Hematological MalignanciesPhase 1NCT07809126
A Phase I, Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of CHT101 Injection in Subjects With Relapsed/Refractory T-Cell and B-Cell Hematological Malignancies
A Phase 1 study testing CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) in people with Hematological Malignancies, run by Nanjing Miracle Biotechnology Co., Ltd. at 1 site in China.
Trial summary
Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of subjects with CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior to performing any study-related assessments/procedures, understand and voluntarily sign the Informed Consent Form (ICF)；
- Age between 18 and 70 years (inclusive) at the time of signing the ICF;
- Tumor cells in bone marrow or peripheral blood are CD70-positive as detected by flow cytometry; or CD70-positive by immunohistochemistry (IHC) testing of tumor tissue;
- Relapsed/refractory T-cell malignancies with measurable disease defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion detected by imaging (PET-CT or CT) per Lugano criteria (lymph node lesion: any diameter >1.5 cm; extranodal lesion: 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, disease involving two or more regions, or single-region disease with large-cell transformation]), and have received prior systemic therapy: patients with peripheral T-cell lymphoma must have received at least 1 line of therapy; patients with cutaneous T-cell lymphoma must have received at least 2 lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin-containing therapy, or relapsed after ≥2 prior lines of therapy (if anaplastic lymphoma kinase-positive)；
- 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 lines of therapy, with prior treatment regimens containing anti-CD20 antibody; Chronic lymphocytic leukemia (CLL): relapsed or refractory after at least two lines of therapy, with prior treatment regimens containing both 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 lines of therapy, with prior treatment regimens containing anti-CD20 antibody and anthracycline, and the subject is ineligible for autologous stem cell transplantation (conditions for ineligibility for autologous stem cell transplantation include lack 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 lines of prior therapy；
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- Histopathologically confirmed classical Hodgkin lymphoma (cHL), which is relapsed or refractory (after brentuximab vedotin and PD-1 inhibitor therapy), with at least one measurable lesion consistent with Lugano 2014 lymphoma response evaluation criteria；
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at the time of signing the ICF;
- Expected survival of no less than 12 weeks;
- Fertile males and females of child-bearing potential must agree to use effective contraceptive measures from the time of signing the Informed Consent Form (ICF) until 2 years after administration of the study drug. Females of child-bearing potential include pre-menopausal women and women within 2 years post-menopause. A serum pregnancy test must be negative for females of child-bearing potential at screening.
Who cannot join
- Central nervous system (CNS) metastasis, leptomeningeal disease or metastatic spinal cord compression; or prior history of CNS diseases, including but not limited to seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc；
- History of organ transplantation;
- History of other primary malignancies within 5 years prior to study treatment, with the following exceptions:
- Cervical carcinoma in situ that has been adequately treated and cured;
- Localized basal-cell carcinoma or squamous-cell carcinoma of the skin;
- Subjects with positive hepatitis B surface antigen (HBsAg) at screening should be excluded; for subjects with negative HBsAg but positive hepatitis B core antibody (HBcAb), those with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection should be excluded; subjects with positive hepatitis C virus (HCV) antibody and positive HCV RNA should be excluded; subjects with positive human immunodeficiency virus (HIV) antibody; subjects with both positive treponema-specific antibody and non-specific syphilis antibody tests；
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- Subjects with hypersensitivity to any components of the investigational products used in this study, including but not limited to lymphodepleting agents (cyclophosphamide, fludarabine), and contrast media for imaging examinations；
- Prior receipt of anti-CD70-targeted anti-tumor therapy, including but not limited to CD70-targeted cell therapy (autologous or allogeneic), TCR-T therapy, etc；
- Prior receipt of CAR-T therapy or other cell/gene therapy;
- Presence of acute or moderate-to-severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to ICF signing, or receipt of systemic pharmacological therapy for GVHD within 4 weeks prior to the first infusion；
- Receipt of any investigational drug or systemic anti-tumor therapy within 28 days (or 5 half-lives of the drug, whichever is deemed more appropriate by the Investigator) prior to the first infusion;
- Receipt of extensive-field radiotherapy within 28 days prior to the time of signing the ICF, except for local radiotherapy for symptom relief to non-target lesions administered within 14 days prior to ICF signing or anticipated to be administered during the study period；
- Receipt of major surgical procedure within 28 days prior to the time of signing the ICF, or anticipated major surgical procedure during the study period；
- Uncontrolled active infection requiring parenteral antibiotic, antiviral or antifungal therapy at the time of signing the ICF or within 4 weeks prior to the first infusion;
- History of active pulmonary tuberculosis infection within 1 year prior to screening (subjects with history of active pulmonary tuberculosis infection more than 1 year ago are excluded unless the Investigator judges that there is no current evidence of active pulmonary tuberculosis)；
- Concurrent or prior history of interstitial lung disease or interstitial pneumonitis;
- Subject has active or previously-treated autoimmune disease with potential for recurrence (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis), or is at risk for such disease；
- Requirement for systemic corticosteroids at a dose equivalent to or greater than 10 mg/day prednisone, or other immunosuppressive therapy within 2 weeks prior to the time of signing the ICF or during the study period, except for the following:
- Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection);
- Systemic corticosteroid therapy at prednisone-equivalent physiological dose no more than 10 mg/day;
- Steroids used for prophylaxis against allergic reactions (e.g., pre-medication prior to computed tomography [CT] scanning).
- Clinically significant thyroid dysfunction as judged by the Investigator；
- Clinically significant cardiovascular disease, including any of the following:
- Fridericia-corrected QT interval (QTcF) > 470 msec;
- New York Heart Association (NYHA) class II or higher heart failure;
- Left ventricular ejection fraction (LVEF) ≤ 50%;
- Uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 95 mm Hg);
- Clinically significant arrhythmias requiring anti-arrhythmic therapy, including but not limited to sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, complete left bundle-branch block;
- Unstable angina or acute myocardial infarction within 6 months prior to the time of signing the ICF.
- Insufficient bone marrow reserve or impaired organ function, defined by any of the following laboratory findings:
- Absolute neutrophil count (ANC) < 1.5 × 10⁹/L;
- Platelet count < 50 × 10⁹/L;
- Hemoglobin < 70 g/L;
- Abnormal coagulation tests: international normalized ratio (INR) > 2.0 or prothrombin time (PT) > 1.5 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) > 1.5 × ULN;
- Aspartate aminotransferase (AST) > 1.5 × ULN;
- Total bilirubin > 1.5 × ULN;
- Serum creatinine clearance < 60 mL/min (calculated by the Cockcroft-Gault formula).
- History of bleeding events within 6 months prior to the time of signing the ICF; clinically significant bleeding requiring medical intervention within 28 days prior to screening, including esophageal variceal bleeding;
- Receipt of live-attenuated or inactivated vaccines within 28 days prior to the time of signing the ICF, or planned administration of live-attenuated or inactivated vaccines during the screening period;
- Subject has comorbidities or other conditions that, in the Investigator's opinion, may impair protocol compliance or render the subject unsuitable for participation in this study;
- Female subjects who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Fei Li, 13970038386, yx021021@sina.com
About this study
Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of subjects with CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies.
Primary Endpoint: MTD, RP2D or biologically effective dose; to assess the incidence, severity and relatedness of AEs and SAEs.
Indication: CD70-positive relapsed or refractory T-cell and B-cell hematological malignancies
- Conditions
- Hematological Malignancies
- Being tested
- CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101)Drug
single or multiple administrations，3.6*10^9 CAR-T cells，7.2*10^9 CAR-T cells，10*10^9 CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Measured: Day 28
To assess the incidence,severity and relatedness of AEs and SAEs.
Measured: through study completion,up to 24 months
Secondary outcomes (6)
Peripheral blood CAR-T cell proportion
Measured: 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
ORR
Measured: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
DOR
Measured: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
PFS
Measured: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
OS
Measured: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
Peripheral blood CAR copy number
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Miracle Biotechnology Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809126
- Sponsor's protocol ID
- CHT101HIIT-03
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of CHT101 Injection in Subjects With Relapsed/Refractory T-Cell and B-Cell Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07809126
- Acronym / sponsor ID
- CHT101HIIT-03
- Conditions
- Hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing Miracle Biotechnology Co., Ltd.University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Sep 2026 (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.
Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of subjects with CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies.
Primary Endpoint: MTD, RP2D or biologically effective dose; to assess the incidence, severity and relatedness of AEs and SAEs.
Indication: CD70-positive relapsed or refractory T-cell and B-cell hematological malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Prior to performing any study-related assessments/procedures, understand and voluntarily sign the Informed Consent Form (ICF)；
- Age between 18 and 70 years (inclusive) at the time of signing the ICF;
- Tumor cells in bone marrow or peripheral blood are CD70-positive as detected by flow cytometry; or CD70-positive by immunohistochemistry (IHC) testing of tumor tissue;
- Relapsed/refractory T-cell malignancies with measurable disease defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion detected by imaging (PET-CT or CT) per Lugano criteria (lymph node lesion: any diameter >1.5 cm; extranodal lesion: 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, disease involving two or more regions, or single-region disease with large-cell transformation]), and have received prior systemic therapy: patients with peripheral T-cell lymphoma must have received at least 1 line of therapy; patients with cutaneous T-cell lymphoma must have received at least 2 lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin-containing therapy, or relapsed after ≥2 prior lines of therapy (if anaplastic lymphoma kinase-positive)；
- Relapsed/refractory B-cell malignancies with at least one measurable lesion and meeting at least one of the following criteria:
Key exclusion criteria (42 listed)
- Central nervous system (CNS) metastasis, leptomeningeal disease or metastatic spinal cord compression; or prior history of CNS diseases, including but not limited to seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc；
- History of organ transplantation;
- History of other primary malignancies within 5 years prior to study treatment, with the following exceptions:
- Subjects with positive hepatitis B surface antigen (HBsAg) at screening should be excluded; for subjects with negative HBsAg but positive hepatitis B core antibody (HBcAb), those with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection should be excluded; subjects with positive hepatitis C virus (HCV) antibody and positive HCV RNA should be excluded; subjects with positive human immunodeficiency virus (HIV) antibody; subjects with both positive treponema-specific antibody and non-specific syphilis antibody tests；
- Subjects with hypersensitivity to any components of the investigational products used in this study, including but not limited to lymphodepleting agents (cyclophosphamide, fludarabine), and contrast media for imaging examinations；
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 |
|---|---|---|
| CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101)single or multiple administrations，3.6*10^9 CAR-T cells，7.2*10^9 CAR-T cells，10*10^9 CAR-T cells. | Drug | treatment group |
Primary outcome
MTD
Time frame: Day 28
To assess the incidence,severity and relatedness of AEs and SAEs.
Time frame: through study completion,up to 24 months
6 secondary outcomes
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
ORR
Time frame: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
DOR
Time frame: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
PFS
Time frame: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
OS
Time frame: Week 4,Month 2,Month 3,Month 6,Month 9,Month 12,Month 15,Month 18,Month 24
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) in people with Hematological Malignancies, run by Nanjing Miracle Biotechnology Co., Ltd. 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 10 inclusion and 42 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: opening soon, as of the sponsor's last update on 9 Sep 2026. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Dai (15850641905, chao.dai@njmiracle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.