T-cell LymphomaEarly Phase 1GI-hNeoT-01NCT06224049

Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T

A Early Phase 1 study testing hNeo-T, Cyclophosphamide and Fludarabine in people with T-cell Lymphoma, run by BGI, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Objective: To evaluate the safety and tolerability of hNeo-T injection in patients with relapsed or refractory EBV-positive T-cell lymphoma. Secondary objective: To evaluate the effectiveness of hNeo-T injection, and to evaluate the objective response rate (ORR) and disease control rate (DCR) by Lugano2014 criteria… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: T-cell Lymphoma
What is being tested?: hNeo-T, Cyclophosphamide and Fludarabine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 1 Dec 2023to 30 Jun 2026
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years old, and ≤75 years old, gender is not limited;
Must have histologically or cytologically confirmed T-cell lymphoma with at least one measurable tumor lesion (according to Lugano2014 criteria);
The subject's HLA type is HLA-A0201/1101/2402/0203 (containing at least one of the subtypes, as determined by the test report issued by the central laboratory), and there is at least one healthy donor who is a semi-matching HLA type or more with the subject. At least one of the HLA matching loci is HLA-A0201/1101/2402/0203；
The subject has been previously determined to be EBV positive or has been determined to be EBV positive after testing;
The subject has paraffin-embedded tumor tissue/section or biopsy tumor tissue within 2.5 years (tissue biopsy is recommended for subjects with easy-to-sample tumor lesions and consent to biopsy), and these tissues are qualified by gene sequencing data. And the tumor neoantigen screening qualified;
Disease progression after adequate first-line systemic treatment, or disease progression ≥2 cycles (PD) after first-line or above systemic systemic treatment, or ≥4 cycles without remission (CR or PR). Remarks: The first-line systemic treatment should refer to the latest version of the "Lymphoma Diagnosis and Treatment Guide" issued by China's "Chinese Society of Clinical Oncology".

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Volunteer to participate in clinical studies; I or legal guardian fully understand and know the study and sign the informed consent; Willing to follow and be able to complete all test procedures;
ECOG score ≤1 score;
Have venous access to meet venous blood collection;
The survival time is expected to be ≥6 months;
The subjects are willing to use a reliable method of contraception during treatment and within 3 months after the end of treatment, and the blood pregnancy test of women of childbearing age is negative;
Laboratory test results and vital organ functions meet the following requirements: 1) *HIV antibody negative; No active syphilis infection; Negative antibodies to hepatitis C virus; HBV DNA detection value is lower than the upper limit of normal value; 2) Blood routine: absolute value of neutrophil (ANC) ≥1×10^9/L, platelet count (PLT) ≥75×10^9/L, hemoglobin concentration (HGB) ≥80g/L; 3) Blood biochemistry: glutamic-pyruvic transaminase (ALT) and glutamic-oxalic transaminase (AST) ≤3 times the upper limit of normal (ULN) (ALT and AST≤5 times ULN in liver metastasis subjects); Serum creatinine ≤1.5 ULN; Total bilirubin ≤1.5 ULN, or total bilirubin <3 ULN for subjects with GilbertsSyndrome; 4) Coagulation function: prothrombin time (PT) and International standard ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN (for subjects taking anticoagulant drugs for a long time, the coagulation related indexes can meet the normal value range after medication); 5) Left ventricular ejection fraction (LVEF) ≥50%;
Before administration with Chemotherapy preconditioning: 1) Any chemotherapy, targeted drugs, immune checkpoint inhibitors, other drugs studied in clinical trials, Chinese medicines with anti-tumor indications, and other anti-tumor treatments received have passed the 4-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo, and other events that the investigator has judged to be tolerated); 2) If major surgery is performed within 3 weeks, adverse reactions have recovered to grade 1 or lower.

Who cannot join

Pregnant or lactating women;
People with a history of severe hypersensitivity to the cells used in this study and to any drugs;
Patients with a history of organ transplantation, excluding hematopoietic stem cell transplantation;
History of allogeneic hematopoietic stem cell transplantation; Acute or chronic graft-versus-host disease (GVHD);
Clear central nervous system involvement of lymphoma, including parenchyma, meningeal invasion or spinal cord compression;
Any person with active autoimmune disease or who has a history of autoimmune disease that the investigator has determined to be ineligible for this study, including but not limited to the following diseases: Such as systemic lupus erythematosus, immune-related neuropathy, multiple sclerosis, Guillain-Barre syndrome, myasthenia gravis, connective tissue diseases, inflammatory bowel diseases including Crohn's disease and ulcerative colitis (except for patients with vitiligo, eczema, type I diabetes, rheumatoid arthritis and other joint diseases, sjogren's syndrome and psoriasis controlled with topical drugs);

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Uncontrolled concomitant or infectious diseases, such as acutely active infected persons requiring systemic antibiotic, antiviral or antifungal treatment within 2 weeks prior to enrollment;
Severe impairment of liver or kidney function (liver or kidney therapy but not controllable, biochemical indicators are not yet able to meet the criteria for inclusion in Article 11), or uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or medically poorly controlled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >90mmHg), Or cardiovascular and cerebrovascular diseases of clinical significance (e.g. active), For example, cerebrovascular accident (within 6 months before the signing of the informed consent), myocardial infarction (within 6 months before the signing of the informed consent), unstable angina, congestive heart failure classified by the New York Heart Association (NYHA) as class II or above, severe arrhythmia that cannot be controlled with drugs, and electrocardiogram results showing clinical significance in 3 consecutive times (each interval of at least 5 minutes) The presence of abnormalities determined by the investigator to affect subsequent cell therapy, or mental illness and substance abuse, or any condition that the investigator believes may increase the risk of the subject or interfere with the test results;
Subjects who were scheduled to receive glucocorticoids (prednisone or equivalent dose >10mg/ day) or other immunosuppressants for a condition within 2 weeks prior to lymphocyte clearance preconditioning administration and during the study period were excluded. Remarks: In the absence of active autoimmune disease, prednisone or an equivalent adrenal drug dose ≤10mg/ day is allowed to substitute administration; Subjects were allowed to use topical, ocular, intraarticular, intranasal, and inhaled corticosteroids (with very low systemic absorption);
Subject is scheduled to receive immunomodulatory drugs (such as interferon, GM-CSF, thymosin, gamma globulin, etc.) within 2 weeks before lymphocyte clearance preconditioning administration and during the study period due to certain conditions;
The investigator evaluates that the subject is unable or unwilling to comply with the requirements of the study protocol;
Those with functional defects of genes related to antigen presentation, antigen recognition and cell killing detected by sequencing;
History of other malignant tumors within the past 5 years; Excluding curable basal or squamous cell skin cancer, superficial bladder or prostate carcinoma in situ, cervical carcinoma in situ or breast carcinoma in situ;
The subject has any disease or medical condition that may affect the evaluation of the safety or efficacy of the investigational drug.

Trial locations and contacts

1 site in 1 country.

LiXin Wang, Doctor contact

13718000488

Wanglixin1991@sohu.com

China1 site, 1 recruiting

ShenZhen University General Hospital
Shenzhen, Guangdong, 518000
DiYa Cai, Doctor, 19831362517, sdzyllwyh@126.com
LiXin Wang, Doctor, 13718000488, Wanglixin1991@sohu.com
Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Targeted Haploidentical Neoantigen T Cell Injection (hNeo-T) in the Treatment of Relapsed or Refractory EBV-positive T-cell Lymphoma

Objective: To evaluate the safety and tolerability of hNeo-T injection in patients with relapsed or refractory EBV-positive T-cell lymphoma.

Secondary objective: To evaluate the effectiveness of hNeo-T injection, and to evaluate the objective response rate (ORR) and disease control rate (DCR) by Lugano2014 criteria; Progression-free survival (PFS), duration of response (DOR), and overall survival (OS ) followed.

Objective of the exploratory study: To investigate the in vivo process of hNeo-T injection and describe the activity and related biological functions of hNeo-T cells in vivo, including but not limited to.

Read the detailed description

This is a single arm,open label and non-randomized clinical trial with a planned enrollment of 6-12 participants to evaluate the safety and tolerability of hNeo-T injection, determine dose-limiting toxicity (DLT), explore the maximum tolerated dose (MTD), or the recommended dosage for later clinical studies.

