ClinicalTrials.gg
Not yet recruitingNCT07809139Updated Sep 9, 2026

A Clinical Study to Evaluate CHT101 Injection in Subjects With Relapsed/Refractory T-Cell and B-Cell Hematologic Malignancies

A Phase 1 interventional study of CHT101 in Hematological Malignancies, sponsored by Nanjing Miracle Biotechnology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Nanjing Miracle Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 148 studies in Hematologic Neoplasms with a site in China — 75 open to participants now, 83 under way, 8 of them phase 3. Hematologic Neoplasms · China.

Planned enrollment
83rd of 123
30 · median 56
Started
2026
with 19 others
Phase 1
57 of 148
30 open now
Primary completion
2028-12
later than 69 of 82 live
Registered
147th of 148
by date

Among the 148 studies in Hematologic Neoplasms with a site in China, this one is the 83rd largest by planned enrollment of the 123 interventional ones that give a count, is one of 20 that started in 2026, is one of 57 in phase 1, reaches primary completion later than 69 of the 82 other live ones, and was the 147th registered.

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

Browse Hematologic Neoplasms studies →

Open to participants now

75 of the 148 studies in Hematologic Neoplasms with a site in China are open now. Recruiting first, the newest first:

70 more — sign in →

All 75 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study summary

Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of anti-CD70 chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies.

Secondary Objectives: To characterize the PK profiles of CHT101; to evaluate the clinical efficacy of CHT101 for CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies.

Indication: CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies

03

Conditions studied

  • Hematological Malignancies

Keywords

  • UCAR-T
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Understand and voluntarily provide written (ICF) prior to any study-related assessments/procedures;
  2. Aged between 18 and 70 years (inclusive) at the time of ICF signing;
  3. CD70-positive tumor cells detected in bone marrow or peripheral blood by flow cytometry, or positive CD70 immunohistochemistry in tumor tissue;
  4. Subjects with T-cell with as defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion identified by imaging (PET-CT or CT) according to Lugano criteria (lymph node lesion with any diameter >1.5 cm; extranodal lesion with any diameter >1.0 cm), and meeting the following criteria: relapsed/refractory peripheral T-cell lymphoma (including but not limited to peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, adult T-cell leukemia/lymphoma) or cutaneous T-cell lymphoma (including but not limited to mycosis fungoides or Sézary syndrome [stage IIB or higher with disease involving two or more regions, or single-region disease with large-cell transformation]), and having received prior systemic therapy: subjects with peripheral T-cell lymphoma shall have received at least one ; subjects with cutaneous T-cell lymphoma shall have received at least two lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin therapy, or relapsed after ≥2 prior therapies (if anaplastic lymphoma kinase-positive);
  5. Subjects with relapsed/refractory B-cell malignancies with at least one measurable lesion and meeting at least one of the following criteria:

    • Indolent lymphoma (FL, MCL, MZL): relapsed or refractory after at least two prior lines of therapy containing a CD20 antibody;
    • Chronic lymphocytic leukemia (CLL): relapsed or refractory after at least two prior lines of therapy including BTK inhibitor and venetoclax;
    • Aggressive or highly aggressive lymphoma (DLBCL, Burkitt lymphoma, high-grade B-cell lymphoma [double-hit, triple-hit, primary mediastinal DLBCL]): relapsed or refractory after at least two prior lines of therapy containing a CD20 antibody and anthracycline, and the subject is ineligible for stem-cell transplantation (conditions for ineligibility for autologous stem-cell transplantation include absence of disease response after salvage therapy, and failure of stem-cell mobilization precluding transplantation);
    • Acute lymphoblastic leukemia (ALL): relapsed or refractory after at least two prior lines of therapy;
  6. Histopathologically confirmed classical Hodgkin lymphoma (cHL), relapsed or refractory (following BV and therapy), with at least one measurable lesion per the Lugano 2014 lymphoma response evaluation criteria;
  7. (ECOG) performance status score of 0 or 1 at the time of ICF signing;
  8. Expected survival of at least 12 weeks;
  9. Fertile male subjects and female subjects of must agree to use effective from the time of ICF signing until 2 years after administration of product. Female subjects of child-bearing potential include pre-menopausal women and women within 2 years . Serum pregnancy test must be negative for female subjects of child-bearing potential at screening.

Exclusion criteria

Exclusion Criteria:

