## Protocol Section
### Identification Module
**NCT ID:** NCT04012879

**Brief Title:** Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia

**Official Title:** Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia

#### Organization Study ID Info
**ID:** HEM-ALL001-CART
#### Organization
**Class:** OTHER
**Full Name:** Chinese PLA General Hospital
### Status Module
#### Completion Date
**Date:** 2021-06-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-07-09

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-07

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-05-01

**Type:** ACTUAL

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2019-07-09
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-28
**Study First Submit QC Date:** 2019-07-07
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Shenzhen University General Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Chinese PLA General Hospital

#### Responsible Party

**Investigator Affiliation:** Chinese PLA General Hospital

**Investigator Full Name:** Li Yu

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory acute lymphoblasic leukemia.

### Conditions Module

**Conditions:**

- Relapsed Acute Lymphoblastic Leukemia

- Refractory Acute Lymphoblastic Leukemia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 12

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10\^4 cells/kg in 36-96 hours

**Intervention Names:**

- Combination Product: CD19 CART

**Label:** study group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- study group

**Description:** CD19 CART

**Name:** CD19 CART

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T

**Measure:** recovery rate of patients being treated with CD19CAR-T

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive
2. Age 18 to 65 years old, both male and female;
3. Is expected to survive more than 12 weeks;
4. Physical condition is good: 0-1 score ECOG score;
5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
3. Pregnancy and lactation women;
4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
5. The Investigator believe the patients should not participate in this experiment.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wanglixin1991@sohu.com

**Name:** Lixing Wang, M.D.

**Phone:** 86-0755-21839178

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shenzhen

**Contacts:**

***Contact 1:***

- **Email:** wanglixin1991@sohu.com

- **Name:** Lixing Wang, M.D.

- **Phone:** 86-0755-21839178

- **Role:** CONTACT

***Contact 2:***

- **Name:** Li Yu, M.D. Ph.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Lixing Wang, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shenzhen University General Hospital

**Status:** RECRUITING

**Zip:** 518000

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: HIGH

- As Found: Lymphoblastic Leukemia

- ID: M27585

- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T175

- Name: Acute Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T3533

- Name: Lymphoblastic Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000054198

- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- ID: D000007945

- Term: Leukemia, Lymphoid

### Misc Info Module

- Version Holder: 2024-05-24
