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Systemic Lupus Erythematosus (SLE)Early Phase 1NCT06946485

Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus

A Early Phase 1 study testing Universal anti-CD70 CAR-T (CHT101) in people with Systemic Lupus Erythematosus (SLE), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus (SLE)
What is being tested?
Universal anti-CD70 CAR-T (CHT101)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
2 Apr 2025to Mar 2027
Phase
Early 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
  • SLEDAI-2000 score >6.
  • Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
  • Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg/kg/day) combined with cyclophosphamide and ≥1 of the following immunosuppressants for >6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and/or biologics (e.g., rituximab, belimumab, telitacicept).
  • Aged 18-65 years; both genders eligible.
  • Adequate organ function:Bone marrow function: White blood cell count ≥3×10⁹/L. Absolute neutrophil count ≥1×10⁹/L (without colony-stimulating factor therapy within 2 weeks prior to testing). Hemoglobin ≥60 g/L; Liver function: Alanine aminotransferase (ALT) ≤3×upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤3×ULN. Total bilirubin (TBIL) ≤1.5×ULN (except Gilbert's syndrome, TBIL ≤3.0×ULN); Renal function: Creatinine clearance (CrCl) ≥60 mL/min (calculated by Cockcroft-Gault formula); Coagulation: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN; Cardiac function: Hemodynamic stability with left ventricular ejection fraction (LVEF) ≥55%.
  • Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. Females of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating.
  • Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.

Who cannot join

  • Presence of neuropsychiatric lupus (NPSLE).
  • History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
  • History of severe drug allergies or hypersensitivity.
  • Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).
  • Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.
  • Severe cardiac diseases.
Show all 14Show fewer
  • Congenital immunoglobulin deficiency.
  • History of malignancy (except non-melanoma skin cancer, in situ cervical/bladder/breast/thyroid carcinoma with disease-free survival >5 years).
  • End-stage renal failure.
  • Participants meeting any of the following: Hepatitis B surface antigen (HBsAg)-positive or hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA; Hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; HIV antibody-positive; Syphilis-positive (RPR and TPHA positive, or TPHA positive with RPR reconfirmed positive after 4 weeks).
  • Psychiatric disorders or severe cognitive impairment.
  • Participation in other clinical trials within 3 months prior to enrollment.
  • Pregnant women or those planning pregnancy.
  • Other conditions deemed by the investigator to preclude study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaojun Tang contact

18021397168

xjtang09@163.com

China1 site, 1 recruiting

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study of the Safety and Efficacy of Universal Anti-CD70 CAR-T (CHT101) for the Treatment of Relapsed and Refractory Systemic Lupus Erythematosus

This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.

Read the detailed description

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.

Being tested
Universal anti-CD70 CAR-T (CHT101)
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

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

  • Universal anti-CD70 CAR-T (CHT101)Biological

    Universal anti-CD70 CAR-T (CHT101) cell therpy

Study groups in NCT06946485
Study groupRoleWhat they receive
Universal anti-CD70 CAR-T (CHT101)ExperimentalNot described
Receives: Biological: Universal anti-CD70 CAR-T (CHT101)

What is being measured

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

  1. SRI-4 Response

    SRI-4 Response defined as a decrease of ≥4 points from baseline in the SELENA-SLEDAI score, no new BILAG-evaluated grade A organs or <2 BILAG-evaluated grade B organs from baseline, and no deterioration in the physician's overall assessment (an increase of <0.30 points from baseline).

    Measured: SRI-4 response assessed at Month 3 after CHT101 infusion.

  2. Safety Evaluation

    Safety evaluation includes the collection of adverse events (AE), serious adverse events (SAE), vital signs and physical examinations, laboratory tests, including pregnancy tests and concomitant treatments. Safety is evaluated using the NCI-CTCAE 5.0 standard. CRS is evaluated using the ASTCT Consensus Grading Criteria, ICANS is evaluated using the Adult ASTCT ICANS Consensus Grading Criteria, acute GVHD is evaluated using the 2016 Mount Sinai Acute GVHD International Consortium Grading Criteria, and chronic GVHD is evaluated using the 2020 NCCN Hematopoietic Cell Transplantation Clinical Practice Guidelines, Version 1.0.

    Measured: safety evaluation Within 12 months after CHT101 infusion.

Secondary outcomes (9)

  1. DORIS remission

    The remission of SLE was based on the DORIS 2021 criteria, namely: SLEDAI=0 and PGA < 0.5 (0-3 points), serology was not considered, and patients could use antimalarial drugs, low-dose glucocorticoids (prednisolone ≤5mg/ day), and/or immunosuppressants including biologics.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

  2. Lupus Low Disease Activity State (LLDAS) remission

    requiring simultaneous fulfillment of all the following criteria:

    • SLEDAI-2K score ≤4, with no active involvement of major organs (kidneys, central nervous system, heart/lungs, gastrointestinal tract, vasculitis, or fever);
    • PGA score ≤1;
    • No new lupus-related symptoms;
    • Maintenance dose of prednisone (or equivalent) ≤7.5 mg/day.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

  3. Overall Renal Response (ORR)

    Evaluated only in participants with lupus nephritis, encompassing those achieving either complete renal response (CRR) or partial renal response (PRR).

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion

  4. Complete Renal Response (CRR)

    Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved CRR:

    • Urinary protein excretion <0.5 g/24 h or urine protein-to-creatinine ratio (UPCR) <0.5 g/g;
    • Estimated glomerular filtration rate (eGFR) decline ≤10-15% from baseline or eGFR ≥60 mL/min/1.73 m²;
    • No use of rescue medications exceeding protocol-specified thresholds prior to assessment.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

  5. Partial Renal Response (PRR)

    Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved PRR:

    • eGFR decline ≤10-15% from baseline or eGFR ≥60 mL/min/1.73 m²;
    • Improvement in 24-hour UPCR:
    • For participants with baseline UPCR ≤3.0 g/g: UPCR <1.0 g/g;
    • For participants with baseline UPCR >3.0 g/g: >50% reduction from baseline and UPCR <3.0 g/g;
    • No use of rescue medications exceeding protocol-specified thresholds prior to assessment.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

  6. Primary Efficacy Renal Response (PERR)

    Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved PERR:

    • UPCR ≤0.7 g/g;
    • eGFR decline ≤20% from baseline or eGFR ≥60 mL/min/1.73 m²;
    • No use of rescue medications exceeding protocol-specified thresholds prior to assessment.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

  7. BILAG 2004

    The absence of new organ Class A scores or two organ Class B scores indicates improvement.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

  8. Overall assessment of physicians

    The mitigation indicator was a baseline increase of less than 0.3 on a 3-point scale.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

  9. Organ Damage

    The score was based on the SLE International Cooperation Group Injury Index (SDI). The higher the index, the worse the prognosis.

    Measured: At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

Timeline

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

  1. First posted27 Apr 2025
  2. Study start2 Apr 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06946485
Sponsor's protocol ID
CHT101AIIT-01
Status last verified
Mar 2026
First submitted
2 Apr 2025
Last updated
29 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Universal anti-CD70 CAR-T (CHT101) in people with Systemic Lupus Erythematosus (SLE), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 8 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: looking for participants now, as of the sponsor's last update on 29 Jun 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?

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?

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 Xiaojun Tang (18021397168, xjtang09@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SRI-4 Response (time frame: SRI-4 response assessed at Month 3 after CHT101 infusion.). 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?

On the ClinicalTrials.gov record for NCT06946485.

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 29 Jun 2026.

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