The DLT observation period is 28 days after the infusion of hNeo-T injection. In the first stage, 3 subjects will be enrolled in the experiment of the first dose group (total number of cells is 5×10^7/ bag). If DLT does not appear during the experiment, the study will enter the second stage after safety assessment and analysis, and 3 subjects will be enrolled in the experiment of the second dose group (total number of cells is 1×10^8/ bag) in this stage.

If DLT occurs in one of the 3 subjects , three more subjects will be added to the dose group. If no additional DLT occurs, the study will enter the next dose group; If additional DLT occurs, enrollment in the group will be stopped and the dose will be defined as an intolerable dose; If DLT occurs in two or more of the 3 subjects, enrollment in the dose group will be discontinued and the dose will be defined as an intolerable dose;

After climbing to an intolerable dose, there will be a discussion to decide whether to explore an intermediate dose or to define the dose level as MTD; If MTD is not defined in the high-dose group, the high-dose group will be used as the final climbing dose. If a higher dose will be planned, a follow-up clinical study can only be carried out after evaluation,discussion and consensus.

Conditions: T-cell Lymphoma
Being tested: hNeo-T, Cyclophosphamide, Fludarabine
Keywords: T-cell lymphomas, Epstein-Barr Virus, hNeo-T
Medical subject headings: Lymphoma, T-Cell, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hNeo-TBiological
After subject screening, peripheral blood mononuclear cell （PBMC） donors matching half or more of the subject's HLA matching will undergo blood collection to prepare hNeo-T. hNeo-T preparation is expected to be 25-30 days after blood collection. In this study, the bridging therapy will be allowed before Chemotherapy preconditioning, and the investigators will decide whether to use it. Chemotherapy preconditioning will be performed before hNeo-T transfusion. If the absolute value of lymphocyte (LYM) before pretreatment is <0.8×10^9/L and the subject meets the criteria for cell transfusion, the chemotherapy preconditioning will not be performed and subsequent cell transfusion can be performed directly.
CyclophosphamideDrug
Chemotherapy preconditioning will be performed before hNeo-T transfusion.
FludarabineDrug
Chemotherapy preconditioning will be performed before hNeo-T transfusion

Study groups in NCT06224049
Study group	Role	What they receive
hNeo-T	Experimental	The escalating doses of hNeo-T in this study will be 510^7 cells and110^8 cells. Receives: Biological: hNeo-T; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety assessment (Evaluation of treatment-related adverse events according to CTCAEv5.0)
To determine the incidence of AE and SAE in clinical trials
Measured: The first dose will be administered until 28 days after the last dose

Secondary outcomes (5)

Objective response rate (ORR)
The total number of subjects with complete response (CR) and partial response (PR) confirmed according to Lugano2014 criteria (i.e., CR+PR) and the proportion of subjects in the corresponding analysis set
Measured: Up to 48 weeks
Disease control rate (DCR)
The total number of subjects with CR, PR, and stable disease (SD) confirmed according to Lugano2014 criteria (i.e. CR+PR+SD) and the proportion of subjects in the corresponding analysis set
Measured: Up to 48 weeks
Progression free survival (PFS)
According to the Lugano2014 criteria, the time between the start of cell transfusion and the first recorded date of disease progression (PD) or death. If no disease progression is observed, the deletion date should be the date of the last tumor measurement, and if there is no baseline and/or tumor evaluation after transfusion, the PFS will be deleted to the cell transfusion date. Detailed rules on deletion will be described in the statistical analysis plan.
Measured: Up to 52 weeks
Duration of response (DOR)
According to the Lugano2014 criteria, the time between a subject's first identification with CR or PR and the first recording of PD or the date of death, depending on which occurs first. For subjects who do not experience disease progression after a combined response, the duration of response will be deleted at the last evaluable tumor measurement date.
Measured: Up to 36 weeks
Overall survival (OS)
The time from cell transfusion to death who have completed the prescribed dose. If the subjects is lost to follow-up, the last known date of survival will be OS deletion time.
Measured: Up to 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202330 Jun 2026

First posted25 Jan 2024
Study start1 Dec 2023
Primary completion30 Jun 2025 (estimated)
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for T-cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06224049
Sponsor's protocol ID: BGI-006
Other IDs: KYLLHS-20230102C
Acronym: GI-hNeoT-01
Status last verified: Mar 2024
First submitted: 13 Nov 2023
Last updated: 12 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Comoli P, Basso S, Riva G, Barozzi P, Guido I, Gurrado A, Quartuccio G, Rubert L, Lagreca I, Vallerini D, Forghieri F, Morselli M, Bresciani P, Cuoghi A, Paolini A, Colaci E, Marasca R, Cuneo A, Iughetti L, Trenti T, Narni F, Foa R, Zecca M, Luppi M, Potenza L. BCR-ABL-specific T-cell therapy in Ph+ ALL patients on tyrosine-kinase inhibitors. Blood. 2017 Feb 2;129(5):582-586. doi: 10.1182/blood-2016-07-731091. Epub 2016 Dec 7.
PubMed 27927646
Chen Y, Zhao H, Luo J, Liao Y, Dan X, Hu G, Gu W. A phase I dose-escalation study of neoantigen-activated haploidentical T cell therapy for the treatment of relapsed or refractory peripheral T-cell lymphoma. Front Oncol. 2022 Nov 10;12:944511. doi: 10.3389/fonc.2022.944511. eCollection 2022.
PubMed 36439517
Zacharakis N, Chinnasamy H, Black M, Xu H, Lu YC, Zheng Z, Pasetto A, Langhan M, Shelton T, Prickett T, Gartner J, Jia L, Trebska-McGowan K, Somerville RP, Robbins PF, Rosenberg SA, Goff SL, Feldman SA. Immune recognition of somatic mutations leading to complete durable regression in metastatic breast cancer. Nat Med. 2018 Jun;24(6):724-730. doi: 10.1038/s41591-018-0040-8. Epub 2018 Jun 4.
PubMed 29867227
Keskin DB, Anandappa AJ, Sun J, Tirosh I, Mathewson ND, Li S, Oliveira G, Giobbie-Hurder A, Felt K, Gjini E, Shukla SA, Hu Z, Li L, Le PM, Allesoe RL, Richman AR, Kowalczyk MS, Abdelrahman S, Geduldig JE, Charbonneau S, Pelton K, Iorgulescu JB, Elagina L, Zhang W, Olive O, McCluskey C, Olsen LR, Stevens J, Lane WJ, Salazar AM, Daley H, Wen PY, Chiocca EA, Harden M, Lennon NJ, Gabriel S, Getz G, Lander ES, Regev A, Ritz J, Neuberg D, Rodig SJ, Ligon KL, Suva ML, Wucherpfennig KW, Hacohen N, Fritsch EF, Livak KJ, Ott PA, Wu CJ, Reardon DA. Neoantigen vaccine generates intratumoral T cell responses in phase Ib glioblastoma trial. Nature. 2019 Jan;565(7738):234-239. doi: 10.1038/s41586-018-0792-9. Epub 2018 Dec 19.
PubMed 30568305
Hilf N, Kuttruff-Coqui S, Frenzel K, Bukur V, Stevanovic S, Gouttefangeas C, Platten M, Tabatabai G, Dutoit V, van der Burg SH, Thor Straten P, Martinez-Ricarte F, Ponsati B, Okada H, Lassen U, Admon A, Ottensmeier CH, Ulges A, Kreiter S, von Deimling A, Skardelly M, Migliorini D, Kroep JR, Idorn M, Rodon J, Piro J, Poulsen HS, Shraibman B, McCann K, Mendrzyk R, Lower M, Stieglbauer M, Britten CM, Capper D, Welters MJP, Sahuquillo J, Kiesel K, Derhovanessian E, Rusch E, Bunse L, Song C, Heesch S, Wagner C, Kemmer-Bruck A, Ludwig J, Castle JC, Schoor O, Tadmor AD, Green E, Fritsche J, Meyer M, Pawlowski N, Dorner S, Hoffgaard F, Rossler B, Maurer D, Weinschenk T, Reinhardt C, Huber C, Rammensee HG, Singh-Jasuja H, Sahin U, Dietrich PY, Wick W. Actively personalized vaccination trial for newly diagnosed glioblastoma. Nature. 2019 Jan;565(7738):240-245. doi: 10.1038/s41586-018-0810-y. Epub 2018 Dec 19.
PubMed 30568303

Want to know more?