  1. Central nervous system (CNS) , or metastatic central compression; or prior history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc.;
  2. History of organ transplantation;
  3. History of other primary within 5 years prior to study treatment, except for: a) adequately treated and cured carcinoma in situ of the cervix; b) localized basal-cell carcinoma or squamous-cell carcinoma of the skin;
  4. Subjects with positive in peripheral blood at screening; subjects positive for virus (HCV) antibody with detectable peripheral blood HCV RNA; subjects positive for (HIV) antibody; subjects with both positive treponemal-specific antibody and non-treponemal antibody tests for syphilis;
  5. Known allergy to any component of study medications, including but not limited to lymphodepleting agents (cyclophosphamide, fludarabine), contrast media for imaging examinations;
  6. Prior anti-CD70 antitumor therapy, including but not limited to anti-CD70 cell therapy (autologous or allogeneic), TCR-T therapy, etc.;
  7. Prior receipt of CAR-T therapy or other cell/gene therapy;
  8. Presence of acute or moderate-to-severe chronic (GVHD) within 4 weeks prior to ICF signing, or receipt of systemic medicinal treatment for GVHD within 4 weeks prior to first infusion;
  9. Receipt of any product or systemic antitumor therapy within 28 days prior to first infusion (or five half-lives of the drug, whichever is more appropriate at the investigator's discretion);
  10. Receipt of extensive radiotherapy within 28 days prior to ICF signing, except for local radiotherapy for symptomatic relief of non-target lesions administered within 14 days prior to ICF signing or anticipated during the study period;
  11. Major surgical procedure within 28 days prior to ICF signing, or anticipated major surgical procedure during the study period;
  12. Any uncontrolled active infection requiring parenteral antibiotic, antiviral or antifungal therapy at the time of ICF signing or within 4 weeks prior to first infusion;
  13. History of active pulmonary tuberculosis within 1 year before screening (except for subjects with a history of active pulmonary tuberculosis more than 1 year earlier who are judged by the investigator to have no current evidence of active pulmonary tuberculosis);
  14. Concurrent or prior history of interstitial lung disease or interstitial pneumonia;
  15. Active or previously-occurred diseases with potential for relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk for such diseases;
  16. Requirement for systemic (≥10 mg/day prednisone equivalent) or other agents within 2 weeks prior to ICF signing or during the study period, except for: a) intranasal, inhaled, topical steroids or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiological doses ≤10 mg/day prednisone equivalent; c) steroids for prophylaxis against reactions (e.g., premedication prior to computed tomography [CT]);
  17. thyroid dysfunction as judged by the investigator;
  18. Clinically significant cardiovascular disease, including any of the following: a) heart-rate- interval (QTcF) >470 msec; b) (NYHA) class II or higher heart failure; c) (LVEF) ≤50%; d) uncontrolled hypertension (systolic blood pressure ≥150 mm Hg and/or diastolic blood pressure ≥95 mm Hg); e) arrhythmias of clinical significance or requiring antiarrhythmic therapy (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, complete left bundle-branch block, etc.); f) unstable angina or acute myocardial infarction within 6 months prior to ICF signing;
  19. Insufficient bone marrow reserve or organ function meeting any of the following laboratory criteria: a) \<1.5×10⁹/L; b) count \<50×10⁹/L; c) \<70 g/L; d) abnormal coagulation parameters: (INR) >2.0 or prothrombin time (PT) >1.5 × (ULN); e) (ALT) >2.5 × ULN; f) aspartate aminotransferase (AST) >2.5 × ULN; g) total >2.5 × ULN; h) serum \<60 mL/min (calculated by the Cockcroft-Gault formula);
  20. History of bleeding events within 6 months prior to ICF signing; clinically significant bleeding requiring medical intervention within 28 days before screening, including esophageal variceal bleeding;
  21. Vaccination with live-attenuated/inactivated vaccines within 28 days prior to ICF signing, or planned administration of live-attenuated/inactivated vaccines during the screening period;
  22. Subjects whose comorbidities or other circumstances, in the investigator's opinion, may impair protocol compliance or render the subject ineligible for study participation;
  23. Female subjects who are pregnant or breastfeeding.
Terms in these criteria, in plain language(34)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Drug: CHT101

Interventions

  • DrugCHT101

    Single-dose and multiple-dose administration Method of Administration: Intravenous infusion Dose of Administration:3.6\*10\^9 CAR-T cells,7.2\*10\^9 CAR-T cells,10\*10\^9 CAR-T cells.

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: Day 28

  2. To assess the incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs).

    Time frame: Throughout the study period, up to 24 months

Secondary outcomes

  1. Peripheral blood CAR-T cell proportion

    Time frame: Day 1,Day 2,Day 4,Day 7,Day 11,Day 14,Day 18,Day 21,Day 28,Month 2,Month 3,Month 4,Month 5,Month 6,Month 9,Month 12,Month 15,Month 18,Month 21,Month 24

  2. ORR

    Time frame: Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

  3. DOR

    Time frame: Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

  4. PFS

    Time frame: Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

  5. OS

    Time frame: Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

  6. Peripheral blood CAR copy number

    Time frame: Day 1,Day 2,Day 4,Day 7,Day 11,Day 14,Day 18,Day 21,Day 28,Month 2,Month 3,Month 4,Month 5,Month 6,Month 9,Month 12,Month 15,Month 18,Month 21,Month 24

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.

Of 64 non-industry phase 1 interventional studies under Hematologic Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 88. This study's planned 27 months is below that.

Counting every sponsor, half of 159 studies reached it within 51 months; a quarter within 28 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2026
First posted
Sep 9, 2026
StartEst.
Sep 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07809139
Lead sponsor
Nanjing Miracle Biotechnology Co., Ltd.
Collaborators
Jiangxi Provincial Cancer Hospital
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Chao Dai
Contact
chao.dai@njmiracle.com
15850641905

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: CHT101

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