CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL

NCT06445803 | Recruiting Phase 1 DMC

• 1 other identifier: KQ-2002-XC001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.

Conditions

Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia With Failed Remission; B-cell Lymphoma Refractory; B-cell Lymphoma Recurrent

Keywords

CAR-T therapy

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-limiting toxicity

  Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  Up to 28 days

• Incidence and severity of adverse events

  Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  Up to 15 years

Secondary Outcomes (5)

• Overall response rate

  up to 15 years

• Progression free survival

  up to 15 years

• Overall survival

  up to 15 years

• MRD negative response rates（ Acute Lymphoblastic Leukemia ）

  up to 15 years

• Persistence of CD19/CD22 CAR-T cells blood, bone marrow

  up to 15 years

Study Arms (2)

Dose escalation

EXPERIMENTAL

CD19/CD22-CAR-transduced T cells at escalating doses (0.5\~5.0 ×10\^6 cells/kg)

Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）

Dose expansion

EXPERIMENTAL

CD19/CD22-CAR-transduced T cells at MTD or highest dose administered

Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）

Interventions

KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells） BIOLOGICAL

CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen. Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide. Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3)

Dose escalation; Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female,≥18 years old;
• Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):
• (B-NHL)
• Second or greater relapse (CD20 regimens must be included) OR
• Refractory to first-line chemotherapy or relapse within 1 year OR
• Relapse within 1 year of auto-HSCT.
• With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)
• a. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.
• ECOG 0\~2
• Estimated survival time ≥ 12 weeks;
• Main tissues and organs function well.

You may not qualify if:

• Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h
• Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
• Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；
• active bleeding, or venous thromboembolic event
• Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs
• Central nervous system (CNS) disease or symptoms of CNS involvement
• Pregnant or nursing (lactating) women
• Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded
• Any Iinappropriate conditions in the opinion of the PI .

Sponsors & Collaborators

• Rong Tao: lead
• Novatim Immune Therapeutics (Zhejiang) Co., Ltd.: collaborator

Study Sites (2)

The First Affiliated Hospital of Nanchang University;

Nanchang, Jiangxi, 360000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rong Tao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijing Zhang

CONTACT

021-64175590; JJYIN555@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)