LiXin Wang, Doctor

13718000488

Wanglixin1991@sohu.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Targeted Haploidentical Neoantigen T Cell Injection (hNeo-T) in the Treatment of Relapsed or Refractory EBV-positive T-cell Lymphoma
ClinicalTrials.gov ID: NCT06224049
Acronym / sponsor ID: GI-hNeoT-01 / BGI-006
Conditions: T-cell Lymphoma
Keywords: T-cell lymphomas, Epstein-Barr Virus, hNeo-T
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 6 participants (estimated)
Lead sponsor: BGI, ChinaUniversity, hospital or other
Collaborators: Shenzhen University General Hospital
Study start: 1 Dec 2023 (actual)
Primary completion: 30 Jun 2025 (estimated)
Study completion: 30 Jun 2026 (estimated)
First posted: 25 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objective: To evaluate the safety and tolerability of hNeo-T injection in patients with relapsed or refractory EBV-positive T-cell lymphoma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
hNeo-T	Experimental	Biological: hNeo-T, Drug: Cyclophosphamide, Drug: FludarabineThe escalating doses of hNeo-T in this study will be 510^7 cells and110^8 cells.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Age ≥18 years old, and ≤75 years old, gender is not limited;
Must have histologically or cytologically confirmed T-cell lymphoma with at least one measurable tumor lesion (according to Lugano2014 criteria);
The subject's HLA type is HLA-A0201/1101/2402/0203 (containing at least one of the subtypes, as determined by the test report issued by the central laboratory), and there is at least one healthy donor who is a semi-matching HLA type or more with the subject. At least one of the HLA matching loci is HLA-A0201/1101/2402/0203；
The subject has been previously determined to be EBV positive or has been determined to be EBV positive after testing;
The subject has paraffin-embedded tumor tissue/section or biopsy tumor tissue within 2.5 years (tissue biopsy is recommended for subjects with easy-to-sample tumor lesions and consent to biopsy), and these tissues are qualified by gene sequencing data. And the tumor neoantigen screening qualified;

Key exclusion criteria (14 listed)

Pregnant or lactating women;
People with a history of severe hypersensitivity to the cells used in this study and to any drugs;
Patients with a history of organ transplantation, excluding hematopoietic stem cell transplantation;
History of allogeneic hematopoietic stem cell transplantation; Acute or chronic graft-versus-host disease (GVHD);
Clear central nervous system involvement of lymphoma, including parenchyma, meningeal invasion or spinal cord compression;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hNeo-TAfter subject screening, peripheral blood mononuclear cell （PBMC） donors matching half or more of the subject's HLA matching will undergo blood collection to prepare hNeo-T. hNeo-T preparation is expected to be 25-30 days after blood collection. In this study, the bridging therapy will be allowed before Chemotherapy preconditioning, and the investigators will decide whether to use it. Chemotherapy preconditioning will be performed before hNeo-T transfusion. If the absolute value of lymphocyte (LYM) before pretreatment is <0.8×10^9/L and the subject meets the criteria for cell transfusion, the chemotherapy preconditioning will not be performed and subsequent cell transfusion can be performed directly.	Biological	hNeo-T
CyclophosphamideChemotherapy preconditioning will be performed before hNeo-T transfusion.	Drug	hNeo-T
FludarabineChemotherapy preconditioning will be performed before hNeo-T transfusion	Drug	hNeo-T

Primary outcome

Safety assessment (Evaluation of treatment-related adverse events according to CTCAEv5.0)
Time frame: The first dose will be administered until 28 days after the last dose
To determine the incidence of AE and SAE in clinical trials

5 secondary outcomes

Objective response rate (ORR)
Time frame: Up to 48 weeks
Disease control rate (DCR)
Time frame: Up to 48 weeks
Progression free survival (PFS)
Time frame: Up to 52 weeks
Duration of response (DOR)
Time frame: Up to 36 weeks
Overall survival (OS)
Time frame: Up to 72 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Background: PubMed 27927646Comoli P, Basso S, Riva G, Barozzi P, Guido I, Gurrado A, Quartuccio G, Rubert L, Lagreca I, Vallerini D, Forghieri F, Morselli M, Bresciani P, Cuoghi A, Paolini A, Colaci E, Marasca R, Cuneo A, Iughetti L, Trenti T, Narni F, Foa R, Zecca M, Luppi M, Potenza L. BCR-ABL-specific T-cell therapy in Ph+ ALL patients on tyrosine-kinase inhibitors. Blood. 2017 Feb 2;129(5):582-586. doi: 10.1182/blood-2016-07-731091. Epub 2016 Dec 7.
Background: PubMed 36439517Chen Y, Zhao H, Luo J, Liao Y, Dan X, Hu G, Gu W. A phase I dose-escalation study of neoantigen-activated haploidentical T cell therapy for the treatment of relapsed or refractory peripheral T-cell lymphoma. Front Oncol. 2022 Nov 10;12:944511. doi: 10.3389/fonc.2022.944511. eCollection 2022.
Background: PubMed 29867227Zacharakis N, Chinnasamy H, Black M, Xu H, Lu YC, Zheng Z, Pasetto A, Langhan M, Shelton T, Prickett T, Gartner J, Jia L, Trebska-McGowan K, Somerville RP, Robbins PF, Rosenberg SA, Goff SL, Feldman SA. Immune recognition of somatic mutations leading to complete durable regression in metastatic breast cancer. Nat Med. 2018 Jun;24(6):724-730. doi: 10.1038/s41591-018-0040-8. Epub 2018 Jun 4.
Background: PubMed 30568305Keskin DB, Anandappa AJ, Sun J, Tirosh I, Mathewson ND, Li S, Oliveira G, Giobbie-Hurder A, Felt K, Gjini E, Shukla SA, Hu Z, Li L, Le PM, Allesoe RL, Richman AR, Kowalczyk MS, Abdelrahman S, Geduldig JE, Charbonneau S, Pelton K, Iorgulescu JB, Elagina L, Zhang W, Olive O, McCluskey C, Olsen LR, Stevens J, Lane WJ, Salazar AM, Daley H, Wen PY, Chiocca EA, Harden M, Lennon NJ, Gabriel S, Getz G, Lander ES, Regev A, Ritz J, Neuberg D, Rodig SJ, Ligon KL, Suva ML, Wucherpfennig KW, Hacohen N, Fritsch EF, Livak KJ, Ott PA, Wu CJ, Reardon DA. Neoantigen vaccine generates intratumoral T cell responses in phase Ib glioblastoma trial. Nature. 2019 Jan;565(7738):234-239. doi: 10.1038/s41586-018-0792-9. Epub 2018 Dec 19.
Background: PubMed 30568303Hilf N, Kuttruff-Coqui S, Frenzel K, Bukur V, Stevanovic S, Gouttefangeas C, Platten M, Tabatabai G, Dutoit V, van der Burg SH, Thor Straten P, Martinez-Ricarte F, Ponsati B, Okada H, Lassen U, Admon A, Ottensmeier CH, Ulges A, Kreiter S, von Deimling A, Skardelly M, Migliorini D, Kroep JR, Idorn M, Rodon J, Piro J, Poulsen HS, Shraibman B, McCann K, Mendrzyk R, Lower M, Stieglbauer M, Britten CM, Capper D, Welters MJP, Sahuquillo J, Kiesel K, Derhovanessian E, Rusch E, Bunse L, Song C, Heesch S, Wagner C, Kemmer-Bruck A, Ludwig J, Castle JC, Schoor O, Tadmor AD, Green E, Fritsche J, Meyer M, Pawlowski N, Dorner S, Hoffgaard F, Rossler B, Maurer D, Weinschenk T, Reinhardt C, Huber C, Rammensee HG, Singh-Jasuja H, Sahin U, Dietrich PY, Wick W. Actively personalized vaccination trial for newly diagnosed glioblastoma. Nature. 2019 Jan;565(7738):240-245. doi: 10.1038/s41586-018-0810-y. Epub 2018 Dec 19.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

LiXin Wang, Doctor contact

13718000488

Wanglixin1991@sohu.com

LiXin Wang, Doctor principal investigator

Shenzhen University General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing hNeo-T, Cyclophosphamide and Fludarabine in people with T-cell Lymphoma, run by BGI, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LiXin Wang, Doctor (13718000488, Wanglixin1991@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety assessment (Evaluation of treatment-related adverse events according to CTCAEv5.0) (time frame: The first dose will be administered until 28 days after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06224049, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.