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Outcome Measures

Primary Outcomes (2)

Dose-Limiting Toxicity (DLT)
CRS and ICANS will be assessed per ASTCT (2019), while other AEs follow CTCAE v5.0. DLTs are CAR-T-related AEs (possibly, likely, or definitely related) that occur within 28 days post-infusion and meet the following criteria: Grade 4+ CRS, or Grade 3 CRS unresolved to ≤ Grade 2 within 7 days. Grade 3+ non-hematologic toxicity unresolved to ≤ Grade 2 within 7 days. Grade 4+ ICANS, or Grade 3 ICANS unresolved to ≤ Grade 2 within 3 days. Grade 4+ hematologic toxicity (excluding lymphopenia) lasting \>28 days. Grade 3+ hypersensitivity reaction. Any unexpected toxicity requiring study discontinuation. Exemptions: Rapid hypersensitivity resolving to ≤ Grade 2 in 2 hours. Reversible Grade 3 AEs lasting ≤7 days. Transient CRS-related organ dysfunction, resolving in ≤7 days per SRC. All DLTs are reviewed by the Safety Review Committee.
Day28 after CAR-T cell infusion
Overall Response Rate (ORR)
Time Frame: Within 3 months after CAR-T cell infusion Definition: ORR is defined as the proportion of patients achieving complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS), as per European LeukemiaNet (ELN) 2022 criteria. Response Criteria (ELN 2022): Complete Remission (CR): \<5% bone marrow blasts Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L Platelet count ≥100 × 10⁹/L No evidence of extramedullary disease Full hematologic recovery Complete Remission with Incomplete Hematologic Recovery (CRi): \<5% bone marrow blasts ANC \<1.0 × 10⁹/L and/or platelet count \<100 × 10⁹/L No evidence of extramedullary disease Morphologic Leukemia-Free State (MLFS): \<5% bone marrow blasts No hematologic recovery required (ANC and platelet counts may remain low) No extramedullary leukemia
Within 3 months after CAR-T cell infusion

Secondary Outcomes (2)

Disease-Free Survival (DFS)
2-year
Overall Survival (OS)
2-year

Interventions

Nanobody-Based CD19/CD22 Tandem Dual CAR-TBiological

Phase I: Patients will receive a single infusion of autologous CD19/CD22 dual CAR-T cells at one of three dose levels (0.3 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine (25-30mg/m2\*3d) and cyclophosphamide (250-300mg/m2\*3d) (FC) lymphodepleting chemotherapy. Phase II: Patients will receive autologous CD19/CD22 dual CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.

CD19/CD22 Tandem Dual CAR-T

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Eligibility Criteria

Age12 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

The subject or their legally authorized representative (guardian) understands the study and voluntarily signs the informed consent form (ICF).
Male or female, aged 12 to 65 years at the time of signing the ICF (inclusive of the cutoff values).

MeSH Terms

Conditions

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type

interventional

Phase

phase 1 2

Allocation

Masking

NONE

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

Model Details: Phase I, a traditional 3+3 dose-escalation design and determine the recommended Phase II dose; Phase II, a single-arm, open-label study design.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Director of Peking University Institute of Hematology

Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

CD19/CD22 Tandem Dual CAR-T

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

CD19/CD22 Tandem Dual CAR-T

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations