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Status unknownNCT04516551Updated Nov 17, 2020

Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT

A Phase 1 interventional study of anti-CD19 allo-CAR-T cells in Relapsed Adult ALL and B Cell Leukemia, sponsored by Xinqiao Hospital of Chongqing. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by Xinqiao Hospital of Chongqing · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
14 Years to 75 Years
Sex
All
01

Study summary

The patients with relapsed B cell acute lymphoblastic leukemia (ALL) after hematopoietic stem cell transplant (HSCT) have a poor prognosis, especially for these relapsed in a short time after transplantation. Nowadays there is no effective way to salvage patients in such conditions. T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability, which makes it serve well for patients with relapsed B-ALL. So we launched a multi-center clinical trial to proved the safety and efficacy of anti-CD19 CAR-T cells for relapsed B cell ALL.

Read the detailed description

The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, for B-ALL patients suffered from relapse after allo-HSCT (hematopoietic stem cell transplant), the T cells derived from healthy donor seems like a better origin for CAR-T cells producing because T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability. So after we designed a clinical trial to manifest the safety and efficacy of anti-CD19 CAR-T cells for patients with relapsed B cell ALL.

02

Conditions studied

  • Relapsed Adult ALL
  • B Cell Leukemia
03

In context

Leukemia, B-Cell

126 studies on the registry are indexed under Leukemia, B-Cell; 46 are open to participants now.

This study's planned enrollment of 18 is below the median of 40 across 110 interventional studies indexed under Leukemia, B-Cell.

Browse Leukemia, B-Cell studies →

Lead sponsor

Xinqiao Hospital of Chongqing is the lead sponsor of 68 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of relapsed B-cell acute lymphoblastic leukemia (B-ALL).
  2. Patients have received hematologic stem cell transplantation from matching sibling donor or unrelated donor.
  3. CD19-positive tumor (>20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue))
  4. Hgb ≥ 7.0 (can be transfused)
  5. Life expectancy greater than 12 weeks
  6. Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years);
  2. Severe mental disorders;
  3. A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome;
  4. Subjects with II-IV grade acute graft versus host disease GVHD (Glucksberg Standrad) or chronic GVHD.
  5. Heart disease with grade III-IV heart failure [NYHA classification], myocardial infarction, angioplasty or stenting, unstable angina or other heart diseases with prominent clinical symptoms within one year before admission;
  6. Subjects with any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, bile drainage tube or pleura/peritoneum/pericardium catheter), should be excluded. (Special central venous catheter is allowed);
  7. Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis;
  8. Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
  9. Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg;
  10. Active infection requiring systematic treatment within 2 weeks before single collection;
  11. Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy;
  12. History of autoimmune diseases (e.g. Crohn disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end-organ damage or require systemic immunosuppressive medications or systemic disease modifying drugs in the past 2 years;
  13. Presence of pulmonary fibrosis;
  14. Subjects who have received other clinical trial treatment within 4 weeks before participating in this trial should be excluded. Or the signing date of informed consent is within 5 half-lives of the last application of another clinical trial (whichever is longer);
  15. Subjects with poor compliance due to physiological, family, social, geographical and other factors, or those unable to cooperate with the study plan or follow-up;
  16. At the discretion of the investigator, there are complications requiring systemic corticosteroid therapy (≥ 5mg / day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs within 6 months after this clinical research treatment;
  17. The lactating woman who is reluctant to stop breastfeeding;
  18. Any other condition considered unsuitable by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    anti-CD19 allo-CAR-T

    The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determining optimal dosage. dosage: the number of anti CD19+CD22 CAR T cells -1(if needed) 1×10\^6/KG 3×10\^6 /KG 6×10\^6 /KG 1×10\^7/KG Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) for 3 days or bendamustione (90mg/m2 per day) for two days prior to cell infusion.

    Biological: anti-CD19 allo-CAR-T cells

Interventions

  • Biologicalanti-CD19 allo-CAR-T cells

    The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.

06

What researchers measure

Primary outcomes

  1. the safety of anti-CD19 allo CAR-T cells

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: within 4 weeks after infusion

  2. the efficacy of anti-CD19 allo CAR-T cells

    ratio of bone marrow blast cells

    Time frame: 4 weeks after infusion

Secondary outcomes

  1. The long-term efficiency

    ratio of bone marrow blast cells

    Time frame: up to 2 years after infusion

07

Study locations

1 of 1 sites recruiting
  • Department of Hematology, Xinqiao Hospital
    Chongqing, Chongqing 400037, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04516551
Lead sponsor
Xinqiao Hospital of Chongqing
Collaborators
Gracell Biotechnologies (Shanghai) Co., Ltd., First Affiliated Hospital of Zhejiang University, The Second Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Guizhou Medical University, The General Hospital of Western Theater Command, Chongqing University Cancer Hospital, The First Affiliated Hospital of Anhui Medical University, Tang-Du Hospital, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Responsible party
Xi Zhang, MD (Chef of Hematology Department, Xinqiao Hospital of Chongqing) — Principal investigator
First posted
Aug 18, 2020
Start date
Nov 20, 2020 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Nov 17, 2020

Study contacts

Xi Zhang, MD phD
Contact
zhangxxi@sina.com
13808310064 ext. +86
Ruihao Huang
Contact
1169731117@qq.com
18984398751 ext. +86
Xi Zhang, MD phD
study chair · Xinqiao Hospital of Chongqing
He Huang, MD
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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