LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma

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Brief Title

LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma

Official Title

An Open Label, Single Center, Single Arm Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma

Brief Summary

      An open label, single center, single arm Phase I study to evaluate the safety, tolerability,
      and pharmacokinetics of LCAR-T2C CAR-T cells in relapsed or refractory CD4+ T-cell lymphoma.

Detailed Description

      This study is an open, dose escalation/dose regimen finding study to assess the safety and
      pharmacokinetics of CD4-directed CAR-T cells administered with lymphodepletion, and to obtain
      the preliminary efficacy results in subjects who have been diagnosed with relapsed or
      refractory CD4 positive peripheral T-cell lymphoma, not otherwise specified,
      angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma. The auto-CAR-T cells
      will be infused in single-dose.

Study Phase

Phase 1

Study Type


Primary Outcome

Dose limiting toxicity (DLT)

Secondary Outcome

 Overall response rate (ORR) after administration


CD4+ T-cell Lymphoma


Efficacy of LCAR-T2C CAR-T cells

Study Arms / Comparison Groups

 LCAR-T2C CAR-T cells in relapsed or refractory CD4+ T-cell lym
Description:  An open label, single center, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LCAR-T2C CAR-T cells in relapsed or refractory CD4+ T-cell lymphoma.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 30, 2019

Completion Date

February 28, 2023

Primary Completion Date

November 29, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent form (ICF)

          2. Age 18 Years to 75 Years

          3. Pathological diagnosis of refractory/relapsed CD4+ T-cell lymphoma (one of the

               1. Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL, NOS)

               2. Angioimmunoblastic T-Cell Lymphoma (AITL)

               3. Anaplastic Large Cell Lymphoma (ALCL)

          4. Measurable disease as defined by 2014 Lugano criteria at Screening

          5. Refractory/relapsed disease after at least 1 prior line of therapy (Undergone at least
             2 complete cycle of therapy for each line, unless PD been documented as the best
             response to the regimen) and not eligible or appropriate for HSCT (Auto/ Allo).
             Subjects must have documented disease progression (PD) during the most recent
             treatment or within 12 months after treatment. In addition, subjects who are
             refractory or non-responsive to their most recent line of treatment are eligible.
             (Non-responsive disease is defined as either failure to achieve partial response (PR)
             and abrove or development of progressive disease (PD) while on therapy).

          6. Life expectancy ≥ 12 weeks

          7. Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 -2.

          8. The screening phase clinical laboratory values meet the following criteria. Laboratory
             test(s) may be repeated once, to determine if the subject qualifies for study
             participation :

               -  Blood routine: HGB≥8g/dL;PLT≥50×10^9/L; ANC≥1.0×10^9/L; LY≥0.3×10^9/L ② Blood
                  biochemical parameters:

                    1. Aspartate and alanine aminotransferases (AST, ALT) ≤ 2.5 times ULN (in the
                       presence of liver metastasis, AST and ALT≤5 times ULN)

                    2. Serum creatinine (Scr) ≤ 1.5 times ULN, estimated glomerular filtration rate
                       (eGFR) > 60mL/min (only when Scr>1.5 times ULN)

                    3. Total bilirubin ≤ 1.5 times of the normal upper limit (ULN)

                    4. Total cholesterol <300 mg / dL or <7.75 mmol / L

                    5. Triglyceride < 2.5 times ULN

                    6. International Normalized Ratio (INR) ≤ 1.5 times ULN, PT≤ 1.5 times ULN,
                       APTT≤ 1.5 times ULN

        Exclusion Criteria:

          1. Prior treatment with CAR-T therapy directed at any target.

          2. Any therapy that is targeted to CD4.

          3. Prior treatment with an allogeneic stem cell transplant

          4. Any malignancy besides the T-cell lymphoma categories under study, exceptions include

               1. Any other malignancy curatively treated and disease-free for at least 2 years
                  prior to enrollment

               2. History of non-melanoma skin cancer with sufficient treatment and currently no
                  evidence of recurrence

          5. Those who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis
             B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C
             virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab)

          6. The following cardiac conditions:

               1. New York Heart Association (NYHA) stage III or IV congestive heart failure

               2. Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to

               3. History of clinically significant ventricular arrhythmia or unexplained syncope,
                  not believed to be vasovagal in nature or due to dehydration

               4. History of severe non-ischemic cardiomyopathy

               5. Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or
                  multiple-gated acquisition (MUGA) scan (performed ≤8 weeks of apheresis)

          7. Prior antitumor therapy as follows, prior to apheresis:

               1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug
                  or used an invasive investigational medical device within 14 days or at least 5
                  half-lives, whichever is less.

               2. Monoclonal antibody treatment for multiple myeloma within 21 days.

               3. Cytotoxic therapy within 14 days.

               4. Radiotherapy within 14 days.

          8. Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade
             1 or less except for alopecia or peripheral neuropathy.

          9. With central nervous system involvement.

         10. Participated in other clinical trials within 30 days.

         11. Serious underlying medical condition, such as:

               1. Evidence of serious active viral, bacterial, or uncontrolled systemic fungal

               2. Active autoimmune disease or a history of autoimmune disease within 3 years

               3. Overt clinical evidence of dementia or altered mental status

         12. Pregnant or breast-feeding, or planning to become pregnant while enrolled in this
             study or within 100 days after receiving study treatment.

         13. Plans to father a child while enrolled in this study or within 100 days after
             receiving study treatment.

         14. With obvious hemorrhagic tendency such as gastrointestinal hemorrhage, coagulation
             disorders and hypersplenism

         15. Pulse oximetry of <96% on room air

         16. Received a cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone
             within 7 days prior to apheresis

         17. Concurrent use of hematopoietic growth factor

         18. Concurrent anti-cancer therapy including radiotherapy

         19. Stroke or seizure within 6 months of signing ICF

         20. Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis

         21. Major surgery within 2 weeks prior to apheresis, or has surgery planned during the
             study or within 2 weeks after study treatment administration. (Note: subjects with
             planned surgical procedures to be conducted under local anesthesia may participate.)

         22. Known life threatening allergies, hypersensitivity, or intolerance to LCAR-T2C CAR-T
             cells or its excipients, including DMSO (refer to Investigator's Brochure)




18 Years - 75 Years

Accepts Healthy Volunteers



Wei Xu, PhD& MD, +8668306034, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

The First Affiliated Hospital with Nanjing Medical University


 Nanjing Legend Biotechnology Co.,Ltd.

Study Sponsor

Wei Xu, PhD& MD, Principal Investigator, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Verification Date

January 2021