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Blasts 5 Percent or More of Bone Marrow Nucleated CellsPhase 1/2NCT03698552

ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

A Phase 1/2 study testing ADCT-602 in people with Blasts 5 Percent or More of Bone Marrow Nucleated Cells and CD22 Positive, run by M.D. Anderson Cancer Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients with B-cell lymphoblastic leukemia that has come back or does not respond to treatment. Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ADCT-602
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
24 Aug 2018to 6 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with relapsed or refractory B-ALL. Philadelphia chromosome positive (Ph+) ALL is allowed after failing either first or second generation tyrosine kinase inhibitor. Note: Patients in first relapse with complete remission (CR1) duration > 12 months are excluded
  • Expression of CD22 in >= 20% blasts (assessed by flow-cytometry or immunohistochemistry)
  • Marrow blast count >= 5%
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Serum creatinine =< 1.5 mg/dL. If the patient has a creatinine > 1.5 mg/dL, creatinine clearance must be > 60 mL/min/1.73 m^2, as calculated by the Cockcroft and Gault equation, or modification of diet in renal disease (MDRD) formula or 24-hour urine analysis
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 times the upper limit of normal (ULN); =< 5 times ULN if there is liver or bone involvement
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  • Total bilirubin =< 1.5 times ULN. Patients with known Gilbert's syndrome may have a total bilirubin up to =< 3 times ULN.
  • NOTE: In patients (pts) with elevated total bilirubin due to increased indirect bilirubin, patients with direct bilirubin =< 1.5 x ULN are eligible
  • Left ventricular ejection fraction (LVEF) >= 45%
  • Negative urine or serum beta-human chorionic gonadotropin (B-HCG) pregnancy test within 7 days prior to the cycle 1, day 1 visit, for women of child-bearing potential. Women of child bearing potential must agree to use an effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of ADCT-602. Men with female partners who are of child bearing potential must agree that they or their partners will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of ADCT-602
  • Women of child bearing potential defined as: Sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal (i.e., who have not menstruated at all) for at least 1 year
  • Effective method of contraception defined as: Hormonal contraceptives (oral, injectable, patch, intrauterine devices), male partner sterilization, or total abstinence from heterosexual intercourse, when this is the preferred and usual lifestyle of the patient
  • NOTE: The double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide-only are not acceptable as highly effective methods of contraception
  • White blood cell (WBC) value of < 15,000 cells/uL prior to cycle 1 day 1

Who cannot join

  • Known active central nervous system (CNS) leukemia, defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), or symptomatic CNS leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days prior to screening.
  • NOTE: Patients may have a history of CNS leukemic involvement if they have received prior treatment for CNS involvement and no evidence of active disease (defined as >= 2 consecutive spinal fluid assessments with no evidence of disease) is present at screening. Prophylactic intrathecal chemotherapy is allowed on the trial and is not a criterion for exclusion
  • Patients with Burkitt's leukemia/lymphoma
  • Active graft-versus-host disease (GVHD) or severe/extensive chronic GVHD
  • Autologous or allogenic transplant within the 60 days prior to the cycle 1 day1
  • Known history of immunogenicity or hypersensitivity to a CD22 antibody
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  • Known history of positive serum human adenosine deaminase (ADA)
  • Known seropositive for human immunodeficiency (HIV), hepatitis B, or hepatitis C virus with confirmatory testing
  • History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome
  • Pregnant or breastfeeding women
  • Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure > 115 mm Hg), uncontrolled atrial or ventricular cardiac arrhythmias, unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, myocardial infarction within 6 months prior to screening
  • Use of any other experimental medication(s) within 14 days or 5 half-lives, but in no case < 14 days prior to the start of study treatment on cycle 1, day 1
  • Major surgery, chemotherapy, systemic therapy (excluding hydroxyurea, steroids and any targeted small molecules or biologics), or radiotherapy within 14 days or 5 half-lives (whichever is shorter) prior to cycle 1, day 1 treatment
  • NOTE: a) To reduce the circulating lymphoblast count or palliation: steroids and hydroxyurea are allowed. No washout necessary for these agents. b) Cytarabine IV could be used for cytoreduction with a washout of 1 week. c) For ALL maintenance/treatment: mercaptopurine, oral methotrexate, vincristine, and/or tyrosine kinase inhibitors. These agents should be discontinued at least 48 hours prior to start of study drugs. d) Patients may have received prior CD22-directed therapy provided the blasts remain CD22+ (>= 20%) and > 3 months from prior anti-CD22 exposure
  • Isolated extramedullary relapse (i.e., testicular, CNS)
  • Uncontrolled active infection
  • History of another primary invasive malignancy that has not been definitively treated or in remission for less than 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)
  • Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk
  • Inability of the patient to consent themselves for this study
  • Prior history or current veno-occlusive disease (VOD)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • City of Hope Comprehensive Cancer

    Monrovia, California, 91016

Other trials in United States

About this study

Official title: A Phase I/II Study to Evaluate the Safety and Anti-Tumor Activity of ADCT-602 Targeting CD22 in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients with B-cell lymphoblastic leukemia that has come back or does not respond to treatment. Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the safety and determine the maximum tolerated dose (MTD) of ADCT-602 in patients with relapsed or refractory B-cell (B)-acute lymphoblastic leukemia (ALL) in Phase 1.

