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

A Phase I, Single-Arm, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of CHT101 Injection in Subjects With Relapsed/Refractory T-Cell and B-Cell Hematological Malignancies

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hematological Malignancies
• Intervention / Treatment: Drug: CHT101

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chao Dai; Phone Number: 15850641905; Email: chao.dai@njmiracle.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Cancer hospital
      • Contact: Wuping Li; Phone Number: 13870659916; Email: 18907001021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Understand and voluntarily provide written informed consent (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 relapsed/refractory T-cell malignancies with measurable disease 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 line of therapy; 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 autologous 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 PD-1 therapy), with at least one measurable lesion per the Lugano 2014 lymphoma response evaluation criteria;
7. Eastern Cooperative Oncology Group (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 child-bearing potential must agree to use effective contraception from the time of ICF signing until 2 years after administration of investigational product. Female subjects of child-bearing potential include pre-menopausal women and women within 2 years post-menopause. Serum pregnancy test must be negative for female subjects of child-bearing potential at screening.

Exclusion Criteria:

1. Central nervous system (CNS) metastasis, leptomeningeal disease 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 malignancies 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 HBV DNA in peripheral blood at screening; subjects positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; subjects positive for human immunodeficiency virus (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 graft-versus-host disease (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 investigational 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 autoimmune 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 corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressive 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 hypersensitivity reactions (e.g., premedication prior to computed tomography [CT]);
17. Clinically significant thyroid dysfunction as judged by the investigator;
18. Clinically significant cardiovascular disease, including any of the following: a) heart-rate-corrected QT interval (QTcF) >470 msec; b) New York Heart Association (NYHA) class II or higher heart failure; c) left ventricular ejection fraction (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) absolute neutrophil count <1.5×10⁹/L; b) platelet count <50×10⁹/L; c) hemoglobin <70 g/L; d) abnormal coagulation parameters: international normalized ratio (INR) >2.0 or prothrombin time (PT) >1.5 × upper limit of normal (ULN); e) alanine aminotransferase (ALT) >2.5 × ULN; f) aspartate aminotransferase (AST) >2.5 × ULN; g) total bilirubin >2.5 × ULN; h) serum creatinine clearance <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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Drug: CHT101; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose (MTD)	Day 28
To assess the incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs).	Throughout the study period, up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Peripheral blood CAR-T cell proportion	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	Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24
DOR	Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24
PFS	Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24
OS	Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24
Peripheral blood CAR copy number	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

Collaborators and Investigators

• Sponsor: Nanjing Miracle Biotechnology Co., Ltd.
• Collaborators: Jiangxi Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 28, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: UCAR-T
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: CHT101HIIT-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No