CompletedEarly Phase 1

A Study of CTA30X Cell Injection in Patients With Relapsed or Refractory CD19-positive B-line Hematological Malignancies

China3 participantsStarted 2020-12-29

Plain-language summary

A study of CTA30X cell injection in the treatment of relapsed or refractory CD19-positive B-line hematological malignancies

Age range3 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female aged ≥ 3 and \<70 years old;
✓. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
✓. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
✓. CR not achieved after standardized chemotherapy;
✓. CR achieved following the first induction, but CR duration is ≤ 12 months;
✓. Ineffective after first or multiple remedial treatments;
✓. 2 or more recurrences;
✓. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (morphology) and/or \>1% (Flow cytometry);

✕. Patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);
✕. Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only);
✕. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);
✕. Patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only);
✕. Extensive involvement of gastrointestinal lymphoma (for NHL patients only);
✕. Radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
✕. Have a history of allergy to any of the components in the cell products;
✕. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;

Dose-limiting toxicity (DLT)

Timeframe: Baseline up to 28 days after CTA30X infusion

Incidence of treatment-emergent adverse events (TEAEs)

Timeframe: Up to 2 years after CTA30X infusion

NCT IDNCT04689204

SponsorHe Huang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-29

Who can participate

Age range3 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female aged ≥ 3 and \<70 years old;
✓. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
✓. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
✓. CR not achieved after standardized chemotherapy;
✓. CR achieved following the first induction, but CR duration is ≤ 12 months;
✓. Ineffective after first or multiple remedial treatments;
✓. 2 or more recurrences;
✓. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (morphology) and/or \>1% (Flow cytometry);

✕. Patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);
✕. Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only);
✕. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);
✕. Patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only);
✕. Extensive involvement of gastrointestinal lymphoma (for NHL patients only);
✕. Radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
✕. Have a history of allergy to any of the components in the cell products;
✕. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;