II. Determine the recommended dose of ADCT-602 for Phase 2. III. Evaluate the efficacy (complete response [CR] with incomplete marrow recovery [CR/CRi] rate) of ADCT-602 in Phase 2.

SECONDARY OBJECTIVES:

  1. Evaluate the clinical activity of ADCT-602, based on duration of response (DOR), overall survival (OS), and progression-free survival (PFS).

II. Characterize the pharmacokinetic (PK) profile of ADCT-602. III. Evaluate the immunogenicity of ADCT-602. IV. Characterize the effect of ADCT-602 exposure on the QT interval.

EXPLORATORY OBJECTIVES:

  1. Obtain preliminary data on the correlation between the clinical activity and PK profile of ADCT-602 with the baseline expression of CD22 and other cluster of differentiation (CD) markers in peripheral blood.

II. Assess the impact of soluble CD22 (sCD22) on ADCT-602 PK.

OUTLINE: This is a dose escalation study followed by a phase II study.

Patients receive ADCT-602 intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.

Being tested
ADCT-602
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADCT-602Biological

    Also called ADCT-602 (CN); hLL2-cys-PBD (SY); ADCT602 (CN); ADCT 602 (CN); hLL2-cys-SG3249 (SY); ; ADC ADCT-602

    Starting dose of ADCT-602: 30 μg/kg given by vein.

Study groups in NCT03698552
Study groupRoleWhat they receive
ADCT-602ExperimentalPatients receive ADCT-602 by vein over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.
Receives: Biological: ADCT-602

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) as determined by dose limiting toxicities (DLTs) (Phase I)

    The MTD is the highest dose level in which the study has treated 6 patients with at most 1 experiencing the DLT. The 3+3 algorithm along with DLTs observed during the first 21 days of the first treatment cycle will be used to guide dose escalation/de-escalation.

    Measured: Up to 21 days

  2. Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE)

    Toxicity is defined as DLTs.

    Measured: Up to 1 year

  3. Recommended phase II dose of ADCT-602

    The recommended dose of ADCT-602 for phase 2 is the MTD or a dose lower than MTD, which is defined based on toxicity and efficacy profile.

    Measured: Up to 21 days

  4. Complete response (CR)/ CR with incomplete marrow recovery (CR/CRi) rate (Phase II)

    Simon's two-stage design will be used. CR/CRi rate is defined as the best response (CR/CRi) noted during the study period.

    Measured: Up to 1 year

Secondary outcomes (5)

  1. Overall response rate (ORR)

    Measured: Up to 1 year

  2. Overall survival (OS)

    Measured: Up to 1 year

  3. Progression-free survival (PFS)

    Measured: Up to 1 year

  4. Measure the amount of ADCT-602 in the body at different time points.

    Blood for testing the amount of ADCT-602 in the body at different time points drawn 4 times over the 6 hours after the dose.

    Measured: Up to 1 year

  5. ADCT-602 exposure on QT interval assessed by EKG

    Measured: Baseline up to 30 days after study drug stopped

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start24 Aug 2018
  3. Primary completion6 Nov 2025
  4. Study completion6 Nov 2025

Why it stopped: \<75% participation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03698552
Sponsor's protocol ID
2017-0938
Other IDs
NCI-2018-02016, 2017-0938
Status last verified
Dec 2025
First submitted
26 Sep 2018
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zammarchi F, Havenith KE, Sachini N, Janghra N, Chivers S, Idusogie E, Gaudio E, Tarantelli C, Bertelli F, Santos K, Tyrer P, Corbett S, Spriano F, Golino G, Cascione L, Bertoni F, Hartley JA, van Berkel PH. ADCT-602, a Novel PBD Dimer-containing Antibody-Drug Conjugate for Treating CD22-positive Hematologic Malignancies. Mol Cancer Ther. 2024 Apr 2;23(4):520-531. doi: 10.1158/1535-7163.MCT-23-0506.

    PubMed 38324336

  • Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

    PubMed 35622074

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ADCT-602 in people with Blasts 5 Percent or More of Bone Marrow Nucleated Cells and CD22 Positive, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: \<75% participation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) as determined by dose limiting toxicities (DLTs) (Phase I) (time frame: Up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03698552, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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