Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies

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Brief Title

Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies

Official Title

Anti-CD7 Universal CAR-T Cells for CD7+ T/NK Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial

Brief Summary

      The prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is
      poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19
      CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell
      hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target
      expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical
      experiments is cheerful.however, how to select the functional T cells from the malignant T
      cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the
      majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of
      the host as the material of anti-CD7 universal CAR-T cells could be accessible and
      affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell
      hematologic malignancies.

Study Phase

Early Phase 1

Study Type


Primary Outcome

the anti-tumor efficiency of anti-CD7 UCAR-T cells

Secondary Outcome

 the long-term efficiency of anti-CD7 UCAR-T cells


T-cell Leukemia


CD7 UCAR-T cells

Study Arms / Comparison Groups

 anti-CD7 UCAR-T cells
Description:  After preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD7 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated


* 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

March 1, 2021

Completion Date

June 1, 2023

Primary Completion Date

June 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute
             lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including
             Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma
             (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral
             T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell
             leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal
             NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher))

             2. CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or
             immunohistochemistry (tissue))

             3. Hgb ≥ 7.0 (can be transfused)

             4. Life expectancy greater than 12 weeks

             5. Informed consent explained to, understood by and signed by the patient/guardian.
             Patient/guardian is given a copy of informed consent.

        Exclusion Criteria:

          1. Pregnant or lactating.

          2. Tumor in a location where enlargement could cause airway obstruction (per investigator

          3. Active infection with HIV or HTLV.

          4. Clinically significant viral infection or uncontrolled viral reactivation of
             EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human

          5. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial
             infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT,
             per investigator discretion. Cardiac echocardiography with LVSF (left ventricular
             shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or
             clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart
             Association) III or IV (Confirmation of absence of these conditions on echocardiogram
             within 12 months of treatment).

          6. CNS abnormalities: Presence of CNS(central nervous system)-3 disease defined as
             detectable cerebrospinal blast cells in a sample of CSF(cerebrospinal fluid) with ≥ 5
             WBC( white blood cell)s per mm3 (unless negative by the Steinherz/Bleyer algorithm);
             Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular
             ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS




18 Years - 70 Years

Accepts Healthy Volunteers



Xi Zhang, MD, +8613808310064, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Xinqiao Hospital of Chongqing


 Gracell Biotechnology Shanghai Co., Ltd.

Study Sponsor

Xi Zhang, MD, Principal Investigator, Xinqiao Hospital of Chongqing

Verification Date

June 2021