

Piti Techavichit Associate Professor, MD

Koramit Suppipat, MD

Kanhatai Chiengthong, MD

Supannikar Tawinwung, PhD

A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cell with IL-7Ra signal targeting B7H3 in children with diffuse intrinsic pontine glioma (DIPG) patients after complete standard treatments.

The brain tumor known as Diffuse Intrinsic Pontine Glioma is commonly found in children aged between 5 to 10 years. This type of tumor is aggressive and infiltrates the structures of the brain stem. Treatment options are limited due to the location of the tumor, making it impossible to surgically remove the mass like other brain cancers. The standard treatment for this type of tumor is radiation therapy, as this type of cancer does not respond to chemotherapy or currently available targeted drugs. However, radiation therapy has been found to be ineffective and does not improve survival rates.

Currently, there is development in cancer treatment using immunotherapy, where the patient's immune cells are genetically modified to target the cancer, also known as CAR T cells, for the treatment of recurrent or refractory cancers in solid tumors and brain cancers. The research project aims to study the efficacy and safety of treating patients with pontine glioma using T cells that are antigen-specific and have signals from the interleukin-7 receptor alpha and are specific to the B7H3 antigen on the tumor surface. This research is the first of its kind in Thai patients. The research project expects that this treatment will be highly safe and effective in controlling diffuse pontine glioma.

Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG

Safety and Efficacy of Intraventricular Infusion of B7H3 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell in Diffuse Intrinsic Pontine Glioma

The persistence and distribution of B7H3-IL7Ra CAR T cells in the CSF and peripheral blood of diffuse intrinsic pontine glioma patients will be measured by flow cytometry.

Serum cytokine level measurement before and after B7-H3-IL7Ra CAR T-cell infusion.

The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

The overall response rate will be assessed using radiologic response criteria that use the standard sum of the two longest 2D perpendicular diameters to distinguish stable disease, progressive disease (\>25% increase), partial response (\>50% decrease), and complete response (no evaluable or measurable disease).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma	NCT04762225	Head and Neck S... Melanoma Cervical Cancer	RPTR-168	18 Years -	Repertoire Immune Medicines
ACTolog in Patients With Solid Cancers	NCT02876510	Cancer Solid Tumor	Fludarabine Cyclophosphamid... IMA101 product Recombinant hum... IMADetect Atezolizumab	18 Years - 65 Years	Immatics US, Inc.
TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)	NCT03247309	Solid Tumor Cancer Recurrent Solid... Refractory Soli...	IMA201 Product IMADetect®	18 Years -	Immatics US, Inc.
Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy	NCT05646576	Hematologic Mal... Blood Cancer Lymphoma Leukemia Multiple Myelom...	Palliative Care Usual Care	18 Years -	Massachusetts General Hospital
RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma	NCT04762225	Head and Neck S... Melanoma Cervical Cancer	RPTR-168	18 Years -	Repertoire Immune Medicines
TCR-engineered T Cells in Solid Tumors: IMA202-101	NCT03441100	Solid Tumor, Ad... Refractory Canc... Recurrent Cance... Cancer	IMA202 Product IMADetect®	18 Years -	Immatics US, Inc.
RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma	NCT04762225	Head and Neck S... Melanoma Cervical Cancer	RPTR-168	18 Years -	Repertoire Immune Medicines
Safety and Efficacy of Loco-regional B7H3 IL-7Ra CAR T Cell in DIPG	NCT06221553	DIPG Brain Tumo... Diffuse Intrins...	B7H3 specific C...	1 Year - 18 Years	Chulalongkorn University

Spots Global Cancer Trial Database for adoptive cellular